Clinical trial NCT02755545
Conditions: Acne
Sponsor: Galderma R&D
Start date: 2016-05-01; Completion date: 2017-04-04
Enrollment: 127 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of 2 acne treatments for 24 weeks of use in adult men and women with mild to moderate facial acne, at least 5 inflammatory lesions, and at least 10 - 100 non-inflammatory lesions.

Detailed description:
1. To characterize the effectiveness of the acne treatment in lesion count at week 1, week 2, week 6, week 12, and week 24 as compared to baseline and compare between treatments
2. To characterize the effectiveness of the acne treatment in Investigator's Global Improvement Assessment at week 1, week 2, week 6, week 12, and week 24 as compared to baseline and compare between treatments
3. To characterize the effect of the acne treatment in clinical grading of efficacy parameters through digital images at week 6, week 12, and week 24 as compared to baseline and compare between treatments
4. To characterize the effect of the acne treatment in subject self-assessment questionnaire responses at week 1, week 2, week 6, week 12, and week 24 as compared to baseline and compare between treatments

Arms: arm 1: Product A applied topically to the entire face or other affected area of the skin once daily arm 2: Product B applied topically to the affected area of the skin 1 to 3 times daily.
Interventions: intervention 1: Product A intervention 2: Product B
Intervention descriptions: intervention 1: Product A applied topically to the entire face or other affected area of the skin once daily intervention 2: Product B applied topically to affected area of the skin 1 to 3 times daily

Protocol documents:
ICF_002.pdf: 
Thomas J. Stephens & Associates, Inc. 
Stephens Study Number: C16-CD020 
Galderma Laboratories, L.P. Study Number: GLI.04.SPR.US10354 
 
Final Report 02 Jan 2018 
 
 
131 
VIII. 
Sample Forms  
Informed Consent Form 
Case Report Forms 
Questionnaires 
Daily Diary 
 


APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 20, 2016 
 
INFORMED CONSENT DOCUMENT 
AGREEMENT TO BE IN A RESEARCH STUDY 
 
NAME OF TESTING COMPANY: 
Thomas J. Stephens & Associates, Inc.  
 
NUMBER AND TITLE OF STUDY: 
C16-CD020 (GLI.04.SPR.US10354); “A Multi-
Center Clinical Trial to Evaluate the Efficacy of 
Two Acne Treatments” 
NAME OF PERSON IN CHARGE OF  
THE RESEARCH STUDY 
 (STUDY DOCTOR/INVESTIGATOR): 
Lily Jiang, Ph.D. 
 
TELEPHONE NUMBER(S), DAYTIME: 
 
972-392-1529 
AFTER HOURS:   
 
 
 
 
469-766-4781 
 
 
INTRODUCTION 
 
You are being invited to volunteer for a clinical research study.  You must read and sign this form before 
you agree to take part in this study.  This form will give you more information about this study.  Please ask 
as many questions as you need to before you decide if you want to be in the study.  You should not sign this 
form if you have any questions that have not been answered. 
 
Thomas J. Stephens & Associates, Inc., a contract research organization, is being paid by the sponsor (the 
company paying for this study) to conduct this research study.   
 
You must be honest with the Investigator about your health history or it may not be safe for you to be in this 
study. 
 
PURPOSE OF THE STUDY 
 
The purpose of this study is to evaluate the efficiency of 2 acne treatments for 24 weeks of use in adult 
men and women with mild to moderate facial acne, at least 5 inflammatory lesions, and at least 10 – 100 
non-inflammatory lesions. 
 
HOW LONG THE STUDY WILL LAST AND HOW MANY PEOPLE WILL BE IN THE STUDY 
 
This study will last 24 weeks and have up to 8 visits. At least 100 subjects, men and women between the 
ages of 21-45, are expected to complete this study, with at least 50 subjects completed per cell. Each site 
is to enroll no more than 40 subjects, with at least 100 subjects expected to complete when combined. 
 
TO BE IN THIS STUDY 
 
You must: 
 
• 
Be a man or woman age 21 to 45 years at the time of enrollment. 
• 
Have mild to moderate acne on the face as determined by the Investigator or designee. 
• 
Have at least 5 inflammatory lesions as determined by the Investigator or designee. 
• 
Have 10 – 100 non-inflammatory lesions as determined by the Investigator or designee. 
• 
Be willing to use the test products as instructed for 24 weeks.  
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
Page 2 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 20, 2016 
 
• 
Be willing and able to comply with all of the time commitments and procedural requirements of the 
clinical trial protocol. 
• 
Be willing to provide written informed consent including photo release, Health Insurance Portability 
and Accountability Act (HIPAA), and be able to read, speak, write, understand English and be willing 
to share personal information and data, as verified by signing a written authorization at the screening. 
• 
Be willing to withhold all facial treatments during the course of the study including botulinum toxin, 
injectable fillers, microdermabrasion, IPL, peels, facials, laser treatments and tightening treatments.  
Waxing and threading is allowed but not facial laser hair removal. 
• 
Males must be regular shavers and willing to shave on the day of the study visits (prior to clinic 
visits). 
• 
Women of child bearing potential must be willing to take a urine pregnancy test prior to study 
enrollment, at week 24, and when deemed appropriate by the Investigator and/or Sponsor. 
• 
Individuals of child bearing potential must use an acceptable method of contraception throughout the 
study.  Acceptable methods of birth control include: 
o Oral and other system contraceptives. Individuals must be on a stable use for 3 
months prior to study enrollment. Individuals on oral contraceptives must not alter 
their use, including dose or regimen for the duration of the study 
o Double barrier 
o Bilateral tubal ligation (tubes tied) 
o Partner vasectomy 
o Abstinence 
• 
Be willing to follow study requirements and report any changes in health status or medications, side 
effect symptoms, or reactions immediately. 
• 
Be stable on any medication you are taking for at least 30 days 
 
YOU CANNOT BE ON THE STUDY 
 
If you: 
 
• 
Have been diagnosed with allergies to topical acne products. 
• 
Have a condition and/or disease of the skin that the Investigator deems inappropriate for participation. 
• 
Are a woman who is breastfeeding, pregnant, or planning to become pregnant during the study. 
• 
Have pre-existing or dormant dermatologic conditions on the face (e.g., psoriasis, rosacea, eczema, 
seborrheic dermatitis, severe excoriations etc.) which in the opinion of the Investigator could interfere 
with the outcome of the study. 
• 
Have a history of immunosuppression/immune deficiency disorders (including HIV infection or 
AIDS) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, 
cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, 
Remicade, Stelara.).  
• 
Have an uncontrolled disease such as asthma, diabetes, hypertension, hyperthyroidism, or 
hypothyroidism. Individuals having multiple health conditions may be excluded from participation 
even if the conditions are controlled by diet, medication, etc. at the Investigator’s discretion. 
• 
Are currently participating in another facial usage study or have participated in a clinical trial within 4 
weeks prior to inclusion into the study. 
• 
Have a history of skin cancer on the face within the past 5 years. 
• 
Have any planned surgeries and/or invasive medical procedures during the course of the study. 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
Page 3 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 20, 2016 
 
• 
Have started hormone replacement therapies (HRT) or hormones for birth control less than 3 months 
prior to study entry or plan on starting, stopping, or changing doses of HRT or hormones for birth 
control during the study. 
• 
Have facial sunburn or excessive tanned facial skin or are not willing to avoid daily sun exposure on 
the face and the use of tanning beds or sunless tanning products for the duration of the study. 
• 
Have severe acne, acne conglobata, multiple nodules or cysts (more than 2). 
• 
Are currently taking a natural or prescription testosterone blocker (e.g. saw palmetto, blask cohosh, 
chaste tree, chasteberry, spironolactone, drospirenone, progestins). 
• 
Are currently on a testosterone booster or prescription testosterone (e.g. DHEA, tribulus, testosterone 
cypionate, testosterone enanthate, Sustanon, testosterone propionate, testosterone phenylpropriate, 
Omnadren etc.). 
• 
Are currently taking or have taken within the last 30 days oral or topical prescription medications for 
acne such as Doxycycline, Minocycline, Clindamycin, Bactrim, Tetracycline, Erythromycin, 
Vibramycin and topical tretinoin (Retin A, Renova, Adapalene, Tazarotene), Azelaic acid, benzoyl 
peroxide, Dapsone, Sodium sulfacetamide, Differin, Epiduo. 
• 
Have used oral isotretinoin (Accutane) within the past 6-months. 
• 
Are routinely using (3x a week or more) topical over-the-counter (OTC) acne product (e.g. benzoyl 
peroxide, salicylic acid, alpha hydroxyl, beta hydroxyl and/or poly-hydroxy products or medicated 
cleansers, wipes, masks, scrubs, gels and creams) within 14 days of the study entry. 
• 
Are using or have used any systemic medication considered to affect the course of acne, specifically, 
but not exclusively antibiotics or steroids within the last 30 days prior to entry into the study. 
• 
Have excessive facial hair, including beard, mustache or goatee, or scars, which could interfere with 
evaluations as determined by the Investigator or designee. 
 
WHAT WILL HAPPEN DURING THE STUDY 
 
*Visit 1: Screening (* Visit 1 {Screening} AND Visit 2 {Baseline} may be combined into 1 Visit) 
 
You will: 
 
• 
Be given an IRB-approved Informed Consent Form (ICF), to read and sign. You will be given enough 
time to read the informed consent, and ask questions about the study, and sign 2 copies of this consent 
form. (1 for clinic records, 1 for your records) 
• 
Be given an eligibility and health questionnaire to complete, and assigned a screening number. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Will be screened by the Investigator or designee to see if you qualify for the study. 
• 
If you do qualify for the study, you will: 
o Take a urine pregnancy test (females of child-bearing potential) 
o Have a dermatologist confirm your eligibility 
o Schedule your next appointment. 
 
*Visit 2: Baseline 
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Be screened by the Investigator or designee to see if you still qualify for the study. 
• 
Have your health and eligibility re-reviewed. 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
Page 4 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 20, 2016 
 
• 
If you still qualify for the study you will: 
o Be assigned a subject number 
o Have photos taken of your face 
o Be randomly assigned to receive one of the test products & supporting facial cleanser, 
moisturizer & facial SPF 30  
o Be provided verbal and written usage instructions, and a daily diary to record product use 
o Schedule your next appointment 
 
 
Visits 3, 4 (Week 1, Week 2)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and returned to you. At week 2, your diary 
will be retained by the testing facility and you will be given a new diary 
• 
Have your product collected, weighed, and returned to you 
• 
Schedule your next appointment 
 
Visits 5, 6 (Week 6, Week 12)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Have photos taken of your face 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility and you 
will be given a new diary. 
• 
Have your product collected, weighed, and retained. New products will be dispensed as necessary. 
• 
Schedule your next appointment 
 
Visit 7 (Week 18)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility and you 
will be given a new diary. 
• 
Have your product collected, weighed, and returned to you 
• 
Schedule your next appointment 
 
Visit 8 (Week 24)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Take a urine pregnancy test (females of child-bearing potential). 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Have photos taken of your face 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility. 
• 
Have your product collected, weighed, and retained by the testing facility. 
 
Do not give the study product to other people and keep it out of the reach of children. 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
Page 5 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 20, 2016 
 
RISKS OR DISCOMFORTS 
 
If you do not understand what any of these side effects mean, please ask the investigator or study staff to 
explain these terms to you.  
 
Because the study products are investigational, all of their side effects may not be known.  There may be 
rare and unknown side effects. Some of these may be life threatening. 
 
Possible risks associated with the product are, as with any other cosmetic and OTC products, signs of 
irritation including:  
 
• 
Itching 
• 
Burning 
• 
Stinging 
• 
Rash or other allergic reaction 
• 
Tingling 
• 
Scaling/Dryness 
• 
Redness 
 
In some cases, it is possible for a subject to develop allergic reactions to the test material(s). This risk is 
increased for individuals with a history of allergies, and individuals with asthma and/or a history of hives 
may also be affected. Symptoms include rash, hives, and itching. 
 
You must tell the Investigator or study staff about all side effects that you have. If you are not honest 
about your side effects, it may not be safe for you to stay in the study. 
 
BIRTH CONTROL, DANGERS OF PREGNANCY AND BREASTFEEDING 
 
If you are a female, you must not get pregnant while in this study. The only certain way to not get 
pregnant is to not have sex.  If you are a female and choose to have sex, you must use a type of birth 
control.   
 
Even if you use birth control during the study, there is a chance you could become pregnant.  If you are 
pregnant or become pregnant during the study, test products or procedures may involve unforeseeable 
risks to the unborn baby. 
 
A pregnancy test can be wrong.  If you become pregnant during the study, stop using the test products and 
call/inform the Investigator at once. 
 
You cannot be in the study if you are breastfeeding.  It is not known whether the test products are safe for 
breast fed babies.  Therefore if you are breastfeeding a child then it may not be safe for you to participate 
in the study.   
 
POSSIBLE BENEFITS OF THE STUDY 
 
You will not get any medical benefit from being in this study, and there is no promise that your condition 
(acne) will get better.  It might stay the same or it might get worse.  Your participation will provide 
information that may help others. There may be other marketed products that claim to have similar 
benefits. 
 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
Page 6 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 20, 2016 
 
OTHER OPTIONS TO PARTICIPATING IN THE STUDY   
 
Since this study is for research only, the only other choice would be not to be in the study. 
 
STUDY AND TEST PRODUCT CONFIDENTIALITY 
 
To participate in this study, you must agree to keep any information relating to the design, identity or use 
of these test product samples confidential.  
 
On rare occasions, the sponsor may allow the testing company to disclose to you the name of the test 
products if you are not given this information during the study. This information is typically not provided 
until the end of the study or after the test products have been released for sale to the public. The study 
doctor or study staff will notify you if the sponsor allows us to give you this information. 
 
DISCLOSURE AGREEMENT 
 
This section explains how personal health information collected about you for the study may be used.  
Your personal health information includes, but is not limited to, information that was collected for your 
entry into the study and information that is collected during the study.  The purpose of collecting this 
information is to allow the study staff and the Investigator to conduct the study, to evaluate the sponsor’s 
study products and to analyze the study results.   
 
You may decide not to give permission for the release of your personal health information for the study.  
In that case, you will not be able to participate in the study.   This is because the study staff and/or the 
Investigator would not be able to collect the information needed to evaluate the sponsor’s study products. 
 
People who may inspect your personal and health information includes the Investigator, the Institutional 
Review Board, IntegReview IRB, FDA and other regulatory authorities from the United States or other 
countries, the study sponsor and people that work with the sponsor which includes, monitoring 
committees, contract research organizations, and consultants who have contracts with the company to do 
the study and review the study results. These reviews are done to check on the quality of the study and 
also for other purposes allowed by law. 
 
The results of the study may be published in a medical book or journal, or presented at meetings for 
educational purposes.  Neither your name, nor any other personal health information that specifically 
identifies you, will be used in those materials or presentations.    
 
You may ask the Investigator to see and copy your personal health information related to the study.  You 
may also ask the Investigator to correct any study related information about you that is wrong.  You may 
have to wait until the end of the study to see your study records, so that the study can be organized 
properly.   
 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
Page 7 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 20, 2016 
 
This permission to share your personal health information for this study does not have an expiration date.  
If you no longer want to share your personal health information, you may cancel your permission at any 
time by writing to the study staff and/or the Investigator at the address below: 
 
Thomas J. Stephens & Associates, Inc. 
1801 North Glenville Drive, Suite 200 
Richardson, TX  75081 
 
If you cancel your permission after you have started in the study, the study staff and the Investigator will 
stop collecting your personal health information.  Although they will stop collecting new information 
about you, they will need to use the information they have already collected to evaluate the study results.  
If you start the study and then cancel your permission, you will not be able to continue to participate in 
the study.  This is because the study staff and/or the Investigator would not be able to collect the 
information needed to evaluate the study.  
 
Thomas J. Stephens & Associates and the sponsor will make every effort to keep your personal health 
information private.  But after the study staff or the Investigator share your personal health information 
from the study, federal privacy laws may not keep it private.  There might be laws in your state or other 
federal laws that would protect the privacy of this information. 
 
CONFIDENTIALITY  
 
Your records of being in this study will be kept private except when ordered by law.    The following 
people will have access to your study records: 
 
• 
The Investigator 
• 
Sponsor company or research institution [including monitor(s) and auditor(s)] 
• 
Other country, state or federal regulatory agencies 
• 
IntegReview IRB 
 
The Institutional Review Board (IRB), IntegReview, and accrediting agencies may inspect and copy your 
records, which may have your name on them.  Therefore, total confidentiality cannot be guaranteed.  If 
the study results are presented at meetings or printed in publications, your name will not be used. 
  
IN CASE OF STUDY RELATED INJURY 
 
Side effects or complications, both foreseeable and unforeseeable, are possible in any research study 
without any fault to you, the Investigator, the study site, or the study sponsor. If you get hurt or sick as a 
direct result of being in this study, the sponsor will pay the costs of reasonable medical treatment.  To ask 
questions about this, talk to the Investigator or study staff.   
 
The sponsor’s policy does not offer compensation for other expenses.  Be aware that your health care 
payer/insurer might not cover the costs of study-related injuries or illnesses. 
 
Unreimbursed medical expenses not covered by insurance or other third party coverage will be 
reimbursed by the sponsor for medical treatment for any injury that, in the opinion of the study doctor and 
the sponsor, is directly caused by the investigational product or by procedures required by the study 
protocol which would not have been performed as part of your regular medical care. 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
Page 8 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 20, 2016 
 
LEGAL RIGHTS 
 
You will not lose any of your legal rights by signing this consent form. 
 
CONTACT INFORMATION 
 
If you have questions, concerns, or complaints about this study or to report a study related injury, contact: 
 
Lily Jiang, Ph.D. 
972-392-1529 daytime telephone number  
469-766-4781 after hours number 
 
If you are unable to reach anyone at the number(s) listed above and you need medical attention, 
please go to the nearest emergency room. 
 
If you do not want to talk to the Investigator or study staff, if you have concerns or complaints about the 
research, or to ask questions about your rights as a study subject you may contact IntegReview.  
IntegReview’s policy indicates that all concerns/complaints are to be submitted in writing for review at a 
convened IRB meeting to: 
 
Mailing Address:            OR            Email Address: 
Chairperson 
IntegReview IRB 
3815 S. Capital of Texas Highway 
Suite 320 
Austin, TX  78704 
integreview@integreview.com 
 
If you are unable to provide your concerns/complaints in writing or if this is an emergency situation 
regarding subject safety, contact our office at: 
 
512-326-3001 or 
toll free at 1-877-562-1589 
between 8 a.m. and 5 p.m. Central Time 
 
IntegReview has approved the information in this consent form and has given approval for the 
Investigator to do the study. This does not mean IntegReview has approved your being in the study.  You 
must consider the information in this consent form for yourself and decide if you want to be in this study. 
 
PAYMENT FOR BEING IN THE STUDY 
 
You may receive up to $575.00 for being in the study. You will be paid per completed visit as follows: 
   
Visit 
Compensation (amount) 
Screening/Baseline (Visit 1) 
$40.00 
Week 1 (Visit 2) 
$60.00 
Week 2 (Visit 3) 
$65.00 
Week 6 (Visit 4) 
$75.00 
Week 12 (Visit 5) 
$90.00 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
Page 9 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 20, 2016 
 
Week 18 (Visit 6) 
$95.00 
Week 24 (Visit 7) 
$150.00 
 
If you choose to leave or are withdrawn from the study for any reason before finishing all visits you will 
be paid for each completed visit.  You will receive payment within 2 weeks of final study visit. 
 
If you do not qualify for any reason, you will be paid $20.00, which will be mailed to you within 2 weeks 
of the baseline study visit. 
 
If you are paid $600.00 or more by Thomas J. Stephens & Associates, Inc. in a calendar year, those 
payments will be reported to the Internal Revenue Service via form 1099-MISC. As required by tax laws, 
if you withhold your social security number, Thomas J. Stephens & Associates, Inc. is required to 
withhold 28% of your payment for tax purposes. In this case a form 1099-MISC will be sent to you 
reporting your withholding. 
 
VOLUNTEERING TO BE IN THE STUDY 
 
It is your choice if you want to be in the study.  No one can force you to be in the study.  You may not 
want to be in this study or you may leave the study at any time without penalty or loss of benefits to 
which you are otherwise entitled.   
 
The Investigator, the sponsor company, or IntegReview may take you out of the study without your 
permission, at any time, for the following reasons: 
 
 
• 
If you do not follow the Investigator’s instructions  
• 
If we find out you should not be in the study 
• 
If the study is stopped 
• 
If it becomes harmful to your health 
 
If you leave the study or if you are taken out of the study, you may be asked to return for a final visit to 
have some end of study evaluations or tests.  If information generated from this study is published or 
presented, your identity will not be revealed.  If you leave the study, no more information about you will 
be collected for this study.  However, all of the information you gave us before you left the study will still 
be used.  
 
NEW FINDINGS 
 
If there is new information or any significant new findings that could relate to your willingness to 
continue participation we will tell you.  You can then decide if you still want to be in the study.   
 
THE REASON FOR INSTITUTIONAL REVIEW BOARDS AND INFORMED CONSENT 
 
What is a consent form? 
The informed consent document contains information required by federal regulations.  The informed 
consent document must be approved by an Institutional Review Board (IRB). 
 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
Page 10 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 20, 2016 
 
What is an Institutional Review Board (IRB)? 
An Institutional Review Board (IRB) is a group of people that reviews research studies.  The main goal of 
this review is to protect the rights and well being of the human subjects participating in research studies. 
 
IntegReview, the IRB for this study 
IntegReview is an IRB whose board members provide IRB services across the United States, Canada, 
Japan and Latin America. 
 
To meet requirements of the law, the IntegReview Boards currently include:  
 
• 
Doctors  
• 
Pharmacists  
• 
Nurses  
• 
Toxicologists (people who study the harmful effects of chemicals)  
• 
Other specialists 
• 
Others who do not have a background in science/medicine 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
Page 11 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 20, 2016 
 
AGREEMENT TO BE IN THE STUDY 
 
This consent form contains important information to help you decide if you want to be in the study.  If 
you have any questions that are not answered in this consent form, ask one of the study staff.  
 
Please answer YES or NO to the following questions: 
 
A. 
Is this document in a language you understand?  
 
 
 
 
 
 
 
B. 
Do you understand the information in this consent form?  
 
 
 
 
 
 
C. 
Have you been given enough time to ask questions and talk about the study? 
 
 
 
 
D. 
Have all of your questions been answered to your satisfaction? 
 
 
 
 
 
 
E. 
Do you think you received enough information about the study?  
 
 
 
 
 
F. 
Do you volunteer to be in this study of your own free will and without being  
pressured by the Investigator or study staff? 
 
 
 
 
 
 
 
 
G. 
Do you know that you can leave the study at any time without giving 
a reason and without affecting your health care?  
 
 
 
 
 
 
 
H. 
Do you know that your health records from this study may be reviewed 
by the sponsor company and by government authorities?  
 
 
 
 
 
 
I. 
Do you know that you cannot be in another study while you are in this study? 
 
 
 
 
IF YOU ANSWERED “NO” TO ANY OF THE ABOVE QUESTIONS, 
OR YOU ARE UNABLE TO ANSWER ANY OF THE ABOVE QUESTIONS, 
YOU SHOULD NOT SIGN THIS CONSENT FORM. 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
  
 
 
 
 
 
 
 
 
 
 
Printed Name of Person Explaining Consent Form 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Person Explaining Consent Form 
 
 
 
 
 
Date 
 
 
 
You will be given a signed and dated copy of this consent form to keep. 
 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
Page 12 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 20, 2016 
 
Authorization and Release Form 
 
I hereby for good and valuable consideration grant to Thomas J. Stephens & Associates, the study 
sponsor and their respective affiliates, agencies, agents, employees, and assigns (collectively, “Authorized 
Entities”), the unrestricted, royalty free, irrevocable and perpetual right and permission to reproduce, 
distribute, broadcast and/or otherwise use for advertising and other commercial/noncommercial purposes:  
(i) my name, likeness, image, video, and any other biographical or personal information (“Personal 
Content”); and (ii) any statement or endorsement, or any portions thereof (“Testimonial(s)”), made by me 
relating to the study sponsor’s products (“Products”), in any and all media now known or later developed, 
worldwide in perpetuity, without further compensation or approval by me.     
 
I hereby assign to the Authorized Entities all of my world-wide right, title and interest, including my 
copyright interests and all renewals, reissues and extensions thereof, in and to the Personal Content and 
Testimonial(s), including without limitation, any photographic portraits, sound recordings and video 
performances of and/or by me in connection with the Personal Content and/or Testimonial(s).    
  
I am at least 21 years of age, and competent to contract in my own name.  I have read and understand this 
Authorization and Release. 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Person Explaining Release Form 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Person Explaining Release Form 
 
 
 
 
 
Date  
 
 
 
Copy of consent form given to subject on ______________ (date) by ______________ (initials) 
 
You will be given a signed and dated copy of this consent form to keep. 
 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
Page 13 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 20, 2016 
 
AUTHORIZATION TO USE AND DISCLOSE PERSONAL HEALTH INFORMATION FOR 
RESEARCH 
  
THIS SECTION DESCRIBES YOUR RIGHTS AND HOW PERSONAL HEALTH INFORMATION 
COLLECTED ABOUT YOU DURING THIS STUDY MAY BE USED AND DISCLOSED AND HOW 
YOU CAN GET ACCESS TO THIS INFORMATION.  PLEASE REVIEW IT CAREFULLY. 
  
The United States government has issued a privacy rule to protect the privacy rights of patients.  This rule 
was issued under a law called the Health Insurance Portability and Accountability Act of 1996 
(HIPAA).  The Privacy Rule is designed to protect the confidentiality of your personal health 
information.  The document you are reading, called an “Authorization,” describes your rights and 
explains how your health information will be used and disclosed (shared). 
  
Federal law requires hospitals, researchers and health care providers to protect the privacy of information 
that identifies you and relates to your past, present and future physical and mental health or conditions. 
  
All information collected during the study will be retained by the study doctor and the Study Sponsor, 
except as required by law.  Information from this study will be given to the sponsor.  “Sponsor” includes 
any persons or companies, which are contracted by the sponsor to have access to the research information 
during and after the study.  The information will also be given to the U.S. Food and Drug Administration 
(FDA).  Study records which identify you and the consent form signed by you will be inspected and/or 
copied for research or regulatory purposes by: 
  
• 
Sponsor  
• 
Agents for the sponsor 
• 
The US Food and Drug Administration (FDA) 
• 
Department of Health and Human Services (DHHS) agencies 
• 
IntegReview IRB  
  
Because of the need to release information to these parties, absolute confidentiality cannot be 
guaranteed.  The results of this research study may be presented at meetings or in publications; however, 
your identity will not be disclosed in those presentations. 
  
For purposes of study reporting, you will be identified by your initials and code numbers only.  However, 
your name, date of birth, address, and phone number will be kept on record by the study doctor in case 
you need to be contacted in the future about this study. 
  
After your personal health information is disclosed to the Study Sponsor, the results of the study may be 
reanalyzed at a later date and may be combined with the results of other studies.   The Study Sponsor and 
people who work with the Study Sponsor may use the results of this study for other research purposes, 
including:  
  
• 
Developing a better understanding of the disease; 
• 
Improving the design of future actual use trials 
  
After the study staff or the study doctor discloses your personal health information to others, it could be 
re-disclosed and no longer protected by federal privacy laws. 
  
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
Page 14 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 20, 2016 
 
This permission to share your personal health information for this study does not have an expiration 
date.  If you do not withdraw this Authorization in writing, it will remain in effect indefinitely. Your 
study doctor will keep this Authorization for at least 6 years.  If you no longer want to share your personal 
health information, you may cancel your permission at any time by writing to the study staff and/or the 
study doctor at the address below: 
 
Thomas J. Stephens & Associates, Inc. 
1801 North Glenville Drive, Suite 200 
Richardson, TX  75081 
 
You have the right to see and get a copy of your records related to the study for as long as the study 
doctor has this information.  However, by signing this Authorization you agree that you might not be able 
to review or receive some of your records related to the study until after the study has been completed. 
  
If you cancel your permission after you have started in the study, the study staff and the study doctor will 
stop collecting your personal health information unless the information concerns an adverse event (a bad 
effect) related to the study.  If an adverse event occurs, your entire medical record may be reviewed.  All 
information that has already been collected for study purposes, and any new information about an adverse 
event related to the study, will be sent to the study sponsor.  Although they will stop collecting new 
information about you, they will need to use the information they have already collected to evaluate the 
study results.  If you start the study and then cancel your permission, you will not be able to continue to 
participate in the study.  This is because the study staff and/or the study doctor would not be able to 
collect the information needed to evaluate the study results. 
  
If you withdraw from the study but do not withdraw your Authorization, new personal health information 
may be collected until this study ends.  
  
You may decide not to give permission for the release of your personal health information for this 
study.  In that case, you will not be able to participate.  This is because the study staff and study doctor 
would not be able to collect the information needed to evaluate the study results. 
  
At the completion of the study, you have the right to access your protected health information that is 
created during this research study that relates to your treatment or to payment, provided such information 
is not exempted under certain laws and regulations.  To request this information, please contact the study 
doctor at the address listed above. 
  
Your Right to Access Health Information 
 
Subject to certain exceptions prescribed by law, you have a right to request access to the health 
information that we hold about you and to request changes if your health information is incorrect or 
incomplete. Any request for access or corrections should be made to the principal doctor conducting this 
study. 
 
Your records obtained while you are in this trial, as well as related health records, will remain strictly 
confidential at all times.  However, these will need to be made available to others working on the 
Sponsor’s behalf, the Independent Ethics Committee members and Medicines Regulatory Authorities. 
 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
Page 15 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 20, 2016 
 
By signing the consent form you agree to this access for the current trial and any further research that may 
be done.  However, the Sponsor will take steps to protect your personal information and will not include 
your name on any sponsor forms, reports, publications, or in any future disclosures.  If you withdraw 
from the study, we will no longer collect your personal information, but we may need to continue to use 
information already collected. 
 
Personal data which may be sensitive (e.g., date of birth) will be collected and processed, but only for 
research purposes in connection with this trial. 
 
The trial data will be sent around the world, but you will not be referred to by name or identified in any 
report or publication nor could the data be traced back to you.  Your data may be transferred to a country 
that does not have the same level of personal data protection as within the United States.  However, 
The Sponsor maintains high standards of confidentiality and protection. 
 
The Sponsor (who will control the use of the data) will take steps to ensure your personal data is 
protected. 
 
By taking part in this trial you agree not to restrict the use of any data even if you withdraw from the trial 
and agree to the transfer of your personal data to other Sponsor companies and to Medicines Regulatory 
Authorities both within and outside of Europe. 
 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
 
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APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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INFORMED CONSENT DOCUMENT 
AGREEMENT TO BE IN A RESEARCH STUDY 
 
NAME OF TESTING COMPANY: 
Thomas J. Stephens & Associates, Inc.  
 
NUMBER AND TITLE OF STUDY: 
C16-CD020 (GLI.04.SPR.US10354); “A Multi-
Center Clinical Trial to Evaluate the Efficacy of 
Two Acne Treatments” 
NAME OF PERSON IN CHARGE OF  
THE RESEARCH STUDY 
 (STUDY DOCTOR/INVESTIGATOR): 
Lily Jiang, Ph.D. 
 
TELEPHONE NUMBER(S), DAYTIME: 
 
972-392-1529 
AFTER HOURS:   
 
 
 
 
469-766-4781 
 
 
INTRODUCTION 
 
You are being invited to volunteer for a clinical research study.  You must read and sign this form before 
you agree to take part in this study.  This form will give you more information about this study.  Please ask 
as many questions as you need to before you decide if you want to be in the study.  You should not sign this 
form if you have any questions that have not been answered. 
 
Thomas J. Stephens & Associates, Inc., a contract research organization, is being paid by the sponsor (the 
company paying for this study) to conduct this research study.   
 
You must be honest with the Investigator about your health history or it may not be safe for you to be in this 
study. 
 
PURPOSE OF THE STUDY 
 
The purpose of this study is to evaluate the efficiency of 2 acne treatments for 24 weeks of use in adult 
men and women with mild to moderate facial acne, at least 5 inflammatory lesions, and at least 10 – 100 
non-inflammatory lesions. 
 
HOW LONG THE STUDY WILL LAST AND HOW MANY PEOPLE WILL BE IN THE STUDY 
 
This study will last 24 weeks and have up to 8 visits. At least 100 subjects, men and women between the 
ages of 21-45, are expected to complete this study, with at least 50 subjects completed per cell.  
 
TO BE IN THIS STUDY 
 
You must: 
 
• 
Be a man or woman age 21 to 45 years at the time of enrollment. 
• 
Have mild to moderate acne on the face as determined by the Investigator or designee. 
• 
Have at least 5 inflammatory lesions as determined by the Investigator or designee. 
• 
Have 10 – 100 non-inflammatory lesions as determined by the Investigator or designee. 
• 
Be willing to use the test products as instructed for 24 weeks.  
• 
Be willing and able to comply with all of the time commitments and procedural requirements of the 
clinical trial protocol. 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
Page 2 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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• 
Be willing to provide written informed consent including photo release, Health Insurance Portability 
and Accountability Act (HIPAA), and be able to read, speak, write, understand English and be willing 
to share personal information and data, as verified by signing a written authorization at the screening. 
• 
Be willing to withhold all facial treatments during the course of the study including botulinum toxin, 
injectable fillers, microdermabrasion, IPL, peels, facials, laser treatments and tightening treatments.  
Waxing and threading is allowed but not facial laser hair removal. 
• 
Males must be regular shavers and willing to shave on the day of the study visits (prior to clinic 
visits). 
• 
Women of child bearing potential must be willing to take a urine pregnancy test prior to study 
enrollment, at week 24, and when deemed appropriate by the Investigator and/or Sponsor. 
• 
Individuals of child bearing potential must use an acceptable method of contraception throughout the 
study.  Acceptable methods of birth control include: 
o Oral and other system contraceptives. Individuals must be on a stable use for 3 
months prior to study enrollment. Individuals on oral contraceptives must not alter 
their use, including dose or regimen for the duration of the study 
o Double barrier 
o Bilateral tubal ligation (tubes tied) 
o Partner vasectomy 
o Abstinence 
• 
Be willing to follow study requirements and report any changes in health status or medications, side 
effect symptoms, or reactions immediately. 
• 
Be stable on any medication you are taking for at least 30 days 
 
YOU CANNOT BE ON THE STUDY 
 
If you: 
 
• 
Have been diagnosed with allergies to topical acne products. 
• 
Have a condition and/or disease of the skin that the Investigator deems inappropriate for participation. 
• 
Are a woman who is breastfeeding, pregnant, or planning to become pregnant during the study. 
• 
Have pre-existing or dormant dermatologic conditions on the face (e.g., psoriasis, rosacea, eczema, 
seborrheic dermatitis, severe excoriations etc.) which in the opinion of the Investigator could interfere 
with the outcome of the study. 
• 
Have a history of immunosuppression/immune deficiency disorders (including HIV infection or 
AIDS) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, 
cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, 
Remicade, Stelara.).  
• 
Have an uncontrolled disease such as asthma, diabetes, hypertension, hyperthyroidism, or 
hypothyroidism. Individuals having multiple health conditions may be excluded from participation 
even if the conditions are controlled by diet, medication, etc. at the Investigator’s discretion. 
• 
Are currently participating in another facial usage study or have participated in a clinical trial within 4 
weeks prior to inclusion into the study. 
• 
Have a history of skin cancer on the face within the past 5 years. 
• 
Have any planned surgeries and/or invasive medical procedures during the course of the study. 
• 
Have started hormone replacement therapies (HRT) or hormones for birth control less than 3 months 
prior to study entry or plan on starting, stopping, or changing doses of HRT or hormones for birth 
control during the study. 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
Page 3 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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• 
Have facial sunburn or excessive tanned facial skin or are not willing to avoid daily sun exposure on 
the face and the use of tanning beds or sunless tanning products for the duration of the study. 
• 
Have severe acne, acne conglobata, multiple nodules or cysts (more than 2). 
• 
Are currently taking a natural or prescription testosterone blocker (e.g. saw palmetto, blask cohosh, 
chaste tree, chasteberry, spironolactone, drospirenone, progestins). 
• 
Are currently on a testosterone booster or prescription testosterone (e.g. DHEA, tribulus, testosterone 
cypionate, testosterone enanthate, Sustanon, testosterone propionate, testosterone phenylpropriate, 
Omnadren etc.). 
• 
Are currently taking or have taken within the last 30 days oral or topical prescription medications for 
acne such as Doxycycline, Minocycline, Clindamycin, Bactrim, Tetracycline, Erythromycin, 
Vibramycin and topical tretinoin (Retin A, Renova, Adapalene, Tazarotene), Azelaic acid, benzoyl 
peroxide, Dapsone, Sodium sulfacetamide, Differin, Epiduo. 
• 
Have used oral isotretinoin (Accutane) within the past 6-months. 
• 
Are routinely using (3x a week or more) topical over-the-counter (OTC) acne product (e.g. benzoyl 
peroxide, salicylic acid, alpha hydroxyl, beta hydroxyl and/or poly-hydroxy products or medicated 
cleansers, wipes, masks, scrubs, gels and creams) within 14 days of the study entry. 
• 
Are using or have used any systemic medication considered to affect the course of acne, specifically, 
but not exclusively antibiotics or steroids within the last 30 days prior to entry into the study. 
• 
Have excessive facial hair, including beard, mustache or goatee, or scars, which could interfere with 
evaluations as determined by the Investigator or designee. 
 
WHAT WILL HAPPEN DURING THE STUDY 
 
*Visit 1: Screening (* Visit 1 {Screening} AND Visit 2 {Baseline} may be combined into 1 Visit) 
 
You will: 
 
• 
Be given an IRB-approved Informed Consent Form (ICF), to read and sign. You will be given enough 
time to read the informed consent, and ask questions about the study, and sign 2 copies of this consent 
form. (1 for clinic records, 1 for your records) 
• 
Be given an eligibility and health questionnaire to complete, and assigned a screening number. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Will be screened by the Investigator or designee to see if you qualify for the study. 
• 
If you do qualify for the study, you will: 
o Take a urine pregnancy test (females of child-bearing potential) 
o Have a dermatologist confirm your eligibility 
o Schedule your next appointment. 
 
*Visit 2: Baseline 
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Be screened by the Investigator or designee to see if you still qualify for the study. 
• 
Have your health and eligibility re-reviewed. 
• 
If you still qualify for the study you will: 
o Be assigned a subject number 
o Have photos taken of your face 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
Page 4 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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o Be randomly assigned to receive one of the test products & supporting facial cleanser, 
moisturizer & facial SPF 30  
o Be provided verbal and written usage instructions, and a daily diary to record product use 
o Schedule your next appointment 
 
 
Visits 3, 4 (Week 1, Week 2)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and returned to you. At week 2, your diary 
will be retained by the testing facility and you will be given a new diary 
• 
Have your product collected, weighed, and returned to you 
• 
Schedule your next appointment 
 
Visits 5, 6 (Week 6, Week 12)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Have photos taken of your face 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility and you 
will be given a new diary. 
• 
Have your product collected, weighed, and retained. New products will be dispensed as necessary. 
• 
Schedule your next appointment 
 
Visit 7 (Week 18)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility and you 
will be given a new diary. 
• 
Have your product collected, weighed, and returned to you 
• 
Schedule your next appointment 
 
Visit 8 (Week 24)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Take a urine pregnancy test (females of child-bearing potential). 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Have photos taken of your face 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility. 
• 
Have your product collected, weighed, and retained by the testing facility. 
 
Do not give the study product to other people and keep it out of the reach of children. 
 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
Page 5 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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RISKS OR DISCOMFORTS 
 
If you do not understand what any of these side effects mean, please ask the investigator or study staff to 
explain these terms to you.  
 
Because the study products are investigational, all of their side effects may not be known.  There may be 
rare and unknown side effects. Some of these may be life threatening. 
 
Possible risks associated with the product are, as with any other cosmetic and OTC products, signs of 
irritation including:  
 
• 
Itching 
• 
Burning 
• 
Stinging 
• 
Rash or other allergic reaction 
• 
Tingling 
• 
Scaling/Dryness 
• 
Redness 
 
In some cases, it is possible for a subject to develop allergic reactions to the test material(s). This risk is 
increased for individuals with a history of allergies, and individuals with asthma and/or a history of hives 
may also be affected. Symptoms include rash, hives, and itching. 
 
You must tell the Investigator or study staff about all side effects that you have. If you are not honest 
about your side effects, it may not be safe for you to stay in the study. 
 
BIRTH CONTROL, DANGERS OF PREGNANCY AND BREASTFEEDING 
 
If you are a female, you must not get pregnant while in this study. The only certain way to not get 
pregnant is to not have sex.  If you are a female and choose to have sex, you must use a type of birth 
control.   
 
Even if you use birth control during the study, there is a chance you could become pregnant.  If you are 
pregnant or become pregnant during the study, test products or procedures may involve unforeseeable 
risks to the unborn baby. 
 
A pregnancy test can be wrong.  If you become pregnant during the study, stop using the test products and 
call/inform the Investigator at once. 
 
You cannot be in the study if you are breastfeeding.  It is not known whether the test products are safe for 
breast fed babies.  Therefore if you are breastfeeding a child then it may not be safe for you to participate 
in the study.   
 
POSSIBLE BENEFITS OF THE STUDY 
 
You will not get any medical benefit from being in this study, and there is no promise that your condition 
(acne) will get better.  It might stay the same or it might get worse.  Your participation will provide 
information that may help others. There may be other marketed products that claim to have similar 
benefits. 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
Page 6 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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OTHER OPTIONS TO PARTICIPATING IN THE STUDY   
 
Since this study is for research only, the only other choice would be not to be in the study. 
 
STUDY AND TEST PRODUCT CONFIDENTIALITY 
 
To participate in this study, you must agree to keep any information relating to the design, identity or use 
of these test product samples confidential.  
 
On rare occasions, the sponsor may allow the testing company to disclose to you the name of the test 
products if you are not given this information during the study. This information is typically not provided 
until the end of the study or after the test products have been released for sale to the public. The study 
doctor or study staff will notify you if the sponsor allows us to give you this information. 
 
DISCLOSURE AGREEMENT 
 
This section explains how personal health information collected about you for the study may be used.  
Your personal health information includes, but is not limited to, information that was collected for your 
entry into the study and information that is collected during the study.  The purpose of collecting this 
information is to allow the study staff and the Investigator to conduct the study, to evaluate the sponsor’s 
study products and to analyze the study results.   
 
You may decide not to give permission for the release of your personal health information for the study.  
In that case, you will not be able to participate in the study.   This is because the study staff and/or the 
Investigator would not be able to collect the information needed to evaluate the sponsor’s study products. 
 
People who may inspect your personal and health information includes the Investigator, the Institutional 
Review Board, IntegReview IRB, FDA and other regulatory authorities from the United States or other 
countries, the study sponsor and people that work with the sponsor which includes, monitoring 
committees, contract research organizations, and consultants who have contracts with the company to do 
the study and review the study results. These reviews are done to check on the quality of the study and 
also for other purposes allowed by law. 
 
The results of the study may be published in a medical book or journal, or presented at meetings for 
educational purposes.  Neither your name, nor any other personal health information that specifically 
identifies you, will be used in those materials or presentations.    
 
You may ask the Investigator to see and copy your personal health information related to the study.  You 
may also ask the Investigator to correct any study related information about you that is wrong.  You may 
have to wait until the end of the study to see your study records, so that the study can be organized 
properly.   
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
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APPROVED BY 
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SEPTEMBER 16, 2016 
 
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This permission to share your personal health information for this study does not have an expiration date.  
If you no longer want to share your personal health information, you may cancel your permission at any 
time by writing to the study staff and/or the Investigator at the address below: 
 
Thomas J. Stephens & Associates, Inc. 
1801 North Glenville Drive, Suite 200 
Richardson, TX  75081 
 
If you cancel your permission after you have started in the study, the study staff and the Investigator will 
stop collecting your personal health information.  Although they will stop collecting new information 
about you, they will need to use the information they have already collected to evaluate the study results.  
If you start the study and then cancel your permission, you will not be able to continue to participate in 
the study.  This is because the study staff and/or the Investigator would not be able to collect the 
information needed to evaluate the study.  
 
Thomas J. Stephens & Associates and the sponsor will make every effort to keep your personal health 
information private.  But after the study staff or the Investigator share your personal health information 
from the study, federal privacy laws may not keep it private.  There might be laws in your state or other 
federal laws that would protect the privacy of this information. 
 
CONFIDENTIALITY  
 
Your records of being in this study will be kept private except when ordered by law.    The following 
people will have access to your study records: 
 
• 
The Investigator 
• 
Sponsor company or research institution [including monitor(s) and auditor(s)] 
• 
Other country, state or federal regulatory agencies 
• 
IntegReview IRB 
 
The Institutional Review Board (IRB), IntegReview, and accrediting agencies may inspect and copy your 
records, which may have your name on them.  Therefore, total confidentiality cannot be guaranteed.  If 
the study results are presented at meetings or printed in publications, your name will not be used. 
  
IN CASE OF STUDY RELATED INJURY 
 
Side effects or complications, both foreseeable and unforeseeable, are possible in any research study 
without any fault to you, the Investigator, the study site, or the study sponsor. If you get hurt or sick as a 
direct result of being in this study, the sponsor will pay the costs of reasonable medical treatment.  To ask 
questions about this, talk to the Investigator or study staff.   
 
The sponsor’s policy does not offer compensation for other expenses.  Be aware that your health care 
payer/insurer might not cover the costs of study-related injuries or illnesses. 
 
Unreimbursed medical expenses not covered by insurance or other third party coverage will be 
reimbursed by the sponsor for medical treatment for any injury that, in the opinion of the study doctor and 
the sponsor, is directly caused by the investigational product or by procedures required by the study 
protocol which would not have been performed as part of your regular medical care. 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
Page 8 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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LEGAL RIGHTS 
 
You will not lose any of your legal rights by signing this consent form. 
 
CONTACT INFORMATION 
 
If you have questions, concerns, or complaints about this study or to report a study related injury, contact: 
 
Lily Jiang, Ph.D. 
972-392-1529 daytime telephone number  
469-766-4781 after hours number 
 
If you are unable to reach anyone at the number(s) listed above and you need medical attention, 
please go to the nearest emergency room. 
 
If you do not want to talk to the Investigator or study staff, if you have concerns or complaints about the 
research, or to ask questions about your rights as a study subject you may contact IntegReview.  
IntegReview’s policy indicates that all concerns/complaints are to be submitted in writing for review at a 
convened IRB meeting to: 
 
Mailing Address:            OR            Email Address: 
Chairperson 
IntegReview IRB 
3815 S. Capital of Texas Highway 
Suite 320 
Austin, TX  78704 
integreview@integreview.com 
 
If you are unable to provide your concerns/complaints in writing or if this is an emergency situation 
regarding subject safety, contact our office at: 
 
512-326-3001 or 
toll free at 1-877-562-1589 
between 8 a.m. and 5 p.m. Central Time 
 
IntegReview has approved the information in this consent form and has given approval for the 
Investigator to do the study. This does not mean IntegReview has approved your being in the study.  You 
must consider the information in this consent form for yourself and decide if you want to be in this study. 
 
PAYMENT FOR BEING IN THE STUDY 
 
You may receive up to $575.00 for being in the study. You will be paid per completed visit as follows: 
   
Visit 
Compensation (amount) 
Screening/Baseline (Visit 1) 
$40.00 
Week 1 (Visit 2) 
$60.00 
Week 2 (Visit 3) 
$65.00 
Week 6 (Visit 4) 
$75.00 
Week 12 (Visit 5) 
$90.00 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
Page 9 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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Week 18 (Visit 6) 
$95.00 
Week 24 (Visit 7) 
$150.00 
 
If you choose to leave or are withdrawn from the study for any reason before finishing all visits you will 
be paid for each completed visit.  You will receive payment within 2 weeks of final study visit. 
 
If you do not qualify for any reason, you will be paid $20.00, which will be mailed to you within 2 weeks 
of the baseline study visit. 
 
If you are paid $600.00 or more by Thomas J. Stephens & Associates, Inc. in a calendar year, those 
payments will be reported to the Internal Revenue Service via form 1099-MISC. As required by tax laws, 
if you withhold your social security number, Thomas J. Stephens & Associates, Inc. is required to 
withhold 28% of your payment for tax purposes. In this case a form 1099-MISC will be sent to you 
reporting your withholding. 
 
VOLUNTEERING TO BE IN THE STUDY 
 
It is your choice if you want to be in the study.  No one can force you to be in the study.  You may not 
want to be in this study or you may leave the study at any time without penalty or loss of benefits to 
which you are otherwise entitled.   
 
The Investigator, the sponsor company, or IntegReview may take you out of the study without your 
permission, at any time, for the following reasons: 
 
 
• 
If you do not follow the Investigator’s instructions  
• 
If we find out you should not be in the study 
• 
If the study is stopped 
• 
If it becomes harmful to your health 
 
If you leave the study or if you are taken out of the study, you may be asked to return for a final visit to 
have some end of study evaluations or tests.  If information generated from this study is published or 
presented, your identity will not be revealed.  If you leave the study, no more information about you will 
be collected for this study.  However, all of the information you gave us before you left the study will still 
be used.  
 
NEW FINDINGS 
 
If there is new information or any significant new findings that could relate to your willingness to 
continue participation we will tell you.  You can then decide if you still want to be in the study.   
 
THE REASON FOR INSTITUTIONAL REVIEW BOARDS AND INFORMED CONSENT 
 
What is a consent form? 
The informed consent document contains information required by federal regulations.  The informed 
consent document must be approved by an Institutional Review Board (IRB). 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
Page 10 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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What is an Institutional Review Board (IRB)? 
An Institutional Review Board (IRB) is a group of people that reviews research studies.  The main goal of 
this review is to protect the rights and well being of the human subjects participating in research studies. 
 
IntegReview, the IRB for this study 
IntegReview is an IRB whose board members provide IRB services across the United States, Canada, 
Japan and Latin America. 
 
To meet requirements of the law, the IntegReview Boards currently include:  
 
• 
Doctors  
• 
Pharmacists  
• 
Nurses  
• 
Toxicologists (people who study the harmful effects of chemicals)  
• 
Other specialists 
• 
Others who do not have a background in science/medicine 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
Page 11 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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AGREEMENT TO BE IN THE STUDY 
 
This consent form contains important information to help you decide if you want to be in the study.  If 
you have any questions that are not answered in this consent form, ask one of the study staff.  
 
Please answer YES or NO to the following questions: 
 
A. 
Is this document in a language you understand?  
 
 
 
 
 
 
 
B. 
Do you understand the information in this consent form?  
 
 
 
 
 
 
C. 
Have you been given enough time to ask questions and talk about the study? 
 
 
 
 
D. 
Have all of your questions been answered to your satisfaction? 
 
 
 
 
 
 
E. 
Do you think you received enough information about the study?  
 
 
 
 
 
F. 
Do you volunteer to be in this study of your own free will and without being  
pressured by the Investigator or study staff? 
 
 
 
 
 
 
 
 
G. 
Do you know that you can leave the study at any time without giving 
a reason and without affecting your health care?  
 
 
 
 
 
 
 
H. 
Do you know that your health records from this study may be reviewed 
by the sponsor company and by government authorities?  
 
 
 
 
 
 
I. 
Do you know that you cannot be in another study while you are in this study? 
 
 
 
 
IF YOU ANSWERED “NO” TO ANY OF THE ABOVE QUESTIONS, 
OR YOU ARE UNABLE TO ANSWER ANY OF THE ABOVE QUESTIONS, 
YOU SHOULD NOT SIGN THIS CONSENT FORM. 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
  
 
 
 
 
 
 
 
 
 
 
Printed Name of Person Explaining Consent Form 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Person Explaining Consent Form 
 
 
 
 
 
Date 
 
 
 
You will be given a signed and dated copy of this consent form to keep. 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
Page 12 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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Authorization and Release Form 
 
I hereby for good and valuable consideration grant to Thomas J. Stephens & Associates, the study 
sponsor and their respective affiliates, agencies, agents, employees, and assigns (collectively, “Authorized 
Entities”), the unrestricted, royalty free, irrevocable and perpetual right and permission to reproduce, 
distribute, broadcast and/or otherwise use for advertising and other commercial/noncommercial purposes:  
(i) my name, likeness, image, video, and any other biographical or personal information (“Personal 
Content”); and (ii) any statement or endorsement, or any portions thereof (“Testimonial(s)”), made by me 
relating to the study sponsor’s products (“Products”), in any and all media now known or later developed, 
worldwide in perpetuity, without further compensation or approval by me.     
 
I hereby assign to the Authorized Entities all of my world-wide right, title and interest, including my 
copyright interests and all renewals, reissues and extensions thereof, in and to the Personal Content and 
Testimonial(s), including without limitation, any photographic portraits, sound recordings and video 
performances of and/or by me in connection with the Personal Content and/or Testimonial(s).    
  
I am at least 21 years of age, and competent to contract in my own name.  I have read and understand this 
Authorization and Release. 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Person Explaining Release Form 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Person Explaining Release Form 
 
 
 
 
 
Date  
 
 
 
Copy of consent form given to subject on ______________ (date) by ______________ (initials) 
 
You will be given a signed and dated copy of this consent form to keep. 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
Page 13 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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AUTHORIZATION TO USE AND DISCLOSE PERSONAL HEALTH INFORMATION FOR 
RESEARCH 
  
THIS SECTION DESCRIBES YOUR RIGHTS AND HOW PERSONAL HEALTH INFORMATION 
COLLECTED ABOUT YOU DURING THIS STUDY MAY BE USED AND DISCLOSED AND HOW 
YOU CAN GET ACCESS TO THIS INFORMATION.  PLEASE REVIEW IT CAREFULLY. 
  
The United States government has issued a privacy rule to protect the privacy rights of patients.  This rule 
was issued under a law called the Health Insurance Portability and Accountability Act of 1996 
(HIPAA).  The Privacy Rule is designed to protect the confidentiality of your personal health 
information.  The document you are reading, called an “Authorization,” describes your rights and 
explains how your health information will be used and disclosed (shared). 
  
Federal law requires hospitals, researchers and health care providers to protect the privacy of information 
that identifies you and relates to your past, present and future physical and mental health or conditions. 
  
All information collected during the study will be retained by the study doctor and the Study Sponsor, 
except as required by law.  Information from this study will be given to the sponsor.  “Sponsor” includes 
any persons or companies, which are contracted by the sponsor to have access to the research information 
during and after the study.  The information will also be given to the U.S. Food and Drug Administration 
(FDA).  Study records which identify you and the consent form signed by you will be inspected and/or 
copied for research or regulatory purposes by: 
  
• 
Sponsor  
• 
Agents for the sponsor 
• 
The US Food and Drug Administration (FDA) 
• 
Department of Health and Human Services (DHHS) agencies 
• 
IntegReview IRB  
  
Because of the need to release information to these parties, absolute confidentiality cannot be 
guaranteed.  The results of this research study may be presented at meetings or in publications; however, 
your identity will not be disclosed in those presentations. 
  
For purposes of study reporting, you will be identified by your initials and code numbers only.  However, 
your name, date of birth, address, and phone number will be kept on record by the study doctor in case 
you need to be contacted in the future about this study. 
  
After your personal health information is disclosed to the Study Sponsor, the results of the study may be 
reanalyzed at a later date and may be combined with the results of other studies.   The Study Sponsor and 
people who work with the Study Sponsor may use the results of this study for other research purposes, 
including:  
  
• 
Developing a better understanding of the disease; 
• 
Improving the design of future actual use trials 
  
After the study staff or the study doctor discloses your personal health information to others, it could be 
re-disclosed and no longer protected by federal privacy laws. 
  


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
Page 14 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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This permission to share your personal health information for this study does not have an expiration 
date.  If you do not withdraw this Authorization in writing, it will remain in effect indefinitely. Your 
study doctor will keep this Authorization for at least 6 years.  If you no longer want to share your personal 
health information, you may cancel your permission at any time by writing to the study staff and/or the 
study doctor at the address below: 
 
Thomas J. Stephens & Associates, Inc. 
1801 North Glenville Drive, Suite 200 
Richardson, TX  75081 
 
You have the right to see and get a copy of your records related to the study for as long as the study 
doctor has this information.  However, by signing this Authorization you agree that you might not be able 
to review or receive some of your records related to the study until after the study has been completed. 
  
If you cancel your permission after you have started in the study, the study staff and the study doctor will 
stop collecting your personal health information unless the information concerns an adverse event (a bad 
effect) related to the study.  If an adverse event occurs, your entire medical record may be reviewed.  All 
information that has already been collected for study purposes, and any new information about an adverse 
event related to the study, will be sent to the study sponsor.  Although they will stop collecting new 
information about you, they will need to use the information they have already collected to evaluate the 
study results.  If you start the study and then cancel your permission, you will not be able to continue to 
participate in the study.  This is because the study staff and/or the study doctor would not be able to 
collect the information needed to evaluate the study results. 
  
If you withdraw from the study but do not withdraw your Authorization, new personal health information 
may be collected until this study ends.  
  
You may decide not to give permission for the release of your personal health information for this 
study.  In that case, you will not be able to participate.  This is because the study staff and study doctor 
would not be able to collect the information needed to evaluate the study results. 
  
At the completion of the study, you have the right to access your protected health information that is 
created during this research study that relates to your treatment or to payment, provided such information 
is not exempted under certain laws and regulations.  To request this information, please contact the study 
doctor at the address listed above. 
  
Your Right to Access Health Information 
 
Subject to certain exceptions prescribed by law, you have a right to request access to the health 
information that we hold about you and to request changes if your health information is incorrect or 
incomplete. Any request for access or corrections should be made to the principal doctor conducting this 
study. 
 
Your records obtained while you are in this trial, as well as related health records, will remain strictly 
confidential at all times.  However, these will need to be made available to others working on the 
Sponsor’s behalf, the Independent Ethics Committee members and Medicines Regulatory Authorities. 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Lily Jiang, Ph.D. 
Informed Consent 
 
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APPROVED BY 
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SEPTEMBER 16, 2016 
 
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By signing the consent form you agree to this access for the current trial and any further research that may 
be done.  However, the Sponsor will take steps to protect your personal information and will not include 
your name on any sponsor forms, reports, publications, or in any future disclosures.  If you withdraw 
from the study, we will no longer collect your personal information, but we may need to continue to use 
information already collected. 
 
Personal data which may be sensitive (e.g., date of birth) will be collected and processed, but only for 
research purposes in connection with this trial. 
 
The trial data will be sent around the world, but you will not be referred to by name or identified in any 
report or publication nor could the data be traced back to you.  Your data may be transferred to a country 
that does not have the same level of personal data protection as within the United States.  However, 
The Sponsor maintains high standards of confidentiality and protection. 
 
The Sponsor (who will control the use of the data) will take steps to ensure your personal data is 
protected. 
 
By taking part in this trial you agree not to restrict the use of any data even if you withdraw from the trial 
and agree to the transfer of your personal data to other Sponsor companies and to Medicines Regulatory 
Authorities both within and outside of Europe. 
 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
 


APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 29, 2016 
 
INFORMED CONSENT DOCUMENT 
AGREEMENT TO BE IN A RESEARCH STUDY 
 
NAME OF TESTING COMPANY: 
Thomas J. Stephens & Associates, Inc.  
 
NUMBER AND TITLE OF STUDY: 
C16-CD020 (GLI.04.SPR.US10354); “A Multi-
Center Clinical Trial to Evaluate the Efficacy of 
Two Acne Treatments” 
NAME OF PERSON IN CHARGE OF  
THE RESEARCH STUDY 
 (STUDY DOCTOR/INVESTIGATOR): 
Kun Qian, M.D. 
 
TELEPHONE NUMBER(S), DAYTIME: 
 
719-637-2828 
AFTER HOURS:   
 
 
 
 
719-471-1763 
 
 
INTRODUCTION 
 
You are being invited to volunteer for a clinical research study.  You must read and sign this form before 
you agree to take part in this study.  This form will give you more information about this study.  Please ask 
as many questions as you need to before you decide if you want to be in the study.  You should not sign this 
form if you have any questions that have not been answered. 
 
Thomas J. Stephens & Associates, Inc., a contract research organization, is being paid by the sponsor (the 
company paying for this study) to conduct this research study.   
 
You must be honest with the Investigator about your health history or it may not be safe for you to be in this 
study. 
 
PURPOSE OF THE STUDY 
 
The purpose of this study is to evaluate the efficiency of 2 acne treatments for 24 weeks of use in adult 
men and women with mild to moderate facial acne, at least 5 inflammatory lesions, and at least 10 – 100 
non-inflammatory lesions. 
 
HOW LONG THE STUDY WILL LAST AND HOW MANY PEOPLE WILL BE IN THE STUDY 
 
This study will last 24 weeks and have up to 8 visits. At least 100 subjects, men and women between the 
ages of 21-45, are expected to complete this study, with at least 50 subjects completed per cell. Each site 
is to enroll no more than 40 subjects, with at least 100 subjects expected to complete when combined. 
 
TO BE IN THIS STUDY 
 
You must: 
 
• 
Be a man or woman age 21 to 45 years at the time of enrollment. 
• 
Have mild to moderate acne on the face as determined by the Investigator or designee. 
• 
Have at least 5 inflammatory lesions as determined by the Investigator or designee. 
• 
Have 10 – 100 non-inflammatory lesions as determined by the Investigator or designee. 
• 
Be willing to use the test products as instructed for 24 weeks.  
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 2 of 15 
APPROVED BY 
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FEBRUARY 29, 2016 
 
• 
Be willing and able to comply with all of the time commitments and procedural requirements of the 
clinical trial protocol. 
• 
Be willing to provide written informed consent including photo release, Health Insurance Portability 
and Accountability Act (HIPAA), and be able to read, speak, write, understand English and be willing 
to share personal information and data, as verified by signing a written authorization at the screening. 
• 
Be willing to withhold all facial treatments during the course of the study including botulinum toxin, 
injectable fillers, microdermabrasion, IPL, peels, facials, laser treatments and tightening treatments.  
Waxing and threading is allowed but not facial laser hair removal. 
• 
Males must be regular shavers and willing to shave on the day of the study visits (prior to clinic 
visits). 
• 
Women of child bearing potential must be willing to take a urine pregnancy test prior to study 
enrollment, at week 24, and when deemed appropriate by the Investigator and/or Sponsor. 
• 
Individuals of child bearing potential must use an acceptable method of contraception throughout the 
study.  Acceptable methods of birth control include: 
o Oral and other system contraceptives. Individuals must be on a stable use for 3 
months prior to study enrollment. Individuals on oral contraceptives must not alter 
their use, including dose or regimen for the duration of the study 
o Double barrier 
o Bilateral tubal ligation (tubes tied) 
o Partner vasectomy 
o Abstinence 
• 
Be willing to follow study requirements and report any changes in health status or medications, side 
effect symptoms, or reactions immediately. 
• 
Be stable on any medication you are taking for at least 30 days 
 
YOU CANNOT BE ON THE STUDY 
 
If you: 
 
• 
Have been diagnosed with allergies to topical acne products. 
• 
Have a condition and/or disease of the skin that the Investigator deems inappropriate for participation. 
• 
Are a woman who is breastfeeding, pregnant, or planning to become pregnant during the study. 
• 
Have pre-existing or dormant dermatologic conditions on the face (e.g., psoriasis, rosacea, eczema, 
seborrheic dermatitis, severe excoriations etc.) which in the opinion of the Investigator could interfere 
with the outcome of the study. 
• 
Have a history of immunosuppression/immune deficiency disorders (including HIV infection or 
AIDS) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, 
cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, 
Remicade, Stelara.).  
• 
Have an uncontrolled disease such as asthma, diabetes, hypertension, hyperthyroidism, or 
hypothyroidism. Individuals having multiple health conditions may be excluded from participation 
even if the conditions are controlled by diet, medication, etc. at the Investigator’s discretion. 
• 
Are currently participating in another facial usage study or have participated in a clinical trial within 4 
weeks prior to inclusion into the study. 
• 
Have a history of skin cancer on the face within the past 5 years. 
• 
Have any planned surgeries and/or invasive medical procedures during the course of the study. 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 3 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 29, 2016 
 
• 
Have started hormone replacement therapies (HRT) or hormones for birth control less than 3 months 
prior to study entry or plan on starting, stopping, or changing doses of HRT or hormones for birth 
control during the study. 
• 
Have facial sunburn or excessive tanned facial skin or are not willing to avoid daily sun exposure on 
the face and the use of tanning beds or sunless tanning products for the duration of the study. 
• 
Have severe acne, acne conglobata, multiple nodules or cysts (more than 2). 
• 
Are currently taking a natural or prescription testosterone blocker (e.g. saw palmetto, blask cohosh, 
chaste tree, chasteberry, spironolactone, drospirenone, progestins). 
• 
Are currently on a testosterone booster or prescription testosterone (e.g. DHEA, tribulus, testosterone 
cypionate, testosterone enanthate, Sustanon, testosterone propionate, testosterone phenylpropriate, 
Omnadren etc.). 
• 
Are currently taking or have taken within the last 30 days oral or topical prescription medications for 
acne such as Doxycycline, Minocycline, Clindamycin, Bactrim, Tetracycline, Erythromycin, 
Vibramycin and topical tretinoin (Retin A, Renova, Adapalene, Tazarotene), Azelaic acid, benzoyl 
peroxide, Dapsone, Sodium sulfacetamide, Differin, Epiduo. 
• 
Have used oral isotretinoin (Accutane) within the past 6-months. 
• 
Are routinely using (3x a week or more) topical over-the-counter (OTC) acne product (e.g. benzoyl 
peroxide, salicylic acid, alpha hydroxyl, beta hydroxyl and/or poly-hydroxy products or medicated 
cleansers, wipes, masks, scrubs, gels and creams) within 14 days of the study entry. 
• 
Are using or have used any systemic medication considered to affect the course of acne, specifically, 
but not exclusively antibiotics or steroids within the last 30 days prior to entry into the study. 
• 
Have excessive facial hair, including beard, mustache or goatee, or scars, which could interfere with 
evaluations as determined by the Investigator or designee. 
 
WHAT WILL HAPPEN DURING THE STUDY 
 
*Visit 1: Screening (* Visit 1 {Screening} AND Visit 2 {Baseline} may be combined into 1 Visit) 
 
You will: 
 
• 
Be given an IRB-approved Informed Consent Form (ICF), to read and sign. You will be given enough 
time to read the informed consent, and ask questions about the study, and sign 2 copies of this consent 
form. (1 for clinic records, 1 for your records) 
• 
Be given an eligibility and health questionnaire to complete, and assigned a screening number. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Will be screened by the Investigator or designee to see if you qualify for the study. 
• 
If you do qualify for the study, you will: 
o Take a urine pregnancy test (females of child-bearing potential) 
o Have a dermatologist confirm your eligibility 
o Schedule your next appointment. 
 
*Visit 2: Baseline 
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Be screened by the Investigator or designee to see if you still qualify for the study. 
• 
Have your health and eligibility re-reviewed. 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 4 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 29, 2016 
 
• 
If you still qualify for the study you will: 
o Be assigned a subject number 
o Have photos taken of your face 
o Be randomly assigned to receive one of the test products & supporting facial cleanser, 
moisturizer & facial SPF 30  
o Be provided verbal and written usage instructions, and a daily diary to record product use 
o Schedule your next appointment 
 
 
Visits 3, 4 (Week 1, Week 2)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and returned to you. At week 2, your diary 
will be retained by the testing facility and you will be given a new diary 
• 
Have your product collected, weighed, and returned to you 
• 
Schedule your next appointment 
 
Visits 5, 6 (Week 6, Week 12)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Have photos taken of your face 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility and you 
will be given a new diary. 
• 
Have your product collected, weighed, and retained. New products will be dispensed as necessary. 
• 
Schedule your next appointment 
 
Visit 7 (Week 18)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility and you 
will be given a new diary. 
• 
Have your product collected, weighed, and returned to you 
• 
Schedule your next appointment 
 
Visit 8 (Week 24)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Take a urine pregnancy test (females of child-bearing potential). 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Have photos taken of your face 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility. 
• 
Have your product collected, weighed, and retained by the testing facility. 
 
Do not give the study product to other people and keep it out of the reach of children. 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 5 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 29, 2016 
 
RISKS OR DISCOMFORTS 
 
If you do not understand what any of these side effects mean, please ask the investigator or study staff to 
explain these terms to you.  
 
Because the study products are investigational, all of their side effects may not be known.  There may be 
rare and unknown side effects. Some of these may be life threatening. 
 
Possible risks associated with the product are, as with any other cosmetic and OTC products, signs of 
irritation including:  
 
• 
Itching 
• 
Burning 
• 
Stinging 
• 
Rash or other allergic reaction 
• 
Tingling 
• 
Scaling/Dryness 
• 
Redness 
 
In some cases, it is possible for a subject to develop allergic reactions to the test material(s). This risk is 
increased for individuals with a history of allergies, and individuals with asthma and/or a history of hives 
may also be affected. Symptoms include rash, hives, and itching. 
 
You must tell the Investigator or study staff about all side effects that you have. If you are not honest 
about your side effects, it may not be safe for you to stay in the study. 
 
BIRTH CONTROL, DANGERS OF PREGNANCY AND BREASTFEEDING 
 
If you are a female, you must not get pregnant while in this study. The only certain way to not get 
pregnant is to not have sex.  If you are a female and choose to have sex, you must use a type of birth 
control.   
 
Even if you use birth control during the study, there is a chance you could become pregnant.  If you are 
pregnant or become pregnant during the study, test products or procedures may involve unforeseeable 
risks to the unborn baby. 
 
A pregnancy test can be wrong.  If you become pregnant during the study, stop using the test products and 
call/inform the Investigator at once. 
 
You cannot be in the study if you are breastfeeding.  It is not known whether the test products are safe for 
breast fed babies.  Therefore if you are breastfeeding a child then it may not be safe for you to participate 
in the study.   
 
POSSIBLE BENEFITS OF THE STUDY 
 
You will not get any medical benefit from being in this study, and there is no promise that your condition 
(acne) will get better.  It might stay the same or it might get worse.  Your participation will provide 
information that may help others. There may be other marketed products that claim to have similar 
benefits. 
 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 6 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 29, 2016 
 
OTHER OPTIONS TO PARTICIPATING IN THE STUDY   
 
Since this study is for research only, the only other choice would be not to be in the study. 
 
STUDY AND TEST PRODUCT CONFIDENTIALITY 
 
To participate in this study, you must agree to keep any information relating to the design, identity or use 
of these test product samples confidential.  
 
On rare occasions, the sponsor may allow the testing company to disclose to you the name of the test 
products if you are not given this information during the study. This information is typically not provided 
until the end of the study or after the test products have been released for sale to the public. The study 
doctor or study staff will notify you if the sponsor allows us to give you this information. 
 
DISCLOSURE AGREEMENT 
 
This section explains how personal health information collected about you for the study may be used.  
Your personal health information includes, but is not limited to, information that was collected for your 
entry into the study and information that is collected during the study.  The purpose of collecting this 
information is to allow the study staff and the Investigator to conduct the study, to evaluate the sponsor’s 
study products and to analyze the study results.   
 
You may decide not to give permission for the release of your personal health information for the study.  
In that case, you will not be able to participate in the study.   This is because the study staff and/or the 
Investigator would not be able to collect the information needed to evaluate the sponsor’s study products. 
 
People who may inspect your personal and health information includes the Investigator, the Institutional 
Review Board, IntegReview IRB, FDA and other regulatory authorities from the United States or other 
countries, the study sponsor and people that work with the sponsor which includes, monitoring 
committees, contract research organizations, and consultants who have contracts with the company to do 
the study and review the study results. These reviews are done to check on the quality of the study and 
also for other purposes allowed by law. 
 
The results of the study may be published in a medical book or journal, or presented at meetings for 
educational purposes.  Neither your name, nor any other personal health information that specifically 
identifies you, will be used in those materials or presentations.    
 
You may ask the Investigator to see and copy your personal health information related to the study.  You 
may also ask the Investigator to correct any study related information about you that is wrong.  You may 
have to wait until the end of the study to see your study records, so that the study can be organized 
properly.   
 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 7 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 29, 2016 
 
This permission to share your personal health information for this study does not have an expiration date.  
If you no longer want to share your personal health information, you may cancel your permission at any 
time by writing to the study staff and/or the Investigator at the address below: 
 
Thomas J. Stephens & Associates, Inc. 
5050 Edison Ave., Suite 202 
Colorado Springs, CO  80915 
 
If you cancel your permission after you have started in the study, the study staff and the Investigator will 
stop collecting your personal health information.  Although they will stop collecting new information 
about you, they will need to use the information they have already collected to evaluate the study results.  
If you start the study and then cancel your permission, you will not be able to continue to participate in 
the study.  This is because the study staff and/or the Investigator would not be able to collect the 
information needed to evaluate the study.  
 
Thomas J. Stephens & Associates and the sponsor will make every effort to keep your personal health 
information private.  But after the study staff or the Investigator share your personal health information 
from the study, federal privacy laws may not keep it private.  There might be laws in your state or other 
federal laws that would protect the privacy of this information. 
 
CONFIDENTIALITY  
 
Your records of being in this study will be kept private except when ordered by law.    The following 
people will have access to your study records: 
 
• 
The Investigator 
• 
Sponsor company or research institution [including monitor(s) and auditor(s)] 
• 
Other country, state or federal regulatory agencies 
• 
IntegReview IRB 
 
The Institutional Review Board (IRB), IntegReview, and accrediting agencies may inspect and copy your 
records, which may have your name on them.  Therefore, total confidentiality cannot be guaranteed.  If 
the study results are presented at meetings or printed in publications, your name will not be used. 
  
IN CASE OF STUDY RELATED INJURY 
 
Side effects or complications, both foreseeable and unforeseeable, are possible in any research study 
without any fault to you, the Investigator, the study site, or the study sponsor. If you get hurt or sick as a 
direct result of being in this study, the sponsor will pay the costs of reasonable medical treatment.  To ask 
questions about this, talk to the Investigator or study staff.   
 
The sponsor’s policy does not offer compensation for other expenses.  Be aware that your health care 
payer/insurer might not cover the costs of study-related injuries or illnesses. 
 
Unreimbursed medical expenses not covered by insurance or other third party coverage will be 
reimbursed by the sponsor for medical treatment for any injury that, in the opinion of the study doctor and 
the sponsor, is directly caused by the investigational product or by procedures required by the study 
protocol which would not have been performed as part of your regular medical care. 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 8 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 29, 2016 
 
LEGAL RIGHTS 
 
You will not lose any of your legal rights by signing this consent form. 
 
CONTACT INFORMATION 
 
If you have questions, concerns, or complaints about this study or to report a study related injury, contact: 
 
Kun Qian, M.D. 
719-637-2828 daytime telephone number  
719-471-1763 after hours number 
 
If you are unable to reach anyone at the number(s) listed above and you need medical attention, 
please go to the nearest emergency room. 
 
If you do not want to talk to the Investigator or study staff, if you have concerns or complaints about the 
research, or to ask questions about your rights as a study subject you may contact IntegReview.  
IntegReview’s policy indicates that all concerns/complaints are to be submitted in writing for review at a 
convened IRB meeting to: 
 
Mailing Address:            OR            Email Address: 
Chairperson 
IntegReview IRB 
3815 S. Capital of Texas Highway 
Suite 320 
Austin, TX  78704 
integreview@integreview.com 
 
If you are unable to provide your concerns/complaints in writing or if this is an emergency situation 
regarding subject safety, contact our office at: 
 
512-326-3001 or 
toll free at 1-877-562-1589 
between 8 a.m. and 5 p.m. Central Time 
 
IntegReview has approved the information in this consent form and has given approval for the 
Investigator to do the study. This does not mean IntegReview has approved your being in the study.  You 
must consider the information in this consent form for yourself and decide if you want to be in this study. 
 
PAYMENT FOR BEING IN THE STUDY 
 
You may receive up to $575.00 for being in the study. You will be paid per completed visit as follows: 
   
Visit 
Compensation (amount) 
Visit 1 
$40.00 
Visit 2 
$60.00 
Visit 3 
$65.00 
Visit 4 
$75.00 
Visit 5 
$90.00 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 9 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 29, 2016 
 
Visit 6 
$95.00 
Visit 7 
$150.00 
 
If you choose to leave or are withdrawn from the study for any reason before finishing all visits you will 
be paid for each completed visit.  You will receive payment within 2 weeks of final study visit. 
 
If you do not qualify for any reason, you will be paid $20.00, which will be mailed to you within 2 weeks 
of the baseline study visit. 
 
If you are paid $600.00 or more by Thomas J. Stephens & Associates, Inc. in a calendar year, those 
payments will be reported to the Internal Revenue Service via form 1099-MISC. As required by tax laws, 
if you withhold your social security number, Thomas J. Stephens & Associates, Inc. is required to 
withhold 28% of your payment for tax purposes. In this case a form 1099-MISC will be sent to you 
reporting your withholding. 
 
VOLUNTEERING TO BE IN THE STUDY 
 
It is your choice if you want to be in the study.  No one can force you to be in the study.  You may not 
want to be in this study or you may leave the study at any time without penalty or loss of benefits to 
which you are otherwise entitled.   
 
The Investigator, the sponsor company, or IntegReview may take you out of the study without your 
permission, at any time, for the following reasons: 
 
 
• 
If you do not follow the Investigator’s instructions  
• 
If we find out you should not be in the study 
• 
If the study is stopped 
• 
If it becomes harmful to your health 
 
If you leave the study or if you are taken out of the study, you may be asked to return for a final visit to 
have some end of study evaluations or tests.  If information generated from this study is published or 
presented, your identity will not be revealed.  If you leave the study, no more information about you will 
be collected for this study.  However, all of the information you gave us before you left the study will still 
be used.  
 
NEW FINDINGS 
 
If there is new information or any significant new findings that could relate to your willingness to 
continue participation we will tell you.  You can then decide if you still want to be in the study.   
 
THE REASON FOR INSTITUTIONAL REVIEW BOARDS AND INFORMED CONSENT 
 
What is a consent form? 
The informed consent document contains information required by federal regulations.  The informed 
consent document must be approved by an Institutional Review Board (IRB). 
 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 10 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 29, 2016 
 
What is an Institutional Review Board (IRB)? 
An Institutional Review Board (IRB) is a group of people that reviews research studies.  The main goal of 
this review is to protect the rights and well being of the human subjects participating in research studies. 
 
IntegReview, the IRB for this study 
IntegReview is an IRB whose board members provide IRB services across the United States, Canada, 
Japan and Latin America. 
 
To meet requirements of the law, the IntegReview Boards currently include:  
 
• 
Doctors  
• 
Pharmacists  
• 
Nurses  
• 
Toxicologists (people who study the harmful effects of chemicals)  
• 
Other specialists 
• 
Others who do not have a background in science/medicine 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 11 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 29, 2016 
 
AGREEMENT TO BE IN THE STUDY 
 
This consent form contains important information to help you decide if you want to be in the study.  If 
you have any questions that are not answered in this consent form, ask one of the study staff.  
 
Please answer YES or NO to the following questions: 
 
A. 
Is this document in a language you understand?  
 
 
 
 
 
 
 
B. 
Do you understand the information in this consent form?  
 
 
 
 
 
 
C. 
Have you been given enough time to ask questions and talk about the study? 
 
 
 
 
D. 
Have all of your questions been answered to your satisfaction? 
 
 
 
 
 
 
E. 
Do you think you received enough information about the study?  
 
 
 
 
 
F. 
Do you volunteer to be in this study of your own free will and without being  
pressured by the Investigator or study staff? 
 
 
 
 
 
 
 
 
G. 
Do you know that you can leave the study at any time without giving 
a reason and without affecting your health care?  
 
 
 
 
 
 
 
H. 
Do you know that your health records from this study may be reviewed 
by the sponsor company and by government authorities?  
 
 
 
 
 
 
I. 
Do you know that you cannot be in another study while you are in this study? 
 
 
 
 
IF YOU ANSWERED “NO” TO ANY OF THE ABOVE QUESTIONS, 
OR YOU ARE UNABLE TO ANSWER ANY OF THE ABOVE QUESTIONS, 
YOU SHOULD NOT SIGN THIS CONSENT FORM. 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
  
 
 
 
 
 
 
 
 
 
 
Printed Name of Person Explaining Consent Form 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Person Explaining Consent Form 
 
 
 
 
 
Date 
 
 
 
You will be given a signed and dated copy of this consent form to keep. 
 
 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 12 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 29, 2016 
 
Authorization and Release Form 
 
I hereby for good and valuable consideration grant to Thomas J. Stephens & Associates, the study 
sponsor and their respective affiliates, agencies, agents, employees, and assigns (collectively, “Authorized 
Entities”), the unrestricted, royalty free, irrevocable and perpetual right and permission to reproduce, 
distribute, broadcast and/or otherwise use for advertising and other commercial/noncommercial purposes:  
(i) my name, likeness, image, video, and any other biographical or personal information (“Personal 
Content”); and (ii) any statement or endorsement, or any portions thereof (“Testimonial(s)”), made by me 
relating to the study sponsor’s products (“Products”), in any and all media now known or later developed, 
worldwide in perpetuity, without further compensation or approval by me.     
 
I hereby assign to the Authorized Entities all of my world-wide right, title and interest, including my 
copyright interests and all renewals, reissues and extensions thereof, in and to the Personal Content and 
Testimonial(s), including without limitation, any photographic portraits, sound recordings and video 
performances of and/or by me in connection with the Personal Content and/or Testimonial(s).    
  
I am at least 21 years of age, and competent to contract in my own name.  I have read and understand this 
Authorization and Release. 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Person Explaining Release Form 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Person Explaining Release Form 
 
 
 
 
 
Date  
 
 
 
Copy of consent form given to subject on ______________ (date) by ______________ (initials) 
 
You will be given a signed and dated copy of this consent form to keep. 
 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 13 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 29, 2016 
 
AUTHORIZATION TO USE AND DISCLOSE PERSONAL HEALTH INFORMATION FOR 
RESEARCH 
  
THIS SECTION DESCRIBES YOUR RIGHTS AND HOW PERSONAL HEALTH INFORMATION 
COLLECTED ABOUT YOU DURING THIS STUDY MAY BE USED AND DISCLOSED AND HOW 
YOU CAN GET ACCESS TO THIS INFORMATION.  PLEASE REVIEW IT CAREFULLY. 
  
The United States government has issued a privacy rule to protect the privacy rights of patients.  This rule 
was issued under a law called the Health Insurance Portability and Accountability Act of 1996 
(HIPAA).  The Privacy Rule is designed to protect the confidentiality of your personal health 
information.  The document you are reading, called an “Authorization,” describes your rights and 
explains how your health information will be used and disclosed (shared). 
  
Federal law requires hospitals, researchers and health care providers to protect the privacy of information 
that identifies you and relates to your past, present and future physical and mental health or conditions. 
  
All information collected during the study will be retained by the study doctor and the Study Sponsor, 
except as required by law.  Information from this study will be given to the sponsor.  “Sponsor” includes 
any persons or companies, which are contracted by the sponsor to have access to the research information 
during and after the study.  The information will also be given to the U.S. Food and Drug Administration 
(FDA).  Study records which identify you and the consent form signed by you will be inspected and/or 
copied for research or regulatory purposes by: 
  
• 
Sponsor  
• 
Agents for the sponsor 
• 
The US Food and Drug Administration (FDA) 
• 
Department of Health and Human Services (DHHS) agencies 
• 
IntegReview IRB  
  
Because of the need to release information to these parties, absolute confidentiality cannot be 
guaranteed.  The results of this research study may be presented at meetings or in publications; however, 
your identity will not be disclosed in those presentations. 
  
For purposes of study reporting, you will be identified by your initials and code numbers only.  However, 
your name, date of birth, address, and phone number will be kept on record by the study doctor in case 
you need to be contacted in the future about this study. 
  
After your personal health information is disclosed to the Study Sponsor, the results of the study may be 
reanalyzed at a later date and may be combined with the results of other studies.   The Study Sponsor and 
people who work with the Study Sponsor may use the results of this study for other research purposes, 
including:  
  
• 
Developing a better understanding of the disease; 
• 
Improving the design of future actual use trials 
  
After the study staff or the study doctor discloses your personal health information to others, it could be 
re-disclosed and no longer protected by federal privacy laws. 
  
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 14 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 29, 2016 
 
This permission to share your personal health information for this study does not have an expiration 
date.  If you do not withdraw this Authorization in writing, it will remain in effect indefinitely. Your 
study doctor will keep this Authorization for at least 6 years.  If you no longer want to share your personal 
health information, you may cancel your permission at any time by writing to the study staff and/or the 
study doctor at the address below: 
 
Thomas J. Stephens & Associates, Inc. 
5050 Edison Ave., Suite 202 
Colorado Springs, CO  80915 
 
You have the right to see and get a copy of your records related to the study for as long as the study 
doctor has this information.  However, by signing this Authorization you agree that you might not be able 
to review or receive some of your records related to the study until after the study has been completed. 
  
If you cancel your permission after you have started in the study, the study staff and the study doctor will 
stop collecting your personal health information unless the information concerns an adverse event (a bad 
effect) related to the study.  If an adverse event occurs, your entire medical record may be reviewed.  All 
information that has already been collected for study purposes, and any new information about an adverse 
event related to the study, will be sent to the study sponsor.  Although they will stop collecting new 
information about you, they will need to use the information they have already collected to evaluate the 
study results.  If you start the study and then cancel your permission, you will not be able to continue to 
participate in the study.  This is because the study staff and/or the study doctor would not be able to 
collect the information needed to evaluate the study results. 
  
If you withdraw from the study but do not withdraw your Authorization, new personal health information 
may be collected until this study ends.  
  
You may decide not to give permission for the release of your personal health information for this 
study.  In that case, you will not be able to participate.  This is because the study staff and study doctor 
would not be able to collect the information needed to evaluate the study results. 
  
At the completion of the study, you have the right to access your protected health information that is 
created during this research study that relates to your treatment or to payment, provided such information 
is not exempted under certain laws and regulations.  To request this information, please contact the study 
doctor at the address listed above. 
  
Your Right to Access Health Information 
 
Subject to certain exceptions prescribed by law, you have a right to request access to the health 
information that we hold about you and to request changes if your health information is incorrect or 
incomplete. Any request for access or corrections should be made to the principal doctor conducting this 
study. 
 
Your records obtained while you are in this trial, as well as related health records, will remain strictly 
confidential at all times.  However, these will need to be made available to others working on the 
Sponsor’s behalf, the Independent Ethics Committee members and Medicines Regulatory Authorities. 
 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 15 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 29, 2016 
 
By signing the consent form you agree to this access for the current trial and any further research that may 
be done.  However, the Sponsor will take steps to protect your personal information and will not include 
your name on any sponsor forms, reports, publications, or in any future disclosures.  If you withdraw 
from the study, we will no longer collect your personal information, but we may need to continue to use 
information already collected. 
 
Personal data which may be sensitive (e.g., date of birth) will be collected and processed, but only for 
research purposes in connection with this trial. 
 
The trial data will be sent around the world, but you will not be referred to by name or identified in any 
report or publication nor could the data be traced back to you.  Your data may be transferred to a country 
that does not have the same level of personal data protection as within the United States.  However, 
The Sponsor maintains high standards of confidentiality and protection. 
 
The Sponsor (who will control the use of the data) will take steps to ensure your personal data is 
protected. 
 
By taking part in this trial you agree not to restrict the use of any data even if you withdraw from the trial 
and agree to the transfer of your personal data to other Sponsor companies and to Medicines Regulatory 
Authorities both within and outside of Europe. 
 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
 
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APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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INFORMED CONSENT DOCUMENT 
AGREEMENT TO BE IN A RESEARCH STUDY 
 
NAME OF TESTING COMPANY: 
Thomas J. Stephens & Associates, Inc.  
 
NUMBER AND TITLE OF STUDY: 
C16-CD020 (GLI.04.SPR.US10354); “A Multi-
Center Clinical Trial to Evaluate the Efficacy of 
Two Acne Treatments” 
NAME OF PERSON IN CHARGE OF  
THE RESEARCH STUDY 
 (STUDY DOCTOR/INVESTIGATOR): 
Kun Qian, M.D. 
 
TELEPHONE NUMBER(S), DAYTIME: 
 
719-637-2828 
AFTER HOURS:   
 
 
 
 
719-471-1763 
 
 
INTRODUCTION 
 
You are being invited to volunteer for a clinical research study.  You must read and sign this form before 
you agree to take part in this study.  This form will give you more information about this study.  Please ask 
as many questions as you need to before you decide if you want to be in the study.  You should not sign this 
form if you have any questions that have not been answered. 
 
Thomas J. Stephens & Associates, Inc., a contract research organization, is being paid by the sponsor (the 
company paying for this study) to conduct this research study.   
 
You must be honest with the Investigator about your health history or it may not be safe for you to be in this 
study. 
 
PURPOSE OF THE STUDY 
 
The purpose of this study is to evaluate the efficiency of 2 acne treatments for 24 weeks of use in adult 
men and women with mild to moderate facial acne, at least 5 inflammatory lesions, and at least 10 – 100 
non-inflammatory lesions. 
 
HOW LONG THE STUDY WILL LAST AND HOW MANY PEOPLE WILL BE IN THE STUDY 
 
This study will last 24 weeks and have up to 8 visits. At least 100 subjects, men and women between the 
ages of 21-45, are expected to complete this study, with at least 50 subjects completed per cell.  
 
TO BE IN THIS STUDY 
 
You must: 
 
• 
Be a man or woman age 21 to 45 years at the time of enrollment. 
• 
Have mild to moderate acne on the face as determined by the Investigator or designee. 
• 
Have at least 5 inflammatory lesions as determined by the Investigator or designee. 
• 
Have 10 – 100 non-inflammatory lesions as determined by the Investigator or designee. 
• 
Be willing to use the test products as instructed for 24 weeks.  
• 
Be willing and able to comply with all of the time commitments and procedural requirements of the 
clinical trial protocol. 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 2 of 15 
APPROVED BY 
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SEPTEMBER 16, 2016 
 
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• 
Be willing to provide written informed consent including photo release, Health Insurance Portability 
and Accountability Act (HIPAA), and be able to read, speak, write, understand English and be willing 
to share personal information and data, as verified by signing a written authorization at the screening. 
• 
Be willing to withhold all facial treatments during the course of the study including botulinum toxin, 
injectable fillers, microdermabrasion, IPL, peels, facials, laser treatments and tightening treatments.  
Waxing and threading is allowed but not facial laser hair removal. 
• 
Males must be regular shavers and willing to shave on the day of the study visits (prior to clinic 
visits). 
• 
Women of child bearing potential must be willing to take a urine pregnancy test prior to study 
enrollment, at week 24, and when deemed appropriate by the Investigator and/or Sponsor. 
• 
Individuals of child bearing potential must use an acceptable method of contraception throughout the 
study.  Acceptable methods of birth control include: 
o Oral and other system contraceptives. Individuals must be on a stable use for 3 
months prior to study enrollment. Individuals on oral contraceptives must not alter 
their use, including dose or regimen for the duration of the study 
o Double barrier 
o Bilateral tubal ligation (tubes tied) 
o Partner vasectomy 
o Abstinence 
• 
Be willing to follow study requirements and report any changes in health status or medications, side 
effect symptoms, or reactions immediately. 
• 
Be stable on any medication you are taking for at least 30 days 
 
YOU CANNOT BE ON THE STUDY 
 
If you: 
 
• 
Have been diagnosed with allergies to topical acne products. 
• 
Have a condition and/or disease of the skin that the Investigator deems inappropriate for participation. 
• 
Are a woman who is breastfeeding, pregnant, or planning to become pregnant during the study. 
• 
Have pre-existing or dormant dermatologic conditions on the face (e.g., psoriasis, rosacea, eczema, 
seborrheic dermatitis, severe excoriations etc.) which in the opinion of the Investigator could interfere 
with the outcome of the study. 
• 
Have a history of immunosuppression/immune deficiency disorders (including HIV infection or 
AIDS) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, 
cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, 
Remicade, Stelara.).  
• 
Have an uncontrolled disease such as asthma, diabetes, hypertension, hyperthyroidism, or 
hypothyroidism. Individuals having multiple health conditions may be excluded from participation 
even if the conditions are controlled by diet, medication, etc. at the Investigator’s discretion. 
• 
Are currently participating in another facial usage study or have participated in a clinical trial within 4 
weeks prior to inclusion into the study. 
• 
Have a history of skin cancer on the face within the past 5 years. 
• 
Have any planned surgeries and/or invasive medical procedures during the course of the study. 
• 
Have started hormone replacement therapies (HRT) or hormones for birth control less than 3 months 
prior to study entry or plan on starting, stopping, or changing doses of HRT or hormones for birth 
control during the study. 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 3 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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• 
Have facial sunburn or excessive tanned facial skin or are not willing to avoid daily sun exposure on 
the face and the use of tanning beds or sunless tanning products for the duration of the study. 
• 
Have severe acne, acne conglobata, multiple nodules or cysts (more than 2). 
• 
Are currently taking a natural or prescription testosterone blocker (e.g. saw palmetto, blask cohosh, 
chaste tree, chasteberry, spironolactone, drospirenone, progestins). 
• 
Are currently on a testosterone booster or prescription testosterone (e.g. DHEA, tribulus, testosterone 
cypionate, testosterone enanthate, Sustanon, testosterone propionate, testosterone phenylpropriate, 
Omnadren etc.). 
• 
Are currently taking or have taken within the last 30 days oral or topical prescription medications for 
acne such as Doxycycline, Minocycline, Clindamycin, Bactrim, Tetracycline, Erythromycin, 
Vibramycin and topical tretinoin (Retin A, Renova, Adapalene, Tazarotene), Azelaic acid, benzoyl 
peroxide, Dapsone, Sodium sulfacetamide, Differin, Epiduo. 
• 
Have used oral isotretinoin (Accutane) within the past 6-months. 
• 
Are routinely using (3x a week or more) topical over-the-counter (OTC) acne product (e.g. benzoyl 
peroxide, salicylic acid, alpha hydroxyl, beta hydroxyl and/or poly-hydroxy products or medicated 
cleansers, wipes, masks, scrubs, gels and creams) within 14 days of the study entry. 
• 
Are using or have used any systemic medication considered to affect the course of acne, specifically, 
but not exclusively antibiotics or steroids within the last 30 days prior to entry into the study. 
• 
Have excessive facial hair, including beard, mustache or goatee, or scars, which could interfere with 
evaluations as determined by the Investigator or designee. 
 
WHAT WILL HAPPEN DURING THE STUDY 
 
*Visit 1: Screening (* Visit 1 {Screening} AND Visit 2 {Baseline} may be combined into 1 Visit) 
 
You will: 
 
• 
Be given an IRB-approved Informed Consent Form (ICF), to read and sign. You will be given enough 
time to read the informed consent, and ask questions about the study, and sign 2 copies of this consent 
form. (1 for clinic records, 1 for your records) 
• 
Be given an eligibility and health questionnaire to complete, and assigned a screening number. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Will be screened by the Investigator or designee to see if you qualify for the study. 
• 
If you do qualify for the study, you will: 
o Take a urine pregnancy test (females of child-bearing potential) 
o Have a dermatologist confirm your eligibility 
o Schedule your next appointment. 
 
*Visit 2: Baseline 
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Be screened by the Investigator or designee to see if you still qualify for the study. 
• 
Have your health and eligibility re-reviewed. 
• 
If you still qualify for the study you will: 
o Be assigned a subject number 
o Have photos taken of your face 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 4 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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o Be randomly assigned to receive one of the test products & supporting facial cleanser, 
moisturizer & facial SPF 30  
o Be provided verbal and written usage instructions, and a daily diary to record product use 
o Schedule your next appointment 
 
 
Visits 3, 4 (Week 1, Week 2)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and returned to you. At week 2, your diary 
will be retained by the testing facility and you will be given a new diary 
• 
Have your product collected, weighed, and returned to you 
• 
Schedule your next appointment 
 
Visits 5, 6 (Week 6, Week 12)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Have photos taken of your face 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility and you 
will be given a new diary. 
• 
Have your product collected, weighed, and retained. New products will be dispensed as necessary. 
• 
Schedule your next appointment 
 
Visit 7 (Week 18)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility and you 
will be given a new diary. 
• 
Have your product collected, weighed, and returned to you 
• 
Schedule your next appointment 
 
Visit 8 (Week 24)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Take a urine pregnancy test (females of child-bearing potential). 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Have photos taken of your face 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility. 
• 
Have your product collected, weighed, and retained by the testing facility. 
 
Do not give the study product to other people and keep it out of the reach of children. 
 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 5 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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RISKS OR DISCOMFORTS 
 
If you do not understand what any of these side effects mean, please ask the investigator or study staff to 
explain these terms to you.  
 
Because the study products are investigational, all of their side effects may not be known.  There may be 
rare and unknown side effects. Some of these may be life threatening. 
 
Possible risks associated with the product are, as with any other cosmetic and OTC products, signs of 
irritation including:  
 
• 
Itching 
• 
Burning 
• 
Stinging 
• 
Rash or other allergic reaction 
• 
Tingling 
• 
Scaling/Dryness 
• 
Redness 
 
In some cases, it is possible for a subject to develop allergic reactions to the test material(s). This risk is 
increased for individuals with a history of allergies, and individuals with asthma and/or a history of hives 
may also be affected. Symptoms include rash, hives, and itching. 
 
You must tell the Investigator or study staff about all side effects that you have. If you are not honest 
about your side effects, it may not be safe for you to stay in the study. 
 
BIRTH CONTROL, DANGERS OF PREGNANCY AND BREASTFEEDING 
 
If you are a female, you must not get pregnant while in this study. The only certain way to not get 
pregnant is to not have sex.  If you are a female and choose to have sex, you must use a type of birth 
control.   
 
Even if you use birth control during the study, there is a chance you could become pregnant.  If you are 
pregnant or become pregnant during the study, test products or procedures may involve unforeseeable 
risks to the unborn baby. 
 
A pregnancy test can be wrong.  If you become pregnant during the study, stop using the test products and 
call/inform the Investigator at once. 
 
You cannot be in the study if you are breastfeeding.  It is not known whether the test products are safe for 
breast fed babies.  Therefore if you are breastfeeding a child then it may not be safe for you to participate 
in the study.   
 
POSSIBLE BENEFITS OF THE STUDY 
 
You will not get any medical benefit from being in this study, and there is no promise that your condition 
(acne) will get better.  It might stay the same or it might get worse.  Your participation will provide 
information that may help others. There may be other marketed products that claim to have similar 
benefits. 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 6 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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OTHER OPTIONS TO PARTICIPATING IN THE STUDY   
 
Since this study is for research only, the only other choice would be not to be in the study. 
 
STUDY AND TEST PRODUCT CONFIDENTIALITY 
 
To participate in this study, you must agree to keep any information relating to the design, identity or use 
of these test product samples confidential.  
 
On rare occasions, the sponsor may allow the testing company to disclose to you the name of the test 
products if you are not given this information during the study. This information is typically not provided 
until the end of the study or after the test products have been released for sale to the public. The study 
doctor or study staff will notify you if the sponsor allows us to give you this information. 
 
DISCLOSURE AGREEMENT 
 
This section explains how personal health information collected about you for the study may be used.  
Your personal health information includes, but is not limited to, information that was collected for your 
entry into the study and information that is collected during the study.  The purpose of collecting this 
information is to allow the study staff and the Investigator to conduct the study, to evaluate the sponsor’s 
study products and to analyze the study results.   
 
You may decide not to give permission for the release of your personal health information for the study.  
In that case, you will not be able to participate in the study.   This is because the study staff and/or the 
Investigator would not be able to collect the information needed to evaluate the sponsor’s study products. 
 
People who may inspect your personal and health information includes the Investigator, the Institutional 
Review Board, IntegReview IRB, FDA and other regulatory authorities from the United States or other 
countries, the study sponsor and people that work with the sponsor which includes, monitoring 
committees, contract research organizations, and consultants who have contracts with the company to do 
the study and review the study results. These reviews are done to check on the quality of the study and 
also for other purposes allowed by law. 
 
The results of the study may be published in a medical book or journal, or presented at meetings for 
educational purposes.  Neither your name, nor any other personal health information that specifically 
identifies you, will be used in those materials or presentations.    
 
You may ask the Investigator to see and copy your personal health information related to the study.  You 
may also ask the Investigator to correct any study related information about you that is wrong.  You may 
have to wait until the end of the study to see your study records, so that the study can be organized 
properly.   
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 7 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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This permission to share your personal health information for this study does not have an expiration date.  
If you no longer want to share your personal health information, you may cancel your permission at any 
time by writing to the study staff and/or the Investigator at the address below: 
 
Thomas J. Stephens & Associates, Inc. 
5050 Edison Ave., Suite 202 
Colorado Springs, CO  80915 
 
If you cancel your permission after you have started in the study, the study staff and the Investigator will 
stop collecting your personal health information.  Although they will stop collecting new information 
about you, they will need to use the information they have already collected to evaluate the study results.  
If you start the study and then cancel your permission, you will not be able to continue to participate in 
the study.  This is because the study staff and/or the Investigator would not be able to collect the 
information needed to evaluate the study.  
 
Thomas J. Stephens & Associates and the sponsor will make every effort to keep your personal health 
information private.  But after the study staff or the Investigator share your personal health information 
from the study, federal privacy laws may not keep it private.  There might be laws in your state or other 
federal laws that would protect the privacy of this information. 
 
CONFIDENTIALITY  
 
Your records of being in this study will be kept private except when ordered by law.    The following 
people will have access to your study records: 
 
• 
The Investigator 
• 
Sponsor company or research institution [including monitor(s) and auditor(s)] 
• 
Other country, state or federal regulatory agencies 
• 
IntegReview IRB 
 
The Institutional Review Board (IRB), IntegReview, and accrediting agencies may inspect and copy your 
records, which may have your name on them.  Therefore, total confidentiality cannot be guaranteed.  If 
the study results are presented at meetings or printed in publications, your name will not be used. 
  
IN CASE OF STUDY RELATED INJURY 
 
Side effects or complications, both foreseeable and unforeseeable, are possible in any research study 
without any fault to you, the Investigator, the study site, or the study sponsor. If you get hurt or sick as a 
direct result of being in this study, the sponsor will pay the costs of reasonable medical treatment.  To ask 
questions about this, talk to the Investigator or study staff.   
 
The sponsor’s policy does not offer compensation for other expenses.  Be aware that your health care 
payer/insurer might not cover the costs of study-related injuries or illnesses. 
 
Unreimbursed medical expenses not covered by insurance or other third party coverage will be 
reimbursed by the sponsor for medical treatment for any injury that, in the opinion of the study doctor and 
the sponsor, is directly caused by the investigational product or by procedures required by the study 
protocol which would not have been performed as part of your regular medical care. 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 8 of 15 
APPROVED BY 
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SEPTEMBER 16, 2016 
 
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LEGAL RIGHTS 
 
You will not lose any of your legal rights by signing this consent form. 
 
CONTACT INFORMATION 
 
If you have questions, concerns, or complaints about this study or to report a study related injury, contact: 
 
Kun Qian, M.D. 
719-637-2828 daytime telephone number  
719-471-1763 after hours number 
 
If you are unable to reach anyone at the number(s) listed above and you need medical attention, 
please go to the nearest emergency room. 
 
If you do not want to talk to the Investigator or study staff, if you have concerns or complaints about the 
research, or to ask questions about your rights as a study subject you may contact IntegReview.  
IntegReview’s policy indicates that all concerns/complaints are to be submitted in writing for review at a 
convened IRB meeting to: 
 
Mailing Address:            OR            Email Address: 
Chairperson 
IntegReview IRB 
3815 S. Capital of Texas Highway 
Suite 320 
Austin, TX  78704 
integreview@integreview.com 
 
If you are unable to provide your concerns/complaints in writing or if this is an emergency situation 
regarding subject safety, contact our office at: 
 
512-326-3001 or 
toll free at 1-877-562-1589 
between 8 a.m. and 5 p.m. Central Time 
 
IntegReview has approved the information in this consent form and has given approval for the 
Investigator to do the study. This does not mean IntegReview has approved your being in the study.  You 
must consider the information in this consent form for yourself and decide if you want to be in this study. 
 
PAYMENT FOR BEING IN THE STUDY 
 
You may receive up to $575.00 for being in the study. You will be paid per completed visit as follows: 
   
Visit 
Compensation (amount) 
Visit 1 
$40.00 
Visit 2 
$60.00 
Visit 3 
$65.00 
Visit 4 
$75.00 
Visit 5 
$90.00 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
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APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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Visit 6 
$95.00 
Visit 7 
$150.00 
 
If you choose to leave or are withdrawn from the study for any reason before finishing all visits you will 
be paid for each completed visit.  You will receive payment within 2 weeks of final study visit. 
 
If you do not qualify for any reason, you will be paid $20.00, which will be mailed to you within 2 weeks 
of the baseline study visit. 
 
If you are paid $600.00 or more by Thomas J. Stephens & Associates, Inc. in a calendar year, those 
payments will be reported to the Internal Revenue Service via form 1099-MISC. As required by tax laws, 
if you withhold your social security number, Thomas J. Stephens & Associates, Inc. is required to 
withhold 28% of your payment for tax purposes. In this case a form 1099-MISC will be sent to you 
reporting your withholding. 
 
VOLUNTEERING TO BE IN THE STUDY 
 
It is your choice if you want to be in the study.  No one can force you to be in the study.  You may not 
want to be in this study or you may leave the study at any time without penalty or loss of benefits to 
which you are otherwise entitled.   
 
The Investigator, the sponsor company, or IntegReview may take you out of the study without your 
permission, at any time, for the following reasons: 
 
 
• 
If you do not follow the Investigator’s instructions  
• 
If we find out you should not be in the study 
• 
If the study is stopped 
• 
If it becomes harmful to your health 
 
If you leave the study or if you are taken out of the study, you may be asked to return for a final visit to 
have some end of study evaluations or tests.  If information generated from this study is published or 
presented, your identity will not be revealed.  If you leave the study, no more information about you will 
be collected for this study.  However, all of the information you gave us before you left the study will still 
be used.  
 
NEW FINDINGS 
 
If there is new information or any significant new findings that could relate to your willingness to 
continue participation we will tell you.  You can then decide if you still want to be in the study.   
 
THE REASON FOR INSTITUTIONAL REVIEW BOARDS AND INFORMED CONSENT 
 
What is a consent form? 
The informed consent document contains information required by federal regulations.  The informed 
consent document must be approved by an Institutional Review Board (IRB). 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 10 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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What is an Institutional Review Board (IRB)? 
An Institutional Review Board (IRB) is a group of people that reviews research studies.  The main goal of 
this review is to protect the rights and well being of the human subjects participating in research studies. 
 
IntegReview, the IRB for this study 
IntegReview is an IRB whose board members provide IRB services across the United States, Canada, 
Japan and Latin America. 
 
To meet requirements of the law, the IntegReview Boards currently include:  
 
• 
Doctors  
• 
Pharmacists  
• 
Nurses  
• 
Toxicologists (people who study the harmful effects of chemicals)  
• 
Other specialists 
• 
Others who do not have a background in science/medicine 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 11 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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AGREEMENT TO BE IN THE STUDY 
 
This consent form contains important information to help you decide if you want to be in the study.  If 
you have any questions that are not answered in this consent form, ask one of the study staff.  
 
Please answer YES or NO to the following questions: 
 
A. 
Is this document in a language you understand?  
 
 
 
 
 
 
 
B. 
Do you understand the information in this consent form?  
 
 
 
 
 
 
C. 
Have you been given enough time to ask questions and talk about the study? 
 
 
 
 
D. 
Have all of your questions been answered to your satisfaction? 
 
 
 
 
 
 
E. 
Do you think you received enough information about the study?  
 
 
 
 
 
F. 
Do you volunteer to be in this study of your own free will and without being  
pressured by the Investigator or study staff? 
 
 
 
 
 
 
 
 
G. 
Do you know that you can leave the study at any time without giving 
a reason and without affecting your health care?  
 
 
 
 
 
 
 
H. 
Do you know that your health records from this study may be reviewed 
by the sponsor company and by government authorities?  
 
 
 
 
 
 
I. 
Do you know that you cannot be in another study while you are in this study? 
 
 
 
 
IF YOU ANSWERED “NO” TO ANY OF THE ABOVE QUESTIONS, 
OR YOU ARE UNABLE TO ANSWER ANY OF THE ABOVE QUESTIONS, 
YOU SHOULD NOT SIGN THIS CONSENT FORM. 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
  
 
 
 
 
 
 
 
 
 
 
Printed Name of Person Explaining Consent Form 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Person Explaining Consent Form 
 
 
 
 
 
Date 
 
 
 
You will be given a signed and dated copy of this consent form to keep. 
 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 12 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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Authorization and Release Form 
 
I hereby for good and valuable consideration grant to Thomas J. Stephens & Associates, the study 
sponsor and their respective affiliates, agencies, agents, employees, and assigns (collectively, “Authorized 
Entities”), the unrestricted, royalty free, irrevocable and perpetual right and permission to reproduce, 
distribute, broadcast and/or otherwise use for advertising and other commercial/noncommercial purposes:  
(i) my name, likeness, image, video, and any other biographical or personal information (“Personal 
Content”); and (ii) any statement or endorsement, or any portions thereof (“Testimonial(s)”), made by me 
relating to the study sponsor’s products (“Products”), in any and all media now known or later developed, 
worldwide in perpetuity, without further compensation or approval by me.     
 
I hereby assign to the Authorized Entities all of my world-wide right, title and interest, including my 
copyright interests and all renewals, reissues and extensions thereof, in and to the Personal Content and 
Testimonial(s), including without limitation, any photographic portraits, sound recordings and video 
performances of and/or by me in connection with the Personal Content and/or Testimonial(s).    
  
I am at least 21 years of age, and competent to contract in my own name.  I have read and understand this 
Authorization and Release. 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Person Explaining Release Form 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Person Explaining Release Form 
 
 
 
 
 
Date  
 
 
 
Copy of consent form given to subject on ______________ (date) by ______________ (initials) 
 
You will be given a signed and dated copy of this consent form to keep. 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 13 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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AUTHORIZATION TO USE AND DISCLOSE PERSONAL HEALTH INFORMATION FOR 
RESEARCH 
  
THIS SECTION DESCRIBES YOUR RIGHTS AND HOW PERSONAL HEALTH INFORMATION 
COLLECTED ABOUT YOU DURING THIS STUDY MAY BE USED AND DISCLOSED AND HOW 
YOU CAN GET ACCESS TO THIS INFORMATION.  PLEASE REVIEW IT CAREFULLY. 
  
The United States government has issued a privacy rule to protect the privacy rights of patients.  This rule 
was issued under a law called the Health Insurance Portability and Accountability Act of 1996 
(HIPAA).  The Privacy Rule is designed to protect the confidentiality of your personal health 
information.  The document you are reading, called an “Authorization,” describes your rights and 
explains how your health information will be used and disclosed (shared). 
  
Federal law requires hospitals, researchers and health care providers to protect the privacy of information 
that identifies you and relates to your past, present and future physical and mental health or conditions. 
  
All information collected during the study will be retained by the study doctor and the Study Sponsor, 
except as required by law.  Information from this study will be given to the sponsor.  “Sponsor” includes 
any persons or companies, which are contracted by the sponsor to have access to the research information 
during and after the study.  The information will also be given to the U.S. Food and Drug Administration 
(FDA).  Study records which identify you and the consent form signed by you will be inspected and/or 
copied for research or regulatory purposes by: 
  
• 
Sponsor  
• 
Agents for the sponsor 
• 
The US Food and Drug Administration (FDA) 
• 
Department of Health and Human Services (DHHS) agencies 
• 
IntegReview IRB  
  
Because of the need to release information to these parties, absolute confidentiality cannot be 
guaranteed.  The results of this research study may be presented at meetings or in publications; however, 
your identity will not be disclosed in those presentations. 
  
For purposes of study reporting, you will be identified by your initials and code numbers only.  However, 
your name, date of birth, address, and phone number will be kept on record by the study doctor in case 
you need to be contacted in the future about this study. 
  
After your personal health information is disclosed to the Study Sponsor, the results of the study may be 
reanalyzed at a later date and may be combined with the results of other studies.   The Study Sponsor and 
people who work with the Study Sponsor may use the results of this study for other research purposes, 
including:  
  
• 
Developing a better understanding of the disease; 
• 
Improving the design of future actual use trials 
  
After the study staff or the study doctor discloses your personal health information to others, it could be 
re-disclosed and no longer protected by federal privacy laws. 
  


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 14 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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This permission to share your personal health information for this study does not have an expiration 
date.  If you do not withdraw this Authorization in writing, it will remain in effect indefinitely. Your 
study doctor will keep this Authorization for at least 6 years.  If you no longer want to share your personal 
health information, you may cancel your permission at any time by writing to the study staff and/or the 
study doctor at the address below: 
 
Thomas J. Stephens & Associates, Inc. 
5050 Edison Ave., Suite 202 
Colorado Springs, CO  80915 
 
You have the right to see and get a copy of your records related to the study for as long as the study 
doctor has this information.  However, by signing this Authorization you agree that you might not be able 
to review or receive some of your records related to the study until after the study has been completed. 
  
If you cancel your permission after you have started in the study, the study staff and the study doctor will 
stop collecting your personal health information unless the information concerns an adverse event (a bad 
effect) related to the study.  If an adverse event occurs, your entire medical record may be reviewed.  All 
information that has already been collected for study purposes, and any new information about an adverse 
event related to the study, will be sent to the study sponsor.  Although they will stop collecting new 
information about you, they will need to use the information they have already collected to evaluate the 
study results.  If you start the study and then cancel your permission, you will not be able to continue to 
participate in the study.  This is because the study staff and/or the study doctor would not be able to 
collect the information needed to evaluate the study results. 
  
If you withdraw from the study but do not withdraw your Authorization, new personal health information 
may be collected until this study ends.  
  
You may decide not to give permission for the release of your personal health information for this 
study.  In that case, you will not be able to participate.  This is because the study staff and study doctor 
would not be able to collect the information needed to evaluate the study results. 
  
At the completion of the study, you have the right to access your protected health information that is 
created during this research study that relates to your treatment or to payment, provided such information 
is not exempted under certain laws and regulations.  To request this information, please contact the study 
doctor at the address listed above. 
  
Your Right to Access Health Information 
 
Subject to certain exceptions prescribed by law, you have a right to request access to the health 
information that we hold about you and to request changes if your health information is incorrect or 
incomplete. Any request for access or corrections should be made to the principal doctor conducting this 
study. 
 
Your records obtained while you are in this trial, as well as related health records, will remain strictly 
confidential at all times.  However, these will need to be made available to others working on the 
Sponsor’s behalf, the Independent Ethics Committee members and Medicines Regulatory Authorities. 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Kun Qian, M.D. 
Informed Consent 
 
Page 15 of 15 
APPROVED BY 
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SEPTEMBER 16, 2016 
 
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By signing the consent form you agree to this access for the current trial and any further research that may 
be done.  However, the Sponsor will take steps to protect your personal information and will not include 
your name on any sponsor forms, reports, publications, or in any future disclosures.  If you withdraw 
from the study, we will no longer collect your personal information, but we may need to continue to use 
information already collected. 
 
Personal data which may be sensitive (e.g., date of birth) will be collected and processed, but only for 
research purposes in connection with this trial. 
 
The trial data will be sent around the world, but you will not be referred to by name or identified in any 
report or publication nor could the data be traced back to you.  Your data may be transferred to a country 
that does not have the same level of personal data protection as within the United States.  However, 
The Sponsor maintains high standards of confidentiality and protection. 
 
The Sponsor (who will control the use of the data) will take steps to ensure your personal data is 
protected. 
 
By taking part in this trial you agree not to restrict the use of any data even if you withdraw from the trial 
and agree to the transfer of your personal data to other Sponsor companies and to Medicines Regulatory 
Authorities both within and outside of Europe. 
 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
 


APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
INFORMED CONSENT DOCUMENT 
AGREEMENT TO BE IN A RESEARCH STUDY 
 
NAME OF TESTING COMPANY: 
Thomas J. Stephens & Associates, Inc.  
 
NUMBER AND TITLE OF STUDY: 
C16-CD020 (GLI.04.SPR.US10354); “A Multi-
Center Clinical Trial to Evaluate the Efficacy of 
Two Acne Treatments” 
NAME OF PERSON IN CHARGE OF  
THE RESEARCH STUDY 
 (STUDY DOCTOR/INVESTIGATOR): 
Edward Lain, MD 
 
TELEPHONE NUMBER(S), DAYTIME: 
 
512-279-2545 
AFTER HOURS:   
 
 
 
 
512-844-4500 
 
 
INTRODUCTION 
 
You are being invited to volunteer for a clinical research study.  You must read and sign this form before 
you agree to take part in this study.  This form will give you more information about this study.  Please ask 
as many questions as you need to before you decide if you want to be in the study.  You should not sign this 
form if you have any questions that have not been answered. 
 
Thomas J. Stephens & Associates, Inc., a contract research organization, is being paid by the sponsor (the 
company paying for this study) to conduct this research study.   
 
You must be honest with the Investigator about your health history or it may not be safe for you to be in this 
study. 
 
PURPOSE OF THE STUDY 
 
The purpose of this study is to evaluate the efficiency of 2 acne treatments for 24 weeks of use in adult 
men and women with mild to moderate facial acne, at least 5 inflammatory lesions, and at least 10 – 100 
non-inflammatory lesions. 
 
HOW LONG THE STUDY WILL LAST AND HOW MANY PEOPLE WILL BE IN THE STUDY 
 
This study will last 24 weeks and have up to 8 visits. At least 100 subjects, men and women between the 
ages of 21-45, are expected to complete this study, with at least 50 subjects completed per cell. Each site 
is to enroll no more than 40 subjects, with at least 100 subjects expected to complete when combined. 
 
TO BE IN THIS STUDY 
 
You must: 
 
• 
Be a man or woman age 21 to 45 years at the time of enrollment. 
• 
Have mild to moderate acne on the face as determined by the Investigator or designee. 
• 
Have at least 5 inflammatory lesions as determined by the Investigator or designee. 
• 
Have 10 – 100 non-inflammatory lesions as determined by the Investigator or designee. 
• 
Be willing to use the test products as instructed for 24 weeks.  
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
Page 2 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
• 
Be willing and able to comply with all of the time commitments and procedural requirements of the 
clinical trial protocol. 
• 
Be willing to provide written informed consent including photo release, Health Insurance Portability 
and Accountability Act (HIPAA), and be able to read, speak, write, understand English and be willing 
to share personal information and data, as verified by signing a written authorization at the screening. 
• 
Be willing to withhold all facial treatments during the course of the study including botulinum toxin, 
injectable fillers, microdermabrasion, IPL, peels, facials, laser treatments and tightening treatments.  
Waxing and threading is allowed but not facial laser hair removal. 
• 
Males must be regular shavers and willing to shave on the day of the study visits (prior to clinic 
visits). 
• 
Women of child bearing potential must be willing to take a urine pregnancy test prior to study 
enrollment, at week 24, and when deemed appropriate by the Investigator and/or Sponsor. 
• 
Individuals of child bearing potential must use an acceptable method of contraception throughout the 
study.  Acceptable methods of birth control include: 
o Oral and other system contraceptives. Individuals must be on a stable use for 3 
months prior to study enrollment. Individuals on oral contraceptives must not alter 
their use, including dose or regimen for the duration of the study 
o Double barrier 
o Bilateral tubal ligation (tubes tied) 
o Partner vasectomy 
o Abstinence 
• 
Be willing to follow study requirements and report any changes in health status or medications, side 
effect symptoms, or reactions immediately. 
• 
Be stable on any medication you are taking for at least 30 days 
 
YOU CANNOT BE ON THE STUDY 
 
If you: 
 
• 
Have been diagnosed with allergies to topical acne products. 
• 
Have a condition and/or disease of the skin that the Investigator deems inappropriate for participation. 
• 
Are a woman who is breastfeeding, pregnant, or planning to become pregnant during the study. 
• 
Have pre-existing or dormant dermatologic conditions on the face (e.g., psoriasis, rosacea, eczema, 
seborrheic dermatitis, severe excoriations etc.) which in the opinion of the Investigator could interfere 
with the outcome of the study. 
• 
Have a history of immunosuppression/immune deficiency disorders (including HIV infection or 
AIDS) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, 
cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, 
Remicade, Stelara.).  
• 
Have an uncontrolled disease such as asthma, diabetes, hypertension, hyperthyroidism, or 
hypothyroidism. Individuals having multiple health conditions may be excluded from participation 
even if the conditions are controlled by diet, medication, etc. at the Investigator’s discretion. 
• 
Are currently participating in another facial usage study or have participated in a clinical trial within 4 
weeks prior to inclusion into the study. 
• 
Have a history of skin cancer on the face within the past 5 years. 
• 
Have any planned surgeries and/or invasive medical procedures during the course of the study. 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
Page 3 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
• 
Have started hormone replacement therapies (HRT) or hormones for birth control less than 3 months 
prior to study entry or plan on starting, stopping, or changing doses of HRT or hormones for birth 
control during the study. 
• 
Have facial sunburn or excessive tanned facial skin or are not willing to avoid daily sun exposure on 
the face and the use of tanning beds or sunless tanning products for the duration of the study. 
• 
Have severe acne, acne conglobata, multiple nodules or cysts (more than 2). 
• 
Are currently taking a natural or prescription testosterone blocker (e.g. saw palmetto, blask cohosh, 
chaste tree, chasteberry, spironolactone, drospirenone, progestins). 
• 
Are currently on a testosterone booster or prescription testosterone (e.g. DHEA, tribulus, testosterone 
cypionate, testosterone enanthate, Sustanon, testosterone propionate, testosterone phenylpropriate, 
Omnadren etc.). 
• 
Are currently taking or have taken within the last 30 days oral or topical prescription medications for 
acne such as Doxycycline, Minocycline, Clindamycin, Bactrim, Tetracycline, Erythromycin, 
Vibramycin and topical tretinoin (Retin A, Renova, Adapalene, Tazarotene), Azelaic acid, benzoyl 
peroxide, Dapsone, Sodium sulfacetamide, Differin, Epiduo. 
• 
Have used oral isotretinoin (Accutane) within the past 6-months. 
• 
Are routinely using (3x a week or more) topical over-the-counter (OTC) acne product (e.g. benzoyl 
peroxide, salicylic acid, alpha hydroxyl, beta hydroxyl and/or poly-hydroxy products or medicated 
cleansers, wipes, masks, scrubs, gels and creams) within 14 days of the study entry. 
• 
Are using or have used any systemic medication considered to affect the course of acne, specifically, 
but not exclusively antibiotics or steroids within the last 30 days prior to entry into the study. 
• 
Have excessive facial hair, including beard, mustache or goatee, or scars, which could interfere with 
evaluations as determined by the Investigator or designee. 
 
WHAT WILL HAPPEN DURING THE STUDY 
 
*Visit 1: Screening (* Visit 1 {Screening} AND Visit 2 {Baseline} may be combined into 1 Visit) 
 
You will: 
 
• 
Be given an IRB-approved Informed Consent Form (ICF), to read and sign. You will be given enough 
time to read the informed consent, and ask questions about the study, and sign 2 copies of this consent 
form. (1 for clinic records, 1 for your records) 
• 
Be given an eligibility and health questionnaire to complete, and assigned a screening number. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Will be screened by the Investigator or designee to see if you qualify for the study. 
• 
If you do qualify for the study, you will: 
o Take a urine pregnancy test (females of child-bearing potential) 
o Have a dermatologist confirm your eligibility 
o Schedule your next appointment. 
 
*Visit 2: Baseline 
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Be screened by the Investigator or designee to see if you still qualify for the study. 
• 
Have your health and eligibility re-reviewed. 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
Page 4 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
• 
If you still qualify for the study you will: 
o Be assigned a subject number 
o Have photos taken of your face 
o Be randomly assigned to receive one of the test products & supporting facial cleanser, 
moisturizer & facial SPF 30  
o Be provided verbal and written usage instructions, and a daily diary to record product use 
o Schedule your next appointment 
 
 
Visits 3, 4 (Week 1, Week 2)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and returned to you. At week 2, your diary 
will be retained by the testing facility and you will be given a new diary 
• 
Have your product collected, weighed, and returned to you 
• 
Schedule your next appointment 
 
Visits 5, 6 (Week 6, Week 12)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Have photos taken of your face 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility and you 
will be given a new diary. 
• 
Have your product collected, weighed, and retained. New products will be dispensed as necessary. 
• 
Schedule your next appointment 
 
Visit 7 (Week 18)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility and you 
will be given a new diary. 
• 
Have your product collected, weighed, and returned to you 
• 
Schedule your next appointment 
 
Visit 8 (Week 24)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Take a urine pregnancy test (females of child-bearing potential). 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Have photos taken of your face 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility. 
• 
Have your product collected, weighed, and retained by the testing facility. 
 
Do not give the study product to other people and keep it out of the reach of children. 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
Page 5 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
RISKS OR DISCOMFORTS 
 
If you do not understand what any of these side effects mean, please ask the investigator or study staff to 
explain these terms to you.  
 
Because the study products are investigational, all of their side effects may not be known.  There may be 
rare and unknown side effects. Some of these may be life threatening. 
 
Possible risks associated with the product are, as with any other cosmetic and OTC products, signs of 
irritation including:  
 
• 
Itching 
• 
Burning 
• 
Stinging 
• 
Rash or other allergic reaction 
• 
Tingling 
• 
Scaling/Dryness 
• 
Redness 
 
In some cases, it is possible for a subject to develop allergic reactions to the test material(s). This risk is 
increased for individuals with a history of allergies, and individuals with asthma and/or a history of hives 
may also be affected. Symptoms include rash, hives, and itching. 
 
You must tell the Investigator or study staff about all side effects that you have. If you are not honest 
about your side effects, it may not be safe for you to stay in the study. 
 
BIRTH CONTROL, DANGERS OF PREGNANCY AND BREASTFEEDING 
 
If you are a female, you must not get pregnant while in this study. The only certain way to not get 
pregnant is to not have sex.  If you are a female and choose to have sex, you must use a type of birth 
control.   
 
Even if you use birth control during the study, there is a chance you could become pregnant.  If you are 
pregnant or become pregnant during the study, test products or procedures may involve unforeseeable 
risks to the unborn baby. 
 
A pregnancy test can be wrong.  If you become pregnant during the study, stop using the test products and 
call/inform the Investigator at once. 
 
You cannot be in the study if you are breastfeeding.  It is not known whether the test products are safe for 
breast fed babies.  Therefore if you are breastfeeding a child then it may not be safe for you to participate 
in the study.   
 
POSSIBLE BENEFITS OF THE STUDY 
 
You will not get any medical benefit from being in this study, and there is no promise that your condition 
(acne) will get better.  It might stay the same or it might get worse.  Your participation will provide 
information that may help others. There may be other marketed products that claim to have similar 
benefits. 
 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
Page 6 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
OTHER OPTIONS TO PARTICIPATING IN THE STUDY   
 
Since this study is for research only, the only other choice would be not to be in the study. 
 
STUDY AND TEST PRODUCT CONFIDENTIALITY 
 
To participate in this study, you must agree to keep any information relating to the design, identity or use 
of these test product samples confidential.  
 
On rare occasions, the sponsor may allow the testing company to disclose to you the name of the test 
products if you are not given this information during the study. This information is typically not provided 
until the end of the study or after the test products have been released for sale to the public. The study 
doctor or study staff will notify you if the sponsor allows us to give you this information. 
 
DISCLOSURE AGREEMENT 
 
This section explains how personal health information collected about you for the study may be used.  
Your personal health information includes, but is not limited to, information that was collected for your 
entry into the study and information that is collected during the study.  The purpose of collecting this 
information is to allow the study staff and the Investigator to conduct the study, to evaluate the sponsor’s 
study products and to analyze the study results.   
 
You may decide not to give permission for the release of your personal health information for the study.  
In that case, you will not be able to participate in the study.   This is because the study staff and/or the 
Investigator would not be able to collect the information needed to evaluate the sponsor’s study products. 
 
People who may inspect your personal and health information includes the Investigator, the Institutional 
Review Board, IntegReview IRB, FDA and other regulatory authorities from the United States or other 
countries, the study sponsor and people that work with the sponsor which includes, monitoring 
committees, contract research organizations, and consultants who have contracts with the company to do 
the study and review the study results. These reviews are done to check on the quality of the study and 
also for other purposes allowed by law. 
 
The results of the study may be published in a medical book or journal, or presented at meetings for 
educational purposes.  Neither your name, nor any other personal health information that specifically 
identifies you, will be used in those materials or presentations.    
 
You may ask the Investigator to see and copy your personal health information related to the study.  You 
may also ask the Investigator to correct any study related information about you that is wrong.  You may 
have to wait until the end of the study to see your study records, so that the study can be organized 
properly.   
 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
Page 7 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
This permission to share your personal health information for this study does not have an expiration date.  
If you no longer want to share your personal health information, you may cancel your permission at any 
time by writing to the study staff and/or the Investigator at the address below: 
 
Austin Institute for Clinical Research, Inc. 
302 N. Heatherwilde Blvd., Suite 300 
Pflugerville, TX  78660 
 
If you cancel your permission after you have started in the study, the study staff and the Investigator will 
stop collecting your personal health information.  Although they will stop collecting new information 
about you, they will need to use the information they have already collected to evaluate the study results.  
If you start the study and then cancel your permission, you will not be able to continue to participate in 
the study.  This is because the study staff and/or the Investigator would not be able to collect the 
information needed to evaluate the study.  
 
Thomas J. Stephens & Associates and the sponsor will make every effort to keep your personal health 
information private.  But after the study staff or the Investigator share your personal health information 
from the study, federal privacy laws may not keep it private.  There might be laws in your state or other 
federal laws that would protect the privacy of this information. 
 
CONFIDENTIALITY  
 
Your records of being in this study will be kept private except when ordered by law.    The following 
people will have access to your study records: 
 
• 
The Investigator 
• 
Sponsor company or research institution [including monitor(s) and auditor(s)] 
• 
Other country, state or federal regulatory agencies 
• 
IntegReview IRB 
 
The Institutional Review Board (IRB), IntegReview, and accrediting agencies may inspect and copy your 
records, which may have your name on them.  Therefore, total confidentiality cannot be guaranteed.  If 
the study results are presented at meetings or printed in publications, your name will not be used. 
  
IN CASE OF STUDY RELATED INJURY 
 
Side effects or complications, both foreseeable and unforeseeable, are possible in any research study 
without any fault to you, the Investigator, the study site, or the study sponsor. If you get hurt or sick as a 
direct result of being in this study, the sponsor will pay the costs of reasonable medical treatment.  To ask 
questions about this, talk to the Investigator or study staff.   
 
The sponsor’s policy does not offer compensation for other expenses.  Be aware that your health care 
payer/insurer might not cover the costs of study-related injuries or illnesses. 
Unreimbursed medical expenses not covered by insurance or other third party coverage will be 
reimbursed by the sponsor for medical treatment for any injury that, in the opinion of the study doctor and 
the sponsor, is directly caused by the investigational product or by procedures required by the study 
protocol which would not have been performed as part of your regular medical care. 
 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
Page 8 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
LEGAL RIGHTS 
 
You will not lose any of your legal rights by signing this consent form. 
 
CONTACT INFORMATION 
 
If you have questions, concerns, or complaints about this study or to report a study related injury, contact: 
 
Edward Lain, MD 
512-279-2545 daytime telephone number  
512-844-4500 after hours number 
 
If you are unable to reach anyone at the number(s) listed above and you need medical attention, 
please go to the nearest emergency room. 
 
If you do not want to talk to the Investigator or study staff, if you have concerns or complaints about the 
research, or to ask questions about your rights as a study subject you may contact IntegReview.  
IntegReview’s policy indicates that all concerns/complaints are to be submitted in writing for review at a 
convened IRB meeting to: 
 
Mailing Address:            OR            Email Address: 
Chairperson 
IntegReview IRB 
3815 S. Capital of Texas Highway 
Suite 320 
Austin, TX  78704 
integreview@integreview.com 
 
If you are unable to provide your concerns/complaints in writing or if this is an emergency situation 
regarding subject safety, contact our office at: 
 
512-326-3001 or 
toll free at 1-877-562-1589 
between 8 a.m. and 5 p.m. Central Time 
 
IntegReview has approved the information in this consent form and has given approval for the 
Investigator to do the study. This does not mean IntegReview has approved your being in the study.  You 
must consider the information in this consent form for yourself and decide if you want to be in this study. 
 
PAYMENT FOR BEING IN THE STUDY 
 
You may receive up to $575.00 for being in the study. You will be paid per completed visit as follows: 
   
Visit 
Compensation (amount) 
Screening/Baseline (Visit 1, 2) 
$40.00 
Visit 3 
$60.00 
Visit 4 
$65.00 
Visit 5 
$75.00 
Visit 6 
$90.00 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
Page 9 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
Visit 7 
$95.00 
Visit 8 
$150.00 
 
If you choose to leave or are withdrawn from the study for any reason before finishing all visits you will 
be paid for each completed visit.  You will receive payment at the end of each study visit. 
 
If you do not qualify for any reason, you will be paid $20.00, which will be mailed to you within 2 weeks 
of the baseline study visit. 
 
If you are paid $600.00 or more by Thomas J. Stephens & Associates, Inc. in a calendar year, those 
payments will be reported to the Internal Revenue Service via form 1099-MISC. As required by tax laws, 
if you withhold your social security number, Thomas J. Stephens & Associates, Inc. is required to 
withhold 28% of your payment for tax purposes. In this case a form 1099-MISC will be sent to you 
reporting your withholding. 
 
VOLUNTEERING TO BE IN THE STUDY 
 
It is your choice if you want to be in the study.  No one can force you to be in the study.  You may not 
want to be in this study or you may leave the study at any time without penalty or loss of benefits to 
which you are otherwise entitled.   
 
The Investigator, the sponsor company, or IntegReview may take you out of the study without your 
permission, at any time, for the following reasons: 
 
 
• 
If you do not follow the Investigator’s instructions  
• 
If we find out you should not be in the study 
• 
If the study is stopped 
• 
If it becomes harmful to your health 
 
If you leave the study or if you are taken out of the study, you may be asked to return for a final visit to 
have some end of study evaluations or tests.  If information generated from this study is published or 
presented, your identity will not be revealed.  If you leave the study, no more information about you will 
be collected for this study.  However, all of the information you gave us before you left the study will still 
be used.  
 
NEW FINDINGS 
 
If there is new information or any significant new findings that could relate to your willingness to 
continue participation we will tell you.  You can then decide if you still want to be in the study.   
 
THE REASON FOR INSTITUTIONAL REVIEW BOARDS AND INFORMED CONSENT 
 
What is a consent form? 
The informed consent document contains information required by federal regulations.  The informed 
consent document must be approved by an Institutional Review Board (IRB). 
 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
Page 10 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
What is an Institutional Review Board (IRB)? 
An Institutional Review Board (IRB) is a group of people that reviews research studies.  The main goal of 
this review is to protect the rights and well being of the human subjects participating in research studies. 
 
IntegReview, the IRB for this study 
IntegReview is an IRB whose board members provide IRB services across the United States, Canada, 
Japan and Latin America. 
 
To meet requirements of the law, the IntegReview Boards currently include:  
 
• 
Doctors  
• 
Pharmacists  
• 
Nurses  
• 
Toxicologists (people who study the harmful effects of chemicals)  
• 
Other specialists 
• 
Others who do not have a background in science/medicine 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
Page 11 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
AGREEMENT TO BE IN THE STUDY 
 
This consent form contains important information to help you decide if you want to be in the study.  If 
you have any questions that are not answered in this consent form, ask one of the study staff.  
 
Please answer YES or NO to the following questions: 
 
A. 
Is this document in a language you understand?  
 
 
 
 
 
 
 
B. 
Do you understand the information in this consent form?  
 
 
 
 
 
 
C. 
Have you been given enough time to ask questions and talk about the study? 
 
 
 
 
D. 
Have all of your questions been answered to your satisfaction? 
 
 
 
 
 
 
E. 
Do you think you received enough information about the study?  
 
 
 
 
 
F. 
Do you volunteer to be in this study of your own free will and without being  
pressured by the Investigator or study staff? 
 
 
 
 
 
 
 
 
G. 
Do you know that you can leave the study at any time without giving 
a reason and without affecting your health care?  
 
 
 
 
 
 
 
H. 
Do you know that your health records from this study may be reviewed 
by the sponsor company and by government authorities?  
 
 
 
 
 
 
I. 
Do you know that you cannot be in another study while you are in this study? 
 
 
 
 
IF YOU ANSWERED “NO” TO ANY OF THE ABOVE QUESTIONS, 
OR YOU ARE UNABLE TO ANSWER ANY OF THE ABOVE QUESTIONS, 
YOU SHOULD NOT SIGN THIS CONSENT FORM. 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
  
 
 
 
 
 
 
 
 
 
 
Printed Name of Person Explaining Consent Form 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Person Explaining Consent Form 
 
 
 
 
 
Date 
 
 
 
You will be given a signed and dated copy of this consent form to keep. 
 
 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
Page 12 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
Authorization and Release Form 
 
I hereby for good and valuable consideration grant to Thomas J. Stephens & Associates, the study 
sponsor and their respective affiliates, agencies, agents, employees, and assigns (collectively, “Authorized 
Entities”), the unrestricted, royalty free, irrevocable and perpetual right and permission to reproduce, 
distribute, broadcast and/or otherwise use for advertising and other commercial/noncommercial purposes:  
(i) my name, likeness, image, video, and any other biographical or personal information (“Personal 
Content”); and (ii) any statement or endorsement, or any portions thereof (“Testimonial(s)”), made by me 
relating to the study sponsor’s products (“Products”), in any and all media now known or later developed, 
worldwide in perpetuity, without further compensation or approval by me.     
 
I hereby assign to the Authorized Entities all of my world-wide right, title and interest, including my 
copyright interests and all renewals, reissues and extensions thereof, in and to the Personal Content and 
Testimonial(s), including without limitation, any photographic portraits, sound recordings and video 
performances of and/or by me in connection with the Personal Content and/or Testimonial(s).    
  
I am at least 21 years of age, and competent to contract in my own name.  I have read and understand this 
Authorization and Release. 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Person Explaining Release Form 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Person Explaining Release Form 
 
 
 
 
 
Date  
 
 
 
Copy of consent form given to subject on ______________ (date) by ______________ (initials) 
 
You will be given a signed and dated copy of this consent form to keep. 
 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
Page 13 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
AUTHORIZATION TO USE AND DISCLOSE PERSONAL HEALTH INFORMATION FOR 
RESEARCH 
  
THIS SECTION DESCRIBES YOUR RIGHTS AND HOW PERSONAL HEALTH INFORMATION 
COLLECTED ABOUT YOU DURING THIS STUDY MAY BE USED AND DISCLOSED AND HOW 
YOU CAN GET ACCESS TO THIS INFORMATION.  PLEASE REVIEW IT CAREFULLY. 
  
The United States government has issued a privacy rule to protect the privacy rights of patients.  This rule 
was issued under a law called the Health Insurance Portability and Accountability Act of 1996 
(HIPAA).  The Privacy Rule is designed to protect the confidentiality of your personal health 
information.  The document you are reading, called an “Authorization,” describes your rights and 
explains how your health information will be used and disclosed (shared). 
  
Federal law requires hospitals, researchers and health care providers to protect the privacy of information 
that identifies you and relates to your past, present and future physical and mental health or conditions. 
  
All information collected during the study will be retained by the study doctor and the Study Sponsor, 
except as required by law.  Information from this study will be given to the sponsor.  “Sponsor” includes 
any persons or companies, which are contracted by the sponsor to have access to the research information 
during and after the study.  The information will also be given to the U.S. Food and Drug Administration 
(FDA).  Study records which identify you and the consent form signed by you will be inspected and/or 
copied for research or regulatory purposes by: 
  
• 
Sponsor  
• 
Agents for the sponsor 
• 
The US Food and Drug Administration (FDA) 
• 
Department of Health and Human Services (DHHS) agencies 
• 
IntegReview IRB  
  
Because of the need to release information to these parties, absolute confidentiality cannot be 
guaranteed.  The results of this research study may be presented at meetings or in publications; however, 
your identity will not be disclosed in those presentations. 
  
For purposes of study reporting, you will be identified by your initials and code numbers only.  However, 
your name, date of birth, address, and phone number will be kept on record by the study doctor in case 
you need to be contacted in the future about this study. 
  
After your personal health information is disclosed to the Study Sponsor, the results of the study may be 
reanalyzed at a later date and may be combined with the results of other studies.   The Study Sponsor and 
people who work with the Study Sponsor may use the results of this study for other research purposes, 
including:  
  
• 
Developing a better understanding of the disease; 
• 
Improving the design of future actual use trials 
  
After the study staff or the study doctor discloses your personal health information to others, it could be 
re-disclosed and no longer protected by federal privacy laws. 
  
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
Page 14 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
This permission to share your personal health information for this study does not have an expiration 
date.  If you do not withdraw this Authorization in writing, it will remain in effect indefinitely. Your 
study doctor will keep this Authorization for at least 6 years.  If you no longer want to share your personal 
health information, you may cancel your permission at any time by writing to the study staff and/or the 
study doctor at the address below: 
 
Austin Institute for Clinical Research, Inc. 
302 N. Heatherwilde Blvd., Suite 300 
Pflugerville, TX  78660 
 
You have the right to see and get a copy of your records related to the study for as long as the study 
doctor has this information.  However, by signing this Authorization you agree that you might not be able 
to review or receive some of your records related to the study until after the study has been completed. 
  
If you cancel your permission after you have started in the study, the study staff and the study doctor will 
stop collecting your personal health information unless the information concerns an adverse event (a bad 
effect) related to the study.  If an adverse event occurs, your entire medical record may be reviewed.  All 
information that has already been collected for study purposes, and any new information about an adverse 
event related to the study, will be sent to the study sponsor.  Although they will stop collecting new 
information about you, they will need to use the information they have already collected to evaluate the 
study results.  If you start the study and then cancel your permission, you will not be able to continue to 
participate in the study.  This is because the study staff and/or the study doctor would not be able to 
collect the information needed to evaluate the study results. 
  
If you withdraw from the study but do not withdraw your Authorization, new personal health information 
may be collected until this study ends.  
  
You may decide not to give permission for the release of your personal health information for this 
study.  In that case, you will not be able to participate.  This is because the study staff and study doctor 
would not be able to collect the information needed to evaluate the study results. 
  
At the completion of the study, you have the right to access your protected health information that is 
created during this research study that relates to your treatment or to payment, provided such information 
is not exempted under certain laws and regulations.  To request this information, please contact the study 
doctor at the address listed above. 
  
Your Right to Access Health Information 
 
Subject to certain exceptions prescribed by law, you have a right to request access to the health 
information that we hold about you and to request changes if your health information is incorrect or 
incomplete. Any request for access or corrections should be made to the principal doctor conducting this 
study. 
 
Your records obtained while you are in this trial, as well as related health records, will remain strictly 
confidential at all times.  However, these will need to be made available to others working on the 
Sponsor’s behalf, the Independent Ethics Committee members and Medicines Regulatory Authorities. 
 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
Page 15 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
By signing the consent form you agree to this access for the current trial and any further research that may 
be done.  However, the Sponsor will take steps to protect your personal information and will not include 
your name on any sponsor forms, reports, publications, or in any future disclosures.  If you withdraw 
from the study, we will no longer collect your personal information, but we may need to continue to use 
information already collected. 
 
Personal data which may be sensitive (e.g., date of birth) will be collected and processed, but only for 
research purposes in connection with this trial. 
 
The trial data will be sent around the world, but you will not be referred to by name or identified in any 
report or publication nor could the data be traced back to you.  Your data may be transferred to a country 
that does not have the same level of personal data protection as within the United States.  However, 
The Sponsor maintains high standards of confidentiality and protection. 
 
The Sponsor (who will control the use of the data) will take steps to ensure your personal data is 
protected. 
 
By taking part in this trial you agree not to restrict the use of any data even if you withdraw from the trial 
and agree to the transfer of your personal data to other Sponsor companies and to Medicines Regulatory 
Authorities both within and outside of Europe. 
 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
 
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APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 29, 2016 
 
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INFORMED CONSENT DOCUMENT 
AGREEMENT TO BE IN A RESEARCH STUDY 
 
NAME OF TESTING COMPANY: 
Austin Institute for Clinical Research, Inc. 
 
NUMBER AND TITLE OF STUDY: 
C16-CD020 (GLI.04.SPR.US10354); “A Multi-
Center Clinical Trial to Evaluate the Efficacy of 
Two Acne Treatments” 
NAME OF PERSON IN CHARGE OF  
THE RESEARCH STUDY 
 (STUDY DOCTOR/INVESTIGATOR): 
Edward Lain, MD 
 
TELEPHONE NUMBER(S), DAYTIME: 
 
512-279-2545 
AFTER HOURS:   
 
 
 
 
512-844-4500 
 
 
INTRODUCTION 
 
You are being invited to volunteer for a clinical research study.  You must read and sign this form before 
you agree to take part in this study.  This form will give you more information about this study.  Please ask 
as many questions as you need to before you decide if you want to be in the study.  You should not sign this 
form if you have any questions that have not been answered. 
 
Austin Institute for Clinical Research, Inc. is being paid by the sponsor (the company paying for this 
study) to conduct this research study.   
 
You must be honest with the Investigator about your health history or it may not be safe for you to be in this 
study. 
 
PURPOSE OF THE STUDY 
 
The purpose of this study is to evaluate the efficiency of 2 acne treatments for 24 weeks of use in adult 
men and women with mild to moderate facial acne, at least 5 inflammatory lesions, and at least 10 – 100 
non-inflammatory lesions. 
 
HOW LONG THE STUDY WILL LAST AND HOW MANY PEOPLE WILL BE IN THE STUDY 
 
This study will last 24 weeks and have up to 8 visits. At least 100 subjects, men and women between the 
ages of 21-45, are expected to complete this study, with at least 50 subjects completed per cell. Each site 
is to enroll no more than 40 subjects, with at least 100 subjects expected to complete when combined. 
 
TO BE IN THIS STUDY 
 
You must: 
 
• 
Be a man or woman age 21 to 45 years at the time of enrollment. 
• 
Have mild to moderate acne on the face as determined by the Investigator or designee. 
• 
Have at least 5 inflammatory lesions as determined by the Investigator or designee. 
• 
Have 10 – 100 non-inflammatory lesions as determined by the Investigator or designee. 
• 
Be willing to use the test products as instructed for 24 weeks.  


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
Page 2 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 29, 2016 
 
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• 
Be willing and able to comply with all of the time commitments and procedural requirements of the 
clinical trial protocol. 
• 
Be willing to provide written informed consent including photo release, Health Insurance Portability 
and Accountability Act (HIPAA), and be able to read, speak, write, understand English and be willing 
to share personal information and data, as verified by signing a written authorization at the screening. 
• 
Be willing to withhold all facial treatments during the course of the study including botulinum toxin, 
injectable fillers, microdermabrasion, IPL, peels, facials, laser treatments and tightening treatments.  
Waxing and threading is allowed but not facial laser hair removal. 
• 
Males must be regular shavers and willing to shave on the day of the study visits (prior to clinic 
visits). 
• 
Women of child bearing potential must be willing to take a urine pregnancy test prior to study 
enrollment, at week 24, and when deemed appropriate by the Investigator and/or Sponsor. 
• 
Individuals of child bearing potential must use an acceptable method of contraception throughout the 
study.  Acceptable methods of birth control include: 
o Oral and other system contraceptives. Individuals must be on a stable use for 3 
months prior to study enrollment. Individuals on oral contraceptives must not alter 
their use, including dose or regimen for the duration of the study 
o Double barrier 
o Bilateral tubal ligation (tubes tied) 
o Partner vasectomy 
o Abstinence 
• 
Be willing to follow study requirements and report any changes in health status or medications, side 
effect symptoms, or reactions immediately. 
• 
Be stable on any medication you are taking for at least 30 days 
 
YOU CANNOT BE ON THE STUDY 
 
If you: 
 
• 
Have been diagnosed with allergies to topical acne products. 
• 
Have a condition and/or disease of the skin that the Investigator deems inappropriate for participation. 
• 
Are a woman who is breastfeeding, pregnant, or planning to become pregnant during the study. 
• 
Have pre-existing or dormant dermatologic conditions on the face (e.g., psoriasis, rosacea, eczema, 
seborrheic dermatitis, severe excoriations etc.) which in the opinion of the Investigator could interfere 
with the outcome of the study. 
• 
Have a history of immunosuppression/immune deficiency disorders (including HIV infection or 
AIDS) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, 
cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, 
Remicade, Stelara.).  
• 
Have an uncontrolled disease such as asthma, diabetes, hypertension, hyperthyroidism, or 
hypothyroidism. Individuals having multiple health conditions may be excluded from participation 
even if the conditions are controlled by diet, medication, etc. at the Investigator’s discretion. 
• 
Are currently participating in another facial usage study or have participated in a clinical trial within 4 
weeks prior to inclusion into the study. 
• 
Have a history of skin cancer on the face within the past 5 years. 
• 
Have any planned surgeries and/or invasive medical procedures during the course of the study. 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
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FEBRUARY 29, 2016 
 
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• 
Have started hormone replacement therapies (HRT) or hormones for birth control less than 3 months 
prior to study entry or plan on starting, stopping, or changing doses of HRT or hormones for birth 
control during the study. 
• 
Have facial sunburn or excessive tanned facial skin or are not willing to avoid daily sun exposure on 
the face and the use of tanning beds or sunless tanning products for the duration of the study. 
• 
Have severe acne, acne conglobata, multiple nodules or cysts (more than 2). 
• 
Are currently taking a natural or prescription testosterone blocker (e.g. saw palmetto, blask cohosh, 
chaste tree, chasteberry, spironolactone, drospirenone, progestins). 
• 
Are currently on a testosterone booster or prescription testosterone (e.g. DHEA, tribulus, testosterone 
cypionate, testosterone enanthate, Sustanon, testosterone propionate, testosterone phenylpropriate, 
Omnadren etc.). 
• 
Are currently taking or have taken within the last 30 days oral or topical prescription medications for 
acne such as Doxycycline, Minocycline, Clindamycin, Bactrim, Tetracycline, Erythromycin, 
Vibramycin and topical tretinoin (Retin A, Renova, Adapalene, Tazarotene), Azelaic acid, benzoyl 
peroxide, Dapsone, Sodium sulfacetamide, Differin, Epiduo. 
• 
Have used oral isotretinoin (Accutane) within the past 6-months. 
• 
Are routinely using (3x a week or more) topical over-the-counter (OTC) acne product (e.g. benzoyl 
peroxide, salicylic acid, alpha hydroxyl, beta hydroxyl and/or poly-hydroxy products or medicated 
cleansers, wipes, masks, scrubs, gels and creams) within 14 days of the study entry. 
• 
Are using or have used any systemic medication considered to affect the course of acne, specifically, 
but not exclusively antibiotics or steroids within the last 30 days prior to entry into the study. 
• 
Have excessive facial hair, including beard, mustache or goatee, or scars, which could interfere with 
evaluations as determined by the Investigator or designee. 
 
WHAT WILL HAPPEN DURING THE STUDY 
 
*Visit 1: Screening (* Visit 1 {Screening} AND Visit 2 {Baseline} may be combined into 1 Visit) 
 
You will: 
 
• 
Be given an IRB-approved Informed Consent Form (ICF), to read and sign. You will be given enough 
time to read the informed consent, and ask questions about the study, and sign 2 copies of this consent 
form. (1 for clinic records, 1 for your records) 
• 
Be given an eligibility and health questionnaire to complete, and assigned a screening number. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Will be screened by the Investigator or designee to see if you qualify for the study. 
• 
If you do qualify for the study, you will: 
o Take a urine pregnancy test (females of child-bearing potential) 
o Have a dermatologist confirm your eligibility 
o Schedule your next appointment. 
 
*Visit 2: Baseline 
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Be screened by the Investigator or designee to see if you still qualify for the study. 
• 
Have your health and eligibility re-reviewed. 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
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APPROVED BY 
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FEBRUARY 29, 2016 
 
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• 
If you still qualify for the study you will: 
o Be assigned a subject number 
o Have photos taken of your face 
o Be randomly assigned to receive one of the test products & supporting facial cleanser, 
moisturizer & facial SPF 30  
o Be provided verbal and written usage instructions, and a daily diary to record product use 
o Schedule your next appointment 
 
 
Visits 3, 4 (Week 1, Week 2)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and returned to you. At week 2, your diary 
will be retained by the testing facility and you will be given a new diary 
• 
Have your product collected, weighed, and returned to you 
• 
Schedule your next appointment 
 
Visits 5, 6 (Week 6, Week 12)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Have photos taken of your face 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility and you 
will be given a new diary. 
• 
Have your product collected, weighed, and retained. New products will be dispensed as necessary. 
• 
Schedule your next appointment 
 
Visit 7 (Week 18)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility and you 
will be given a new diary. 
• 
Have your product collected, weighed, and returned to you 
• 
Schedule your next appointment 
 
Visit 8 (Week 24)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Take a urine pregnancy test (females of child-bearing potential). 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Have photos taken of your face 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility. 
• 
Have your product collected, weighed, and retained by the testing facility. 
 
Do not give the study product to other people and keep it out of the reach of children. 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
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APPROVED BY 
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FEBRUARY 29, 2016 
 
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RISKS OR DISCOMFORTS 
 
If you do not understand what any of these side effects mean, please ask the investigator or study staff to 
explain these terms to you.  
 
Because the study products are investigational, all of their side effects may not be known.  There may be 
rare and unknown side effects. Some of these may be life threatening. 
 
Possible risks associated with the product are, as with any other cosmetic and OTC products, signs of 
irritation including:  
 
• 
Itching 
• 
Burning 
• 
Stinging 
• 
Rash or other allergic reaction 
• 
Tingling 
• 
Scaling/Dryness 
• 
Redness 
 
In some cases, it is possible for a subject to develop allergic reactions to the test material(s). This risk is 
increased for individuals with a history of allergies, and individuals with asthma and/or a history of hives 
may also be affected. Symptoms include rash, hives, and itching. 
 
You must tell the Investigator or study staff about all side effects that you have. If you are not honest 
about your side effects, it may not be safe for you to stay in the study. 
 
BIRTH CONTROL, DANGERS OF PREGNANCY AND BREASTFEEDING 
 
If you are a female, you must not get pregnant while in this study. The only certain way to not get 
pregnant is to not have sex.  If you are a female and choose to have sex, you must use a type of birth 
control.   
 
Even if you use birth control during the study, there is a chance you could become pregnant.  If you are 
pregnant or become pregnant during the study, test products or procedures may involve unforeseeable 
risks to the unborn baby. 
 
A pregnancy test can be wrong.  If you become pregnant during the study, stop using the test products and 
call/inform the Investigator at once. 
 
You cannot be in the study if you are breastfeeding.  It is not known whether the test products are safe for 
breast fed babies.  Therefore if you are breastfeeding a child then it may not be safe for you to participate 
in the study.   
 
POSSIBLE BENEFITS OF THE STUDY 
 
You will not get any medical benefit from being in this study, and there is no promise that your condition 
(acne) will get better.  It might stay the same or it might get worse.  Your participation will provide 
information that may help others. There may be other marketed products that claim to have similar 
benefits. 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
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FEBRUARY 29, 2016 
 
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OTHER OPTIONS TO PARTICIPATING IN THE STUDY   
 
Since this study is for research only, the only other choice would be not to be in the study. 
 
STUDY AND TEST PRODUCT CONFIDENTIALITY 
 
To participate in this study, you must agree to keep any information relating to the design, identity or use 
of these test product samples confidential.  
 
On rare occasions, the sponsor may allow the testing company to disclose to you the name of the test 
products if you are not given this information during the study. This information is typically not provided 
until the end of the study or after the test products have been released for sale to the public. The study 
doctor or study staff will notify you if the sponsor allows us to give you this information. 
 
DISCLOSURE AGREEMENT 
 
This section explains how personal health information collected about you for the study may be used.  
Your personal health information includes, but is not limited to, information that was collected for your 
entry into the study and information that is collected during the study.  The purpose of collecting this 
information is to allow the study staff and the Investigator to conduct the study, to evaluate the sponsor’s 
study products and to analyze the study results.   
 
You may decide not to give permission for the release of your personal health information for the study.  
In that case, you will not be able to participate in the study.   This is because the study staff and/or the 
Investigator would not be able to collect the information needed to evaluate the sponsor’s study products. 
 
People who may inspect your personal and health information includes the Investigator, the Institutional 
Review Board, IntegReview IRB, FDA and other regulatory authorities from the United States or other 
countries, the study sponsor and people that work with the sponsor which includes, monitoring 
committees, contract research organizations, and consultants who have contracts with the company to do 
the study and review the study results. These reviews are done to check on the quality of the study and 
also for other purposes allowed by law. 
 
The results of the study may be published in a medical book or journal, or presented at meetings for 
educational purposes.  Neither your name, nor any other personal health information that specifically 
identifies you, will be used in those materials or presentations.    
 
You may ask the Investigator to see and copy your personal health information related to the study.  You 
may also ask the Investigator to correct any study related information about you that is wrong.  You may 
have to wait until the end of the study to see your study records, so that the study can be organized 
properly.   
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
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FEBRUARY 29, 2016 
 
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This permission to share your personal health information for this study does not have an expiration date.  
If you no longer want to share your personal health information, you may cancel your permission at any 
time by writing to the study staff and/or the Investigator at the address below: 
 
Austin Institute for Clinical Research, Inc. 
302 N. Heatherwilde Blvd., Suite 300 
Pflugerville, TX  78660 
 
If you cancel your permission after you have started in the study, the study staff and the Investigator will 
stop collecting your personal health information.  Although they will stop collecting new information 
about you, they will need to use the information they have already collected to evaluate the study results.  
If you start the study and then cancel your permission, you will not be able to continue to participate in 
the study.  This is because the study staff and/or the Investigator would not be able to collect the 
information needed to evaluate the study.  
 
Austin Institute for Clinical Research, Inc. and the sponsor will make every effort to keep your personal 
health information private.  But after the study staff or the Investigator share your personal health 
information from the study, federal privacy laws may not keep it private.  There might be laws in your 
state or other federal laws that would protect the privacy of this information. 
 
CONFIDENTIALITY  
 
Your records of being in this study will be kept private except when ordered by law.    The following 
people will have access to your study records: 
 
• 
The Investigator 
• 
Sponsor company or research institution [including monitor(s) and auditor(s)] 
• 
Other country, state or federal regulatory agencies 
• 
IntegReview IRB 
 
The Institutional Review Board (IRB), IntegReview, and accrediting agencies may inspect and copy your 
records, which may have your name on them.  Therefore, total confidentiality cannot be guaranteed.  If 
the study results are presented at meetings or printed in publications, your name will not be used. 
  
IN CASE OF STUDY RELATED INJURY 
 
Side effects or complications, both foreseeable and unforeseeable, are possible in any research study 
without any fault to you, the Investigator, the study site, or the study sponsor. If you get hurt or sick as a 
direct result of being in this study, the sponsor will pay the costs of reasonable medical treatment.  To ask 
questions about this, talk to the Investigator or study staff.   
 
The sponsor’s policy does not offer compensation for other expenses.  Be aware that your health care 
payer/insurer might not cover the costs of study-related injuries or illnesses. 
 
Unreimbursed medical expenses not covered by insurance or other third party coverage will be 
reimbursed by the sponsor for medical treatment for any injury that, in the opinion of the study doctor and 
the sponsor, is directly caused by the investigational product or by procedures required by the study 
protocol which would not have been performed as part of your regular medical care. 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
Page 8 of 15 
APPROVED BY 
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FEBRUARY 29, 2016 
 
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LEGAL RIGHTS 
 
You will not lose any of your legal rights by signing this consent form. 
 
CONTACT INFORMATION 
 
If you have questions, concerns, or complaints about this study or to report a study related injury, contact: 
 
Edward Lain, MD 
512-279-2545 daytime telephone number  
512-844-4500 after hours number 
 
If you are unable to reach anyone at the number(s) listed above and you need medical attention, 
please go to the nearest emergency room. 
 
If you do not want to talk to the Investigator or study staff, if you have concerns or complaints about the 
research, or to ask questions about your rights as a study subject you may contact IntegReview.  
IntegReview’s policy indicates that all concerns/complaints are to be submitted in writing for review at a 
convened IRB meeting to: 
 
Mailing Address:            OR            Email Address: 
Chairperson 
IntegReview IRB 
3815 S. Capital of Texas Highway 
Suite 320 
Austin, TX  78704 
integreview@integreview.com 
 
If you are unable to provide your concerns/complaints in writing or if this is an emergency situation 
regarding subject safety, contact our office at: 
 
512-326-3001 or 
toll free at 1-877-562-1589 
between 8 a.m. and 5 p.m. Central Time 
 
IntegReview has approved the information in this consent form and has given approval for the 
Investigator to do the study. This does not mean IntegReview has approved your being in the study.  You 
must consider the information in this consent form for yourself and decide if you want to be in this study. 
 
PAYMENT FOR BEING IN THE STUDY 
 
You may receive up to $575.00 for being in the study. You will be paid per completed visit as follows: 
   
Visit 
Compensation (amount) 
Screening/Baseline (Visit 1, 2) 
$40.00 
Visit 3 
$60.00 
Visit 4 
$65.00 
Visit 5 
$75.00 
Visit 6 
$90.00 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
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APPROVED BY 
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FEBRUARY 29, 2016 
 
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Visit 7 
$95.00 
Visit 8 
$150.00 
 
If you choose to leave or are withdrawn from the study for any reason before finishing all visits you will 
be paid for each completed visit.  You will receive payment at the end of each study visit. 
 
If you do not qualify for any reason, you will be paid $20.00, which will be mailed to you within 2 weeks 
of the baseline study visit. 
 
If you are paid $600.00 or more by Austin Institute for Clinical Research, Inc. in a calendar year, those 
payments will be reported to the Internal Revenue Service via form 1099-MISC. As required by tax laws, 
if you withhold your social security number, Austin Institute for Clinical Research, Inc. is required to 
withhold 28% of your payment for tax purposes. In this case a form 1099-MISC will be sent to you 
reporting your withholding. 
 
VOLUNTEERING TO BE IN THE STUDY 
 
It is your choice if you want to be in the study.  No one can force you to be in the study.  You may not 
want to be in this study or you may leave the study at any time without penalty or loss of benefits to 
which you are otherwise entitled.   
 
The Investigator, the sponsor company, or IntegReview may take you out of the study without your 
permission, at any time, for the following reasons: 
 
 
• 
If you do not follow the Investigator’s instructions  
• 
If we find out you should not be in the study 
• 
If the study is stopped 
• 
If it becomes harmful to your health 
 
If you leave the study or if you are taken out of the study, you may be asked to return for a final visit to 
have some end of study evaluations or tests.  If information generated from this study is published or 
presented, your identity will not be revealed.  If you leave the study, no more information about you will 
be collected for this study.  However, all of the information you gave us before you left the study will still 
be used.  
 
NEW FINDINGS 
 
If there is new information or any significant new findings that could relate to your willingness to 
continue participation we will tell you.  You can then decide if you still want to be in the study.   
 
THE REASON FOR INSTITUTIONAL REVIEW BOARDS AND INFORMED CONSENT 
 
What is a consent form? 
The informed consent document contains information required by federal regulations.  The informed 
consent document must be approved by an Institutional Review Board (IRB). 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
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FEBRUARY 29, 2016 
 
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What is an Institutional Review Board (IRB)? 
An Institutional Review Board (IRB) is a group of people that reviews research studies.  The main goal of 
this review is to protect the rights and well being of the human subjects participating in research studies. 
 
IntegReview, the IRB for this study 
IntegReview is an IRB whose board members provide IRB services across the United States, Canada, 
Japan and Latin America. 
 
To meet requirements of the law, the IntegReview Boards currently include:  
 
• 
Doctors  
• 
Pharmacists  
• 
Nurses  
• 
Toxicologists (people who study the harmful effects of chemicals)  
• 
Other specialists 
• 
Others who do not have a background in science/medicine 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
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FEBRUARY 29, 2016 
 
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AGREEMENT TO BE IN THE STUDY 
 
This consent form contains important information to help you decide if you want to be in the study.  If 
you have any questions that are not answered in this consent form, ask one of the study staff.  
 
Please answer YES or NO to the following questions: 
 
A. 
Is this document in a language you understand?  
 
 
 
 
 
 
 
B. 
Do you understand the information in this consent form?  
 
 
 
 
 
 
C. 
Have you been given enough time to ask questions and talk about the study? 
 
 
 
 
D. 
Have all of your questions been answered to your satisfaction? 
 
 
 
 
 
 
E. 
Do you think you received enough information about the study?  
 
 
 
 
 
F. 
Do you volunteer to be in this study of your own free will and without being  
pressured by the Investigator or study staff? 
 
 
 
 
 
 
 
 
G. 
Do you know that you can leave the study at any time without giving 
a reason and without affecting your health care?  
 
 
 
 
 
 
 
H. 
Do you know that your health records from this study may be reviewed 
by the sponsor company and by government authorities?  
 
 
 
 
 
 
I. 
Do you know that you cannot be in another study while you are in this study? 
 
 
 
 
IF YOU ANSWERED “NO” TO ANY OF THE ABOVE QUESTIONS, 
OR YOU ARE UNABLE TO ANSWER ANY OF THE ABOVE QUESTIONS, 
YOU SHOULD NOT SIGN THIS CONSENT FORM. 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
  
 
 
 
 
 
 
 
 
 
 
Printed Name of Person Explaining Consent Form 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Person Explaining Consent Form 
 
 
 
 
 
Date 
 
 
 
You will be given a signed and dated copy of this consent form to keep. 
 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
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FEBRUARY 29, 2016 
 
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Authorization and Release Form 
 
I hereby for good and valuable consideration grant to Austin Institute for Clinical Research, Inc., the 
study sponsor and their respective affiliates, agencies, agents, employees, and assigns (collectively, 
“Authorized Entities”), the unrestricted, royalty free, irrevocable and perpetual right and permission to 
reproduce, 
distribute, 
broadcast 
and/or 
otherwise 
use 
for 
advertising 
and 
other 
commercial/noncommercial purposes:  (i) my name, likeness, image, video, and any other biographical or 
personal information (“Personal Content”); and (ii) any statement or endorsement, or any portions thereof 
(“Testimonial(s)”), made by me relating to the study sponsor’s products (“Products”), in any and all 
media now known or later developed, worldwide in perpetuity, without further compensation or approval 
by me.     
 
I hereby assign to the Authorized Entities all of my world-wide right, title and interest, including my 
copyright interests and all renewals, reissues and extensions thereof, in and to the Personal Content and 
Testimonial(s), including without limitation, any photographic portraits, sound recordings and video 
performances of and/or by me in connection with the Personal Content and/or Testimonial(s).    
  
I am at least 21 years of age, and competent to contract in my own name.  I have read and understand this 
Authorization and Release. 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Person Explaining Release Form 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Person Explaining Release Form 
 
 
 
 
 
Date  
 
 
 
Copy of consent form given to subject on ______________ (date) by ______________ (initials) 
 
You will be given a signed and dated copy of this consent form to keep. 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
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AUTHORIZATION TO USE AND DISCLOSE PERSONAL HEALTH INFORMATION FOR 
RESEARCH 
  
THIS SECTION DESCRIBES YOUR RIGHTS AND HOW PERSONAL HEALTH INFORMATION 
COLLECTED ABOUT YOU DURING THIS STUDY MAY BE USED AND DISCLOSED AND HOW 
YOU CAN GET ACCESS TO THIS INFORMATION.  PLEASE REVIEW IT CAREFULLY. 
  
The United States government has issued a privacy rule to protect the privacy rights of patients.  This rule 
was issued under a law called the Health Insurance Portability and Accountability Act of 1996 
(HIPAA).  The Privacy Rule is designed to protect the confidentiality of your personal health 
information.  The document you are reading, called an “Authorization,” describes your rights and 
explains how your health information will be used and disclosed (shared). 
  
Federal law requires hospitals, researchers and health care providers to protect the privacy of information 
that identifies you and relates to your past, present and future physical and mental health or conditions. 
  
All information collected during the study will be retained by the study doctor and the Study Sponsor, 
except as required by law.  Information from this study will be given to the sponsor.  “Sponsor” includes 
any persons or companies, which are contracted by the sponsor to have access to the research information 
during and after the study.  The information will also be given to the U.S. Food and Drug Administration 
(FDA).  Study records which identify you and the consent form signed by you will be inspected and/or 
copied for research or regulatory purposes by: 
  
• 
Sponsor  
• 
Agents for the sponsor 
• 
The US Food and Drug Administration (FDA) 
• 
Department of Health and Human Services (DHHS) agencies 
• 
IntegReview IRB  
  
Because of the need to release information to these parties, absolute confidentiality cannot be 
guaranteed.  The results of this research study may be presented at meetings or in publications; however, 
your identity will not be disclosed in those presentations. 
  
For purposes of study reporting, you will be identified by your initials and code numbers only.  However, 
your name, date of birth, address, and phone number will be kept on record by the study doctor in case 
you need to be contacted in the future about this study. 
  
After your personal health information is disclosed to the Study Sponsor, the results of the study may be 
reanalyzed at a later date and may be combined with the results of other studies.   The Study Sponsor and 
people who work with the Study Sponsor may use the results of this study for other research purposes, 
including:  
  
• 
Developing a better understanding of the disease; 
• 
Improving the design of future actual use trials 
  
After the study staff or the study doctor discloses your personal health information to others, it could be 
re-disclosed and no longer protected by federal privacy laws. 
  


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This permission to share your personal health information for this study does not have an expiration 
date.  If you do not withdraw this Authorization in writing, it will remain in effect indefinitely. Your 
study doctor will keep this Authorization for at least 6 years.  If you no longer want to share your personal 
health information, you may cancel your permission at any time by writing to the study staff and/or the 
study doctor at the address below: 
 
Austin Institute for Clinical Research, Inc. 
302 N. Heatherwilde Blvd., Suite 300 
Pflugerville, TX  78660 
 
You have the right to see and get a copy of your records related to the study for as long as the study 
doctor has this information.  However, by signing this Authorization you agree that you might not be able 
to review or receive some of your records related to the study until after the study has been completed. 
  
If you cancel your permission after you have started in the study, the study staff and the study doctor will 
stop collecting your personal health information unless the information concerns an adverse event (a bad 
effect) related to the study.  If an adverse event occurs, your entire medical record may be reviewed.  All 
information that has already been collected for study purposes, and any new information about an adverse 
event related to the study, will be sent to the study sponsor.  Although they will stop collecting new 
information about you, they will need to use the information they have already collected to evaluate the 
study results.  If you start the study and then cancel your permission, you will not be able to continue to 
participate in the study.  This is because the study staff and/or the study doctor would not be able to 
collect the information needed to evaluate the study results. 
  
If you withdraw from the study but do not withdraw your Authorization, new personal health information 
may be collected until this study ends.  
  
You may decide not to give permission for the release of your personal health information for this 
study.  In that case, you will not be able to participate.  This is because the study staff and study doctor 
would not be able to collect the information needed to evaluate the study results. 
  
At the completion of the study, you have the right to access your protected health information that is 
created during this research study that relates to your treatment or to payment, provided such information 
is not exempted under certain laws and regulations.  To request this information, please contact the study 
doctor at the address listed above. 
  
Your Right to Access Health Information 
 
Subject to certain exceptions prescribed by law, you have a right to request access to the health 
information that we hold about you and to request changes if your health information is incorrect or 
incomplete. Any request for access or corrections should be made to the principal doctor conducting this 
study. 
 
Your records obtained while you are in this trial, as well as related health records, will remain strictly 
confidential at all times.  However, these will need to be made available to others working on the 
Sponsor’s behalf, the Independent Ethics Committee members and Medicines Regulatory Authorities. 
 


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Edward Lain, MD 
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By signing the consent form you agree to this access for the current trial and any further research that may 
be done.  However, the Sponsor will take steps to protect your personal information and will not include 
your name on any sponsor forms, reports, publications, or in any future disclosures.  If you withdraw 
from the study, we will no longer collect your personal information, but we may need to continue to use 
information already collected. 
 
Personal data which may be sensitive (e.g., date of birth) will be collected and processed, but only for 
research purposes in connection with this trial. 
 
The trial data will be sent around the world, but you will not be referred to by name or identified in any 
report or publication nor could the data be traced back to you.  Your data may be transferred to a country 
that does not have the same level of personal data protection as within the United States.  However, 
The Sponsor maintains high standards of confidentiality and protection. 
 
The Sponsor (who will control the use of the data) will take steps to ensure your personal data is 
protected. 
 
By taking part in this trial you agree not to restrict the use of any data even if you withdraw from the trial 
and agree to the transfer of your personal data to other Sponsor companies and to Medicines Regulatory 
Authorities both within and outside of Europe. 
 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
 


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INFORMED CONSENT DOCUMENT 
AGREEMENT TO BE IN A RESEARCH STUDY 
 
NAME OF TESTING COMPANY: 
Austin Institute for Clinical Research, Inc. 
 
NUMBER AND TITLE OF STUDY: 
C16-CD020 (GLI.04.SPR.US10354); “A Multi-
Center Clinical Trial to Evaluate the Efficacy of 
Two Acne Treatments” 
NAME OF PERSON IN CHARGE OF  
THE RESEARCH STUDY 
 (STUDY DOCTOR/INVESTIGATOR): 
Edward Lain, MD 
 
TELEPHONE NUMBER(S), DAYTIME: 
 
512-279-2545 
AFTER HOURS:   
 
 
 
 
512-844-4500 
 
 
INTRODUCTION 
 
You are being invited to volunteer for a clinical research study.  You must read and sign this form before 
you agree to take part in this study.  This form will give you more information about this study.  Please ask 
as many questions as you need to before you decide if you want to be in the study.  You should not sign this 
form if you have any questions that have not been answered. 
 
Austin Institute for Clinical Research, Inc. is being paid by the sponsor (the company paying for this 
study) to conduct this research study.   
 
You must be honest with the Investigator about your health history or it may not be safe for you to be in this 
study. 
 
PURPOSE OF THE STUDY 
 
The purpose of this study is to evaluate the efficiency of 2 acne treatments for 24 weeks of use in adult 
men and women with mild to moderate facial acne, at least 5 inflammatory lesions, and at least 10 – 100 
non-inflammatory lesions. 
 
HOW LONG THE STUDY WILL LAST AND HOW MANY PEOPLE WILL BE IN THE STUDY 
 
This study will last 24 weeks and have up to 8 visits. At least 100 subjects, men and women between the 
ages of 21-45, are expected to complete this study, with at least 50 subjects completed per cell.  
 
TO BE IN THIS STUDY 
 
You must: 
 
• 
Be a man or woman age 21 to 45 years at the time of enrollment. 
• 
Have mild to moderate acne on the face as determined by the Investigator or designee. 
• 
Have at least 5 inflammatory lesions as determined by the Investigator or designee. 
• 
Have 10 – 100 non-inflammatory lesions as determined by the Investigator or designee. 
• 
Be willing to use the test products as instructed for 24 weeks.  
• 
Be willing and able to comply with all of the time commitments and procedural requirements of the 
clinical trial protocol. 


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• 
Be willing to provide written informed consent including photo release, Health Insurance Portability 
and Accountability Act (HIPAA), and be able to read, speak, write, understand English and be willing 
to share personal information and data, as verified by signing a written authorization at the screening. 
• 
Be willing to withhold all facial treatments during the course of the study including botulinum toxin, 
injectable fillers, microdermabrasion, IPL, peels, facials, laser treatments and tightening treatments.  
Waxing and threading is allowed but not facial laser hair removal. 
• 
Males must be regular shavers and willing to shave on the day of the study visits (prior to clinic 
visits). 
• 
Women of child bearing potential must be willing to take a urine pregnancy test prior to study 
enrollment, at week 24, and when deemed appropriate by the Investigator and/or Sponsor. 
• 
Individuals of child bearing potential must use an acceptable method of contraception throughout the 
study.  Acceptable methods of birth control include: 
o Oral and other system contraceptives. Individuals must be on a stable use for 3 
months prior to study enrollment. Individuals on oral contraceptives must not alter 
their use, including dose or regimen for the duration of the study 
o Double barrier 
o Bilateral tubal ligation (tubes tied) 
o Partner vasectomy 
o Abstinence 
• 
Be willing to follow study requirements and report any changes in health status or medications, side 
effect symptoms, or reactions immediately. 
• 
Be stable on any medication you are taking for at least 30 days 
 
YOU CANNOT BE ON THE STUDY 
 
If you: 
 
• 
Have been diagnosed with allergies to topical acne products. 
• 
Have a condition and/or disease of the skin that the Investigator deems inappropriate for participation. 
• 
Are a woman who is breastfeeding, pregnant, or planning to become pregnant during the study. 
• 
Have pre-existing or dormant dermatologic conditions on the face (e.g., psoriasis, rosacea, eczema, 
seborrheic dermatitis, severe excoriations etc.) which in the opinion of the Investigator could interfere 
with the outcome of the study. 
• 
Have a history of immunosuppression/immune deficiency disorders (including HIV infection or 
AIDS) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, 
cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, 
Remicade, Stelara.).  
• 
Have an uncontrolled disease such as asthma, diabetes, hypertension, hyperthyroidism, or 
hypothyroidism. Individuals having multiple health conditions may be excluded from participation 
even if the conditions are controlled by diet, medication, etc. at the Investigator’s discretion. 
• 
Are currently participating in another facial usage study or have participated in a clinical trial within 4 
weeks prior to inclusion into the study. 
• 
Have a history of skin cancer on the face within the past 5 years. 
• 
Have any planned surgeries and/or invasive medical procedures during the course of the study. 
• 
Have started hormone replacement therapies (HRT) or hormones for birth control less than 3 months 
prior to study entry or plan on starting, stopping, or changing doses of HRT or hormones for birth 
control during the study. 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
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• 
Have facial sunburn or excessive tanned facial skin or are not willing to avoid daily sun exposure on 
the face and the use of tanning beds or sunless tanning products for the duration of the study. 
• 
Have severe acne, acne conglobata, multiple nodules or cysts (more than 2). 
• 
Are currently taking a natural or prescription testosterone blocker (e.g. saw palmetto, blask cohosh, 
chaste tree, chasteberry, spironolactone, drospirenone, progestins). 
• 
Are currently on a testosterone booster or prescription testosterone (e.g. DHEA, tribulus, testosterone 
cypionate, testosterone enanthate, Sustanon, testosterone propionate, testosterone phenylpropriate, 
Omnadren etc.). 
• 
Are currently taking or have taken within the last 30 days oral or topical prescription medications for 
acne such as Doxycycline, Minocycline, Clindamycin, Bactrim, Tetracycline, Erythromycin, 
Vibramycin and topical tretinoin (Retin A, Renova, Adapalene, Tazarotene), Azelaic acid, benzoyl 
peroxide, Dapsone, Sodium sulfacetamide, Differin, Epiduo. 
• 
Have used oral isotretinoin (Accutane) within the past 6-months. 
• 
Are routinely using (3x a week or more) topical over-the-counter (OTC) acne product (e.g. benzoyl 
peroxide, salicylic acid, alpha hydroxyl, beta hydroxyl and/or poly-hydroxy products or medicated 
cleansers, wipes, masks, scrubs, gels and creams) within 14 days of the study entry. 
• 
Are using or have used any systemic medication considered to affect the course of acne, specifically, 
but not exclusively antibiotics or steroids within the last 30 days prior to entry into the study. 
• 
Have excessive facial hair, including beard, mustache or goatee, or scars, which could interfere with 
evaluations as determined by the Investigator or designee. 
 
WHAT WILL HAPPEN DURING THE STUDY 
 
*Visit 1: Screening (* Visit 1 {Screening} AND Visit 2 {Baseline} may be combined into 1 Visit) 
 
You will: 
 
• 
Be given an IRB-approved Informed Consent Form (ICF), to read and sign. You will be given enough 
time to read the informed consent, and ask questions about the study, and sign 2 copies of this consent 
form. (1 for clinic records, 1 for your records) 
• 
Be given an eligibility and health questionnaire to complete, and assigned a screening number. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Will be screened by the Investigator or designee to see if you qualify for the study. 
• 
If you do qualify for the study, you will: 
o Take a urine pregnancy test (females of child-bearing potential) 
o Have a dermatologist confirm your eligibility 
o Schedule your next appointment. 
 
*Visit 2: Baseline 
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Be screened by the Investigator or designee to see if you still qualify for the study. 
• 
Have your health and eligibility re-reviewed. 
• 
If you still qualify for the study you will: 
o Be assigned a subject number 
o Have photos taken of your face 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
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o Be randomly assigned to receive one of the test products & supporting facial cleanser, 
moisturizer & facial SPF 30  
o Be provided verbal and written usage instructions, and a daily diary to record product use 
o Schedule your next appointment 
 
 
Visits 3, 4 (Week 1, Week 2)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and returned to you. At week 2, your diary 
will be retained by the testing facility and you will be given a new diary 
• 
Have your product collected, weighed, and returned to you 
• 
Schedule your next appointment 
 
Visits 5, 6 (Week 6, Week 12)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Have photos taken of your face 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility and you 
will be given a new diary. 
• 
Have your product collected, weighed, and retained. New products will be dispensed as necessary. 
• 
Schedule your next appointment 
 
Visit 7 (Week 18)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility and you 
will be given a new diary. 
• 
Have your product collected, weighed, and returned to you 
• 
Schedule your next appointment 
 
Visit 8 (Week 24)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Take a urine pregnancy test (females of child-bearing potential). 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Have photos taken of your face 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility. 
• 
Have your product collected, weighed, and retained by the testing facility. 
 
Do not give the study product to other people and keep it out of the reach of children. 
 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
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RISKS OR DISCOMFORTS 
 
If you do not understand what any of these side effects mean, please ask the investigator or study staff to 
explain these terms to you.  
 
Because the study products are investigational, all of their side effects may not be known.  There may be 
rare and unknown side effects. Some of these may be life threatening. 
 
Possible risks associated with the product are, as with any other cosmetic and OTC products, signs of 
irritation including:  
 
• 
Itching 
• 
Burning 
• 
Stinging 
• 
Rash or other allergic reaction 
• 
Tingling 
• 
Scaling/Dryness 
• 
Redness 
 
In some cases, it is possible for a subject to develop allergic reactions to the test material(s). This risk is 
increased for individuals with a history of allergies, and individuals with asthma and/or a history of hives 
may also be affected. Symptoms include rash, hives, and itching. 
 
You must tell the Investigator or study staff about all side effects that you have. If you are not honest 
about your side effects, it may not be safe for you to stay in the study. 
 
BIRTH CONTROL, DANGERS OF PREGNANCY AND BREASTFEEDING 
 
If you are a female, you must not get pregnant while in this study. The only certain way to not get 
pregnant is to not have sex.  If you are a female and choose to have sex, you must use a type of birth 
control.   
 
Even if you use birth control during the study, there is a chance you could become pregnant.  If you are 
pregnant or become pregnant during the study, test products or procedures may involve unforeseeable 
risks to the unborn baby. 
 
A pregnancy test can be wrong.  If you become pregnant during the study, stop using the test products and 
call/inform the Investigator at once. 
 
You cannot be in the study if you are breastfeeding.  It is not known whether the test products are safe for 
breast fed babies.  Therefore if you are breastfeeding a child then it may not be safe for you to participate 
in the study.   
 
POSSIBLE BENEFITS OF THE STUDY 
 
You will not get any medical benefit from being in this study, and there is no promise that your condition 
(acne) will get better.  It might stay the same or it might get worse.  Your participation will provide 
information that may help others. There may be other marketed products that claim to have similar 
benefits. 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
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OTHER OPTIONS TO PARTICIPATING IN THE STUDY   
 
Since this study is for research only, the only other choice would be not to be in the study. 
 
STUDY AND TEST PRODUCT CONFIDENTIALITY 
 
To participate in this study, you must agree to keep any information relating to the design, identity or use 
of these test product samples confidential.  
 
On rare occasions, the sponsor may allow the testing company to disclose to you the name of the test 
products if you are not given this information during the study. This information is typically not provided 
until the end of the study or after the test products have been released for sale to the public. The study 
doctor or study staff will notify you if the sponsor allows us to give you this information. 
 
DISCLOSURE AGREEMENT 
 
This section explains how personal health information collected about you for the study may be used.  
Your personal health information includes, but is not limited to, information that was collected for your 
entry into the study and information that is collected during the study.  The purpose of collecting this 
information is to allow the study staff and the Investigator to conduct the study, to evaluate the sponsor’s 
study products and to analyze the study results.   
 
You may decide not to give permission for the release of your personal health information for the study.  
In that case, you will not be able to participate in the study.   This is because the study staff and/or the 
Investigator would not be able to collect the information needed to evaluate the sponsor’s study products. 
 
People who may inspect your personal and health information includes the Investigator, the Institutional 
Review Board, IntegReview IRB, FDA and other regulatory authorities from the United States or other 
countries, the study sponsor and people that work with the sponsor which includes, monitoring 
committees, contract research organizations, and consultants who have contracts with the company to do 
the study and review the study results. These reviews are done to check on the quality of the study and 
also for other purposes allowed by law. 
 
The results of the study may be published in a medical book or journal, or presented at meetings for 
educational purposes.  Neither your name, nor any other personal health information that specifically 
identifies you, will be used in those materials or presentations.    
 
You may ask the Investigator to see and copy your personal health information related to the study.  You 
may also ask the Investigator to correct any study related information about you that is wrong.  You may 
have to wait until the end of the study to see your study records, so that the study can be organized 
properly.   
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
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This permission to share your personal health information for this study does not have an expiration date.  
If you no longer want to share your personal health information, you may cancel your permission at any 
time by writing to the study staff and/or the Investigator at the address below: 
 
Austin Institute for Clinical Research, Inc. 
302 N. Heatherwilde Blvd., Suite 300 
Pflugerville, TX  78660 
 
If you cancel your permission after you have started in the study, the study staff and the Investigator will 
stop collecting your personal health information.  Although they will stop collecting new information 
about you, they will need to use the information they have already collected to evaluate the study results.  
If you start the study and then cancel your permission, you will not be able to continue to participate in 
the study.  This is because the study staff and/or the Investigator would not be able to collect the 
information needed to evaluate the study.  
 
Austin Institute for Clinical Research, Inc. and the sponsor will make every effort to keep your personal 
health information private.  But after the study staff or the Investigator share your personal health 
information from the study, federal privacy laws may not keep it private.  There might be laws in your 
state or other federal laws that would protect the privacy of this information. 
 
CONFIDENTIALITY  
 
Your records of being in this study will be kept private except when ordered by law.    The following 
people will have access to your study records: 
 
• 
The Investigator 
• 
Sponsor company or research institution [including monitor(s) and auditor(s)] 
• 
Other country, state or federal regulatory agencies 
• 
IntegReview IRB 
 
The Institutional Review Board (IRB), IntegReview, and accrediting agencies may inspect and copy your 
records, which may have your name on them.  Therefore, total confidentiality cannot be guaranteed.  If 
the study results are presented at meetings or printed in publications, your name will not be used. 
  
IN CASE OF STUDY RELATED INJURY 
 
Side effects or complications, both foreseeable and unforeseeable, are possible in any research study 
without any fault to you, the Investigator, the study site, or the study sponsor. If you get hurt or sick as a 
direct result of being in this study, the sponsor will pay the costs of reasonable medical treatment.  To ask 
questions about this, talk to the Investigator or study staff.   
 
The sponsor’s policy does not offer compensation for other expenses.  Be aware that your health care 
payer/insurer might not cover the costs of study-related injuries or illnesses. 
 
Unreimbursed medical expenses not covered by insurance or other third party coverage will be 
reimbursed by the sponsor for medical treatment for any injury that, in the opinion of the study doctor and 
the sponsor, is directly caused by the investigational product or by procedures required by the study 
protocol which would not have been performed as part of your regular medical care. 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
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APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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LEGAL RIGHTS 
 
You will not lose any of your legal rights by signing this consent form. 
 
CONTACT INFORMATION 
 
If you have questions, concerns, or complaints about this study or to report a study related injury, contact: 
 
Edward Lain, MD 
512-279-2545 daytime telephone number  
512-844-4500 after hours number 
 
If you are unable to reach anyone at the number(s) listed above and you need medical attention, 
please go to the nearest emergency room. 
 
If you do not want to talk to the Investigator or study staff, if you have concerns or complaints about the 
research, or to ask questions about your rights as a study subject you may contact IntegReview.  
IntegReview’s policy indicates that all concerns/complaints are to be submitted in writing for review at a 
convened IRB meeting to: 
 
Mailing Address:            OR            Email Address: 
Chairperson 
IntegReview IRB 
3815 S. Capital of Texas Highway 
Suite 320 
Austin, TX  78704 
integreview@integreview.com 
 
If you are unable to provide your concerns/complaints in writing or if this is an emergency situation 
regarding subject safety, contact our office at: 
 
512-326-3001 or 
toll free at 1-877-562-1589 
between 8 a.m. and 5 p.m. Central Time 
 
IntegReview has approved the information in this consent form and has given approval for the 
Investigator to do the study. This does not mean IntegReview has approved your being in the study.  You 
must consider the information in this consent form for yourself and decide if you want to be in this study. 
 
PAYMENT FOR BEING IN THE STUDY 
 
You may receive up to $575.00 for being in the study. You will be paid per completed visit as follows: 
   
Visit 
Compensation (amount) 
Screening/Baseline (Visit 1, 2) 
$40.00 
Visit 3 
$60.00 
Visit 4 
$65.00 
Visit 5 
$75.00 
Visit 6 
$90.00 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
Page 9 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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Visit 7 
$95.00 
Visit 8 
$150.00 
 
If you choose to leave or are withdrawn from the study for any reason before finishing all visits you will 
be paid for each completed visit.  You will receive payment at the end of each study visit. 
 
If you do not qualify for any reason, you will be paid $20.00, which will be mailed to you within 2 weeks 
of the baseline study visit. 
 
If you are paid $600.00 or more by Austin Institute for Clinical Research, Inc. in a calendar year, those 
payments will be reported to the Internal Revenue Service via form 1099-MISC. As required by tax laws, 
if you withhold your social security number, Austin Institute for Clinical Research, Inc. is required to 
withhold 28% of your payment for tax purposes. In this case a form 1099-MISC will be sent to you 
reporting your withholding. 
 
VOLUNTEERING TO BE IN THE STUDY 
 
It is your choice if you want to be in the study.  No one can force you to be in the study.  You may not 
want to be in this study or you may leave the study at any time without penalty or loss of benefits to 
which you are otherwise entitled.   
 
The Investigator, the sponsor company, or IntegReview may take you out of the study without your 
permission, at any time, for the following reasons: 
 
 
• 
If you do not follow the Investigator’s instructions  
• 
If we find out you should not be in the study 
• 
If the study is stopped 
• 
If it becomes harmful to your health 
 
If you leave the study or if you are taken out of the study, you may be asked to return for a final visit to 
have some end of study evaluations or tests.  If information generated from this study is published or 
presented, your identity will not be revealed.  If you leave the study, no more information about you will 
be collected for this study.  However, all of the information you gave us before you left the study will still 
be used.  
 
NEW FINDINGS 
 
If there is new information or any significant new findings that could relate to your willingness to 
continue participation we will tell you.  You can then decide if you still want to be in the study.   
 
THE REASON FOR INSTITUTIONAL REVIEW BOARDS AND INFORMED CONSENT 
 
What is a consent form? 
The informed consent document contains information required by federal regulations.  The informed 
consent document must be approved by an Institutional Review Board (IRB). 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
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APPROVED BY 
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SEPTEMBER 16, 2016 
 
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What is an Institutional Review Board (IRB)? 
An Institutional Review Board (IRB) is a group of people that reviews research studies.  The main goal of 
this review is to protect the rights and well being of the human subjects participating in research studies. 
 
IntegReview, the IRB for this study 
IntegReview is an IRB whose board members provide IRB services across the United States, Canada, 
Japan and Latin America. 
 
To meet requirements of the law, the IntegReview Boards currently include:  
 
• 
Doctors  
• 
Pharmacists  
• 
Nurses  
• 
Toxicologists (people who study the harmful effects of chemicals)  
• 
Other specialists 
• 
Others who do not have a background in science/medicine 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
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APPROVED BY 
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SEPTEMBER 16, 2016 
 
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AGREEMENT TO BE IN THE STUDY 
 
This consent form contains important information to help you decide if you want to be in the study.  If 
you have any questions that are not answered in this consent form, ask one of the study staff.  
 
Please answer YES or NO to the following questions: 
 
A. 
Is this document in a language you understand?  
 
 
 
 
 
 
 
B. 
Do you understand the information in this consent form?  
 
 
 
 
 
 
C. 
Have you been given enough time to ask questions and talk about the study? 
 
 
 
 
D. 
Have all of your questions been answered to your satisfaction? 
 
 
 
 
 
 
E. 
Do you think you received enough information about the study?  
 
 
 
 
 
F. 
Do you volunteer to be in this study of your own free will and without being  
pressured by the Investigator or study staff? 
 
 
 
 
 
 
 
 
G. 
Do you know that you can leave the study at any time without giving 
a reason and without affecting your health care?  
 
 
 
 
 
 
 
H. 
Do you know that your health records from this study may be reviewed 
by the sponsor company and by government authorities?  
 
 
 
 
 
 
I. 
Do you know that you cannot be in another study while you are in this study? 
 
 
 
 
IF YOU ANSWERED “NO” TO ANY OF THE ABOVE QUESTIONS, 
OR YOU ARE UNABLE TO ANSWER ANY OF THE ABOVE QUESTIONS, 
YOU SHOULD NOT SIGN THIS CONSENT FORM. 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
  
 
 
 
 
 
 
 
 
 
 
Printed Name of Person Explaining Consent Form 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Person Explaining Consent Form 
 
 
 
 
 
Date 
 
 
 
You will be given a signed and dated copy of this consent form to keep. 
 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
Page 12 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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Authorization and Release Form 
 
I hereby for good and valuable consideration grant to Austin Institute for Clinical Research, Inc., the 
study sponsor and their respective affiliates, agencies, agents, employees, and assigns (collectively, 
“Authorized Entities”), the unrestricted, royalty free, irrevocable and perpetual right and permission to 
reproduce, 
distribute, 
broadcast 
and/or 
otherwise 
use 
for 
advertising 
and 
other 
commercial/noncommercial purposes:  (i) my name, likeness, image, video, and any other biographical or 
personal information (“Personal Content”); and (ii) any statement or endorsement, or any portions thereof 
(“Testimonial(s)”), made by me relating to the study sponsor’s products (“Products”), in any and all 
media now known or later developed, worldwide in perpetuity, without further compensation or approval 
by me.     
 
I hereby assign to the Authorized Entities all of my world-wide right, title and interest, including my 
copyright interests and all renewals, reissues and extensions thereof, in and to the Personal Content and 
Testimonial(s), including without limitation, any photographic portraits, sound recordings and video 
performances of and/or by me in connection with the Personal Content and/or Testimonial(s).    
  
I am at least 21 years of age, and competent to contract in my own name.  I have read and understand this 
Authorization and Release. 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Person Explaining Release Form 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Person Explaining Release Form 
 
 
 
 
 
Date  
 
 
 
Copy of consent form given to subject on ______________ (date) by ______________ (initials) 
 
You will be given a signed and dated copy of this consent form to keep. 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
Page 13 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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AUTHORIZATION TO USE AND DISCLOSE PERSONAL HEALTH INFORMATION FOR 
RESEARCH 
  
THIS SECTION DESCRIBES YOUR RIGHTS AND HOW PERSONAL HEALTH INFORMATION 
COLLECTED ABOUT YOU DURING THIS STUDY MAY BE USED AND DISCLOSED AND HOW 
YOU CAN GET ACCESS TO THIS INFORMATION.  PLEASE REVIEW IT CAREFULLY. 
  
The United States government has issued a privacy rule to protect the privacy rights of patients.  This rule 
was issued under a law called the Health Insurance Portability and Accountability Act of 1996 
(HIPAA).  The Privacy Rule is designed to protect the confidentiality of your personal health 
information.  The document you are reading, called an “Authorization,” describes your rights and 
explains how your health information will be used and disclosed (shared). 
  
Federal law requires hospitals, researchers and health care providers to protect the privacy of information 
that identifies you and relates to your past, present and future physical and mental health or conditions. 
  
All information collected during the study will be retained by the study doctor and the Study Sponsor, 
except as required by law.  Information from this study will be given to the sponsor.  “Sponsor” includes 
any persons or companies, which are contracted by the sponsor to have access to the research information 
during and after the study.  The information will also be given to the U.S. Food and Drug Administration 
(FDA).  Study records which identify you and the consent form signed by you will be inspected and/or 
copied for research or regulatory purposes by: 
  
• 
Sponsor  
• 
Agents for the sponsor 
• 
The US Food and Drug Administration (FDA) 
• 
Department of Health and Human Services (DHHS) agencies 
• 
IntegReview IRB  
  
Because of the need to release information to these parties, absolute confidentiality cannot be 
guaranteed.  The results of this research study may be presented at meetings or in publications; however, 
your identity will not be disclosed in those presentations. 
  
For purposes of study reporting, you will be identified by your initials and code numbers only.  However, 
your name, date of birth, address, and phone number will be kept on record by the study doctor in case 
you need to be contacted in the future about this study. 
  
After your personal health information is disclosed to the Study Sponsor, the results of the study may be 
reanalyzed at a later date and may be combined with the results of other studies.   The Study Sponsor and 
people who work with the Study Sponsor may use the results of this study for other research purposes, 
including:  
  
• 
Developing a better understanding of the disease; 
• 
Improving the design of future actual use trials 
  
After the study staff or the study doctor discloses your personal health information to others, it could be 
re-disclosed and no longer protected by federal privacy laws. 
  


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
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APPROVED BY 
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SEPTEMBER 16, 2016 
 
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This permission to share your personal health information for this study does not have an expiration 
date.  If you do not withdraw this Authorization in writing, it will remain in effect indefinitely. Your 
study doctor will keep this Authorization for at least 6 years.  If you no longer want to share your personal 
health information, you may cancel your permission at any time by writing to the study staff and/or the 
study doctor at the address below: 
 
Austin Institute for Clinical Research, Inc. 
302 N. Heatherwilde Blvd., Suite 300 
Pflugerville, TX  78660 
 
You have the right to see and get a copy of your records related to the study for as long as the study 
doctor has this information.  However, by signing this Authorization you agree that you might not be able 
to review or receive some of your records related to the study until after the study has been completed. 
  
If you cancel your permission after you have started in the study, the study staff and the study doctor will 
stop collecting your personal health information unless the information concerns an adverse event (a bad 
effect) related to the study.  If an adverse event occurs, your entire medical record may be reviewed.  All 
information that has already been collected for study purposes, and any new information about an adverse 
event related to the study, will be sent to the study sponsor.  Although they will stop collecting new 
information about you, they will need to use the information they have already collected to evaluate the 
study results.  If you start the study and then cancel your permission, you will not be able to continue to 
participate in the study.  This is because the study staff and/or the study doctor would not be able to 
collect the information needed to evaluate the study results. 
  
If you withdraw from the study but do not withdraw your Authorization, new personal health information 
may be collected until this study ends.  
  
You may decide not to give permission for the release of your personal health information for this 
study.  In that case, you will not be able to participate.  This is because the study staff and study doctor 
would not be able to collect the information needed to evaluate the study results. 
  
At the completion of the study, you have the right to access your protected health information that is 
created during this research study that relates to your treatment or to payment, provided such information 
is not exempted under certain laws and regulations.  To request this information, please contact the study 
doctor at the address listed above. 
  
Your Right to Access Health Information 
 
Subject to certain exceptions prescribed by law, you have a right to request access to the health 
information that we hold about you and to request changes if your health information is incorrect or 
incomplete. Any request for access or corrections should be made to the principal doctor conducting this 
study. 
 
Your records obtained while you are in this trial, as well as related health records, will remain strictly 
confidential at all times.  However, these will need to be made available to others working on the 
Sponsor’s behalf, the Independent Ethics Committee members and Medicines Regulatory Authorities. 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Edward Lain, MD 
Informed Consent 
 
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By signing the consent form you agree to this access for the current trial and any further research that may 
be done.  However, the Sponsor will take steps to protect your personal information and will not include 
your name on any sponsor forms, reports, publications, or in any future disclosures.  If you withdraw 
from the study, we will no longer collect your personal information, but we may need to continue to use 
information already collected. 
 
Personal data which may be sensitive (e.g., date of birth) will be collected and processed, but only for 
research purposes in connection with this trial. 
 
The trial data will be sent around the world, but you will not be referred to by name or identified in any 
report or publication nor could the data be traced back to you.  Your data may be transferred to a country 
that does not have the same level of personal data protection as within the United States.  However, 
The Sponsor maintains high standards of confidentiality and protection. 
 
The Sponsor (who will control the use of the data) will take steps to ensure your personal data is 
protected. 
 
By taking part in this trial you agree not to restrict the use of any data even if you withdraw from the trial 
and agree to the transfer of your personal data to other Sponsor companies and to Medicines Regulatory 
Authorities both within and outside of Europe. 
 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
 


APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
INFORMED CONSENT DOCUMENT 
AGREEMENT TO BE IN A RESEARCH STUDY 
 
NAME OF TESTING COMPANY: 
RCTS, Inc., 
 
NUMBER AND TITLE OF STUDY: 
C16-CD020 (GLI.04.SPR.US10354); “A Multi-
Center Clinical Trial to Evaluate the Efficacy of 
Two Acne Treatments” 
 
NAME OF PERSON IN CHARGE OF THE  
RESEARCH STUDY (INVESTIGATOR): 
 
Barry T. Reece, M.S., M.B.A. 
 
 
 
 
 
 
 
Principal Investigator 
 
MEDICAL INVESTIGATORS: 
 
 
Raymond L. Garcia, M.D. 
 
 
 
 
 
 
 
Board Certified Dermatologist  
 
 
 
 
 
 
 
 
Gene Ream, M.D. 
 
 
 
 
 
 
 
Board Certified Dermatologist 
 
TELEPHONE NUMBER(S), DAYTIME: 
 
972-871-7578 
AFTER HOURS:   
972-841-2916 (Emergencies Only, Cell Phone 
Number) 
 
 
INTRODUCTION 
 
You are being invited to volunteer for a clinical research study.  You must read and sign this form before 
you agree to take part in this study.  This form will give you more information about this study.  Please ask 
as many questions as you need to before you decide if you want to be in the study.  You should not sign this 
form if you have any questions that have not been answered. 
 
RCTS, Inc., a contract research organization, is being paid by the sponsor (the company paying for this 
study) to conduct this research study.   
 
You must be honest with the Investigator about your health history or it may not be safe for you to be in this 
study. 
 
PURPOSE OF THE STUDY 
 
The purpose of this study is to evaluate the efficiency of 2 acne treatments for 24 weeks of use in adult 
men and women with mild to moderate facial acne, at least 5 inflammatory lesions, and at least 10 – 100 
non-inflammatory lesions. 
 
HOW LONG THE STUDY WILL LAST AND HOW MANY PEOPLE WILL BE IN THE STUDY 
 
This study will last 24 weeks and have up to 8 visits. At least 100 subjects, men and women between the 
ages of 21-45, are expected to complete this study, with at least 50 subjects completed per cell. Each site 
is to enroll no more than 40 subjects, with at least 100 subjects expected to complete when combined. 
 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
Page 2 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
TO BE IN THIS STUDY 
 
You must: 
 
• 
Be a man or woman age 21 to 45 years at the time of enrollment. 
• 
Have mild to moderate acne on the face as determined by the Investigator or designee. 
• 
Have at least 5 inflammatory lesions as determined by the Investigator or designee. 
• 
Have 10 – 100 non-inflammatory lesions as determined by the Investigator or designee. 
• 
Be willing to use the test products as instructed for 24 weeks.  
• 
Be willing and able to comply with all of the time commitments and procedural requirements of the 
clinical trial protocol. 
• 
Be willing to provide written informed consent including photo release, Health Insurance Portability 
and Accountability Act (HIPAA), and be able to read, speak, write, understand English and be willing 
to share personal information and data, as verified by signing a written authorization at the screening. 
• 
Be willing to withhold all facial treatments during the course of the study including botulinum toxin, 
injectable fillers, microdermabrasion, IPL, peels, facials, laser treatments and tightening treatments.  
Waxing and threading is allowed but not facial laser hair removal. 
• 
Males must be regular shavers and willing to shave on the day of the study visits (prior to clinic 
visits). 
• 
Women of child bearing potential must be willing to take a urine pregnancy test prior to study 
enrollment, at week 24, and when deemed appropriate by the Investigator and/or Sponsor. 
• 
Individuals of child bearing potential must use an acceptable method of contraception throughout the 
study.  Acceptable methods of birth control include: 
o Oral and other system contraceptives. Individuals must be on a stable use for 3 
months prior to study enrollment. Individuals on oral contraceptives must not alter 
their use, including dose or regimen for the duration of the study 
o Double barrier 
o Bilateral tubal ligation (tubes tied) 
o Partner vasectomy 
o Abstinence 
• 
Be willing to follow study requirements and report any changes in health status or medications, side 
effect symptoms, or reactions immediately. 
• 
Be stable on any medication you are taking for at least 30 days 
 
YOU CANNOT BE ON THE STUDY 
 
If you: 
 
• 
Have been diagnosed with allergies to topical acne products. 
• 
Have a condition and/or disease of the skin that the Investigator deems inappropriate for participation. 
• 
Are a woman who is breastfeeding, pregnant, or planning to become pregnant during the study. 
• 
Have pre-existing or dormant dermatologic conditions on the face (e.g., psoriasis, rosacea, eczema, 
seborrheic dermatitis, severe excoriations etc.) which in the opinion of the Investigator could interfere 
with the outcome of the study. 
• 
Have a history of immunosuppression/immune deficiency disorders (including HIV infection or 
AIDS) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
Page 3 of 15 
APPROVED BY 
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FEBRUARY 25, 2016 
 
cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, 
Remicade, Stelara.).  
• 
Have an uncontrolled disease such as asthma, diabetes, hypertension, hyperthyroidism, or 
hypothyroidism. Individuals having multiple health conditions may be excluded from participation 
even if the conditions are controlled by diet, medication, etc. at the Investigator’s discretion. 
• 
Are currently participating in another facial usage study or have participated in a clinical trial within 4 
weeks prior to inclusion into the study. 
• 
Have a history of skin cancer on the face within the past 5 years. 
• 
Have any planned surgeries and/or invasive medical procedures during the course of the study. 
• 
Have started hormone replacement therapies (HRT) or hormones for birth control less than 3 months 
prior to study entry or plan on starting, stopping, or changing doses of HRT or hormones for birth 
control during the study. 
• 
Have facial sunburn or excessive tanned facial skin or are not willing to avoid daily sun exposure on 
the face and the use of tanning beds or sunless tanning products for the duration of the study. 
• 
Have severe acne, acne conglobata, multiple nodules or cysts (more than 2). 
• 
Are currently taking a natural or prescription testosterone blocker (e.g. saw palmetto, blask cohosh, 
chaste tree, chasteberry, spironolactone, drospirenone, progestins). 
• 
Are currently on a testosterone booster or prescription testosterone (e.g. DHEA, tribulus, testosterone 
cypionate, testosterone enanthate, Sustanon, testosterone propionate, testosterone phenylpropriate, 
Omnadren etc.). 
• 
Are currently taking or have taken within the last 30 days oral or topical prescription medications for 
acne such as Doxycycline, Minocycline, Clindamycin, Bactrim, Tetracycline, Erythromycin, 
Vibramycin and topical tretinoin (Retin A, Renova, Adapalene, Tazarotene), Azelaic acid, benzoyl 
peroxide, Dapsone, Sodium sulfacetamide, Differin, Epiduo. 
• 
Have used oral isotretinoin (Accutane) within the past 6-months. 
• 
Are routinely using (3x a week or more) topical over-the-counter (OTC) acne product (e.g. benzoyl 
peroxide, salicylic acid, alpha hydroxyl, beta hydroxyl and/or poly-hydroxy products or medicated 
cleansers, wipes, masks, scrubs, gels and creams) within 14 days of the study entry. 
• 
Are using or have used any systemic medication considered to affect the course of acne, specifically, 
but not exclusively antibiotics or steroids within the last 30 days prior to entry into the study. 
• 
Have excessive facial hair, including beard, mustache or goatee, or scars, which could interfere with 
evaluations as determined by the Investigator or designee. 
 
WHAT WILL HAPPEN DURING THE STUDY 
 
*Visit 1: Screening (* Visit 1 {Screening} AND Visit 2 {Baseline} may be combined into 1 Visit) 
 
You will: 
 
• 
Be given an IRB-approved Informed Consent Form (ICF), to read and sign. You will be given enough 
time to read the informed consent, and ask questions about the study, and sign 1 copy of this consent 
form and be given a signed photocopy to keep for your records. 
• 
Be given an eligibility and health questionnaire to complete, and assigned a screening number. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Will be screened by the Investigator or designee to see if you qualify for the study. 
• 
If you do qualify for the study, you will: 
o Take a urine pregnancy test (females of child-bearing potential) 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
Page 4 of 15 
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FEBRUARY 25, 2016 
 
o Have a trained evaluator confirm your eligibility 
o Schedule your next appointment. 
 
*Visit 2: Baseline 
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Be screened by the Investigator or designee to see if you still qualify for the study. 
• 
Have your health and eligibility re-reviewed. 
• 
If you still qualify for the study you will: 
o Be assigned a subject number 
o Have photos taken of your face 
o Be randomly assigned to receive one of the test products & supporting facial cleanser, 
moisturizer & facial SPF 30  
o Be provided verbal and written usage instructions, and a daily diary to record product use 
o Schedule your next appointment 
 
 
Visits 3, 4 (Week 1, Week 2)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and returned to you. At week 2, your diary 
will be retained by the testing facility and you will be given a new diary 
• 
Have your product collected, weighed, and returned to you 
• 
Schedule your next appointment 
 
Visits 5, 6 (Week 6, Week 12)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Have photos taken of your face 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility and you 
will be given a new diary. 
• 
Have your product collected, weighed, and retained. New products will be dispensed as necessary. 
• 
Schedule your next appointment 
 
Visit 7 (Week 18)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility and you 
will be given a new diary. 
• 
Have your product collected, weighed, and returned to you 
• 
Schedule your next appointment 
 
Visit 8 (Week 24)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Take a urine pregnancy test (females of child-bearing potential). 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
Page 5 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Have photos taken of your face 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility. 
• 
Have your product collected, weighed, and retained by the testing facility. 
 
Do not give the study product to other people and keep it out of the reach of children. 
 
RISKS OR DISCOMFORTS 
 
If you do not understand what any of these side effects mean, please ask the investigator or study staff to 
explain these terms to you.  
 
Because the study products are investigational, all of their side effects may not be known.  There may be 
rare and unknown side effects. Some of these may be life threatening. 
 
Possible risks associated with the product are, as with any other cosmetic and OTC products, signs of 
irritation including:  
 
• 
Itching 
• 
Burning 
• 
Stinging 
• 
Rash or other allergic reaction 
• 
Tingling 
• 
Scaling/Dryness 
• 
Redness 
 
In some cases, it is possible for a subject to develop allergic reactions to the test material(s). This risk is 
increased for individuals with a history of allergies, and individuals with asthma and/or a history of hives 
may also be affected. Symptoms include rash, hives, and itching. 
 
You must tell the Investigator or study staff about all side effects that you have. If you are not honest 
about your side effects, it may not be safe for you to stay in the study. 
 
BIRTH CONTROL, DANGERS OF PREGNANCY AND BREASTFEEDING 
 
If you are a female, you must not get pregnant while in this study. The only certain way to not get 
pregnant is to not have sex.  If you are a female and choose to have sex, you must use a type of birth 
control.   
 
Even if you use birth control during the study, there is a chance you could become pregnant.  If you are 
pregnant or become pregnant during the study, test products or procedures may involve unforeseeable 
risks to the unborn baby. 
 
A pregnancy test can be wrong.  If you become pregnant during the study, stop using the test products and 
call/inform the Investigator at once. 
 
You cannot be in the study if you are breastfeeding.  It is not known whether the test products are safe for 
breast fed babies.  Therefore if you are breastfeeding a child then it may not be safe for you to participate 
in the study.   
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
Page 6 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
POSSIBLE BENEFITS OF THE STUDY 
 
You will not get any medical benefit from being in this study, and there is no promise that your condition 
(acne) will get better.  It might stay the same or it might get worse.  Your participation will provide 
information that may help others. There may be other marketed products that claim to have similar 
benefits. 
 
OTHER OPTIONS TO PARTICIPATING IN THE STUDY   
 
Since this study is for research only, the only other choice would be not to be in the study. 
 
STUDY AND TEST PRODUCT CONFIDENTIALITY 
 
To participate in this study, you must agree to keep any information relating to the design, identity or use 
of these test product samples confidential.  
 
On rare occasions, the sponsor may allow the testing company to disclose to you the name of the test 
products if you are not given this information during the study. This information is typically not provided 
until the end of the study or after the test products have been released for sale to the public. The study 
doctor or study staff will notify you if the sponsor allows us to give you this information. 
 
DISCLOSURE AGREEMENT 
 
This section explains how personal health information collected about you for the study may be used.  
Your personal health information includes, but is not limited to, information that was collected for your 
entry into the study and information that is collected during the study.  The purpose of collecting this 
information is to allow the study staff and the Investigator to conduct the study, to evaluate the sponsor’s 
study products and to analyze the study results.   
 
You may decide not to give permission for the release of your personal health information for the study.  
In that case, you will not be able to participate in the study.   This is because the study staff and/or the 
Investigator would not be able to collect the information needed to evaluate the sponsor’s study products. 
 
People who may inspect your personal and health information includes the Investigator, the Institutional 
Review Board, IntegReview IRB, FDA and other regulatory authorities from the United States or other 
countries, the study sponsor and people that work with the sponsor which includes, monitoring 
committees, contract research organizations, and consultants who have contracts with the company to do 
the study and review the study results. These reviews are done to check on the quality of the study and 
also for other purposes allowed by law. 
 
The results of the study may be published in a medical book or journal, or presented at meetings for 
educational purposes.  Neither your name, nor any other personal health information that specifically 
identifies you, will be used in those materials or presentations.    
 
You may ask the Investigator to see and copy your personal health information related to the study.  You 
may also ask the Investigator to correct any study related information about you that is wrong.  You may 
have to wait until the end of the study to see your study records, so that the study can be organized 
properly.   
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
Page 7 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
This permission to share your personal health information for this study does not have an expiration date.  
If you no longer want to share your personal health information, you may cancel your permission at any 
time by writing to the study staff and/or the Investigator at the address below: 
 
Barry T. Reece 
3207 Esters Road 
Irving, Texas 75062 
 
If you cancel your permission after you have started in the study, the study staff and the Investigator will 
stop collecting your personal health information.  Although they will stop collecting new information 
about you, they will need to use the information they have already collected to evaluate the study results.  
If you start the study and then cancel your permission, you will not be able to continue to participate in 
the study.  This is because the study staff and/or the Investigator would not be able to collect the 
information needed to evaluate the study.  
 
RCTS, Inc., and the sponsor will make every effort to keep your personal health information private.  But 
after the study staff or the Investigator share your personal health information from the study, federal 
privacy laws may not keep it private.  There might be laws in your state or other federal laws that would 
protect the privacy of this information. 
 
CONFIDENTIALITY  
 
Your records of being in this study will be kept private except when ordered by law.    The following 
people will have access to your study records: 
 
• 
The Investigator 
• 
Sponsor company or research institution [including monitor(s) and auditor(s)] 
• 
Other country, state or federal regulatory agencies 
• 
IntegReview IRB 
 
The Institutional Review Board (IRB), IntegReview, and accrediting agencies may inspect and copy your 
records, which may have your name on them.  Therefore, total confidentiality cannot be guaranteed.  If 
the study results are presented at meetings or printed in publications, your name will not be used. 
  
IN CASE OF STUDY RELATED INJURY 
 
Side effects or complications, both foreseeable and unforeseeable, are possible in any research study 
without any fault to you, the Investigator, the study site, or the study sponsor. If you get hurt or sick as a 
direct result of being in this study, the sponsor will pay the costs of reasonable medical treatment.  To ask 
questions about this, talk to the Investigator or study staff.   
 
The sponsor’s policy does not offer compensation for other expenses.  Be aware that your health care 
payer/insurer might not cover the costs of study-related injuries or illnesses. 
Unreimbursed medical expenses not covered by insurance or other third party coverage will be 
reimbursed by the sponsor for medical treatment for any injury that, in the opinion of the study doctor and 
the sponsor, is directly caused by the investigational product or by procedures required by the study 
protocol which would not have been performed as part of your regular medical care. 
 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
Page 8 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
LEGAL RIGHTS 
 
You will not lose any of your legal rights by signing this consent form. 
 
CONTACT INFORMATION 
 
If you have questions, concerns, or complaints about this study or to report a study related injury, contact: 
 
Barry T. Reece 
972-871-7578 daytime telephone number  
972-841-2916 after hours number (cell phone) 
 
If you are unable to reach anyone at the number(s) listed above and you need medical attention, 
please go to the nearest emergency room. 
 
If you do not want to talk to the Investigator or study staff, if you have concerns or complaints about the 
research, or to ask questions about your rights as a study subject you may contact IntegReview.  
IntegReview’s policy indicates that all concerns/complaints are to be submitted in writing for review at a 
convened IRB meeting to: 
 
Mailing Address:            OR            Email Address: 
Chairperson 
IntegReview IRB 
3815 S. Capital of Texas Highway 
Suite 320 
Austin, TX  78704 
integreview@integreview.com 
 
If you are unable to provide your concerns/complaints in writing or if this is an emergency situation 
regarding subject safety, contact our office at: 
 
512-326-3001 or 
toll free at 1-877-562-1589 
between 8 a.m. and 5 p.m. Central Time 
 
IntegReview has approved the information in this consent form and has given approval for the 
Investigator to do the study. This does not mean IntegReview has approved your being in the study.  You 
must consider the information in this consent form for yourself and decide if you want to be in this study. 
 
PAYMENT FOR BEING IN THE STUDY 
 
You may receive up to $600.00 for being in the study. You will be paid per completed visit as follows: 
   
Visit 
Compensation (amount) 
Visit 1: Screening 
$25.00 
Visit 2: Baseline 
$50.00 
Visit 3: Week 1 
$50.00 
Visit 4: Week 2 
$50.00 
Visit 5: Week 6 
$50.00 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
Page 9 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
Visit 6: Week 12 
$50.00 
Visit 7: Week 18 
$50.00 
Visit 8: Week 24 
$50.00 
Bonus for completing all visits: 
$225.00 
 
If you choose to leave or are withdrawn from the study for any reason before finishing all visits you will 
be paid for each completed visit.  You will receive payment on the originally scheduled last day of the 
study. 
 
If you are paid $600.00 or more by RCTS, Inc., in a calendar year, those payments will be reported to the 
Internal Revenue Service via form 1099-MISC. As required by tax laws, if you withhold your social 
security number, RCTS, Inc. is required to withhold 28% of your payment for tax purposes. In this case a 
form 1099-MISC will be sent to you reporting your withholding. 
 
VOLUNTEERING TO BE IN THE STUDY 
 
It is your choice if you want to be in the study.  No one can force you to be in the study.  You may not 
want to be in this study or you may leave the study at any time without penalty or loss of benefits to 
which you are otherwise entitled.   
 
The Investigator, the sponsor company, or IntegReview may take you out of the study without your 
permission, at any time, for the following reasons: 
 
 
• 
If you do not follow the Investigator’s instructions  
• 
If we find out you should not be in the study 
• 
If the study is stopped 
• 
If it becomes harmful to your health 
 
If you leave the study or if you are taken out of the study, you may be asked to return for a final visit to 
have some end of study evaluations or tests.  If information generated from this study is published or 
presented, your identity will not be revealed.  If you leave the study, no more information about you will 
be collected for this study.  However, all of the information you gave us before you left the study will still 
be used.  
 
NEW FINDINGS 
 
If there is new information or any significant new findings that could relate to your willingness to 
continue participation we will tell you.  You can then decide if you still want to be in the study.   
 
THE REASON FOR INSTITUTIONAL REVIEW BOARDS AND INFORMED CONSENT 
 
What is a consent form? 
The informed consent document contains information required by federal regulations.  The informed 
consent document must be approved by an Institutional Review Board (IRB). 
 
What is an Institutional Review Board (IRB)? 
An Institutional Review Board (IRB) is a group of people that reviews research studies.  The main goal of 
this review is to protect the rights and well being of the human subjects participating in research studies. 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
Page 10 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
IntegReview, the IRB for this study 
IntegReview is an IRB whose board members provide IRB services across the United States, Canada, 
Japan and Latin America. 
 
To meet requirements of the law, the IntegReview Boards currently include:  
 
• 
Doctors  
• 
Pharmacists  
• 
Nurses  
• 
Toxicologists (people who study the harmful effects of chemicals)  
• 
Other specialists 
• 
Others who do not have a background in science/medicine 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
Page 11 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
AGREEMENT TO BE IN THE STUDY 
 
This consent form contains important information to help you decide if you want to be in the study.  If 
you have any questions that are not answered in this consent form, ask one of the study staff.  
 
Please answer YES or NO to the following questions: 
 
A. 
Is this document in a language you understand?  
 
 
 
 
 
 
 
B. 
Do you understand the information in this consent form?  
 
 
 
 
 
 
C. 
Have you been given enough time to ask questions and talk about the study? 
 
 
 
 
D. 
Have all of your questions been answered to your satisfaction? 
 
 
 
 
 
 
E. 
Do you think you received enough information about the study?  
 
 
 
 
 
F. 
Do you volunteer to be in this study of your own free will and without being  
pressured by the Investigator or study staff? 
 
 
 
 
 
 
 
 
G. 
Do you know that you can leave the study at any time without giving 
a reason and without affecting your health care?  
 
 
 
 
 
 
 
H. 
Do you know that your health records from this study may be reviewed 
by the sponsor company and by government authorities?  
 
 
 
 
 
 
I. 
Do you know that you cannot be in another study while you are in this study? 
 
 
 
 
IF YOU ANSWERED “NO” TO ANY OF THE ABOVE QUESTIONS, 
OR YOU ARE UNABLE TO ANSWER ANY OF THE ABOVE QUESTIONS, 
YOU SHOULD NOT SIGN THIS CONSENT FORM. 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
  
 
 
 
 
 
 
 
 
 
 
Printed Name of Person Explaining Consent Form 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Person Explaining Consent Form 
 
 
 
 
 
Date 
 
 
 
You will be given a signed and dated copy of this consent form to keep. 
 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
Page 12 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
Authorization and Photographic Release Form 
 
I hereby for good and valuable consideration grant to RCTS, Inc.,  the study sponsor and their respective 
affiliates, agencies, agents, employees, and assigns (collectively, “Authorized Entities”), the unrestricted, 
royalty free, irrevocable and perpetual right and permission to reproduce, distribute, broadcast and/or 
otherwise use for advertising and other commercial/noncommercial purposes:  (i) my name, likeness, 
image, video, and any other biographical or personal information (“Personal Content”); and (ii) any 
statement or endorsement, or any portions thereof (“Testimonial(s)”), made by me relating to the study 
sponsor’s products (“Products”), in any and all media now known or later developed, worldwide in 
perpetuity, without further compensation or approval by me. 
 
I hereby assign to the Authorized Entities all of my world-wide right, title and interest, including my 
copyright interests and all renewals, reissues and extensions thereof, in and to the Personal Content and 
Testimonial(s), including without limitation, any photographic portraits, sound recordings and video 
performances of and/or by me in connection with the Personal Content and/or Testimonial(s).    
  
I am at least 21 years of age, and competent to contract in my own name.  I have read and understand this 
Authorization and Release. 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Person Explaining Release Form 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Person Explaining Release Form 
 
 
 
 
 
Date  
 
 
 
Copy of consent form given to subject on ______________ (date) by ______________ (initials) 
 
You will be given a signed and dated copy of this consent form to keep. 
 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
Page 13 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
AUTHORIZATION TO USE AND DISCLOSE PERSONAL HEALTH INFORMATION FOR 
RESEARCH 
  
THIS SECTION DESCRIBES YOUR RIGHTS AND HOW PERSONAL HEALTH INFORMATION 
COLLECTED ABOUT YOU DURING THIS STUDY MAY BE USED AND DISCLOSED AND HOW 
YOU CAN GET ACCESS TO THIS INFORMATION.  PLEASE REVIEW IT CAREFULLY. 
  
The United States government has issued a privacy rule to protect the privacy rights of patients.  This rule 
was issued under a law called the Health Insurance Portability and Accountability Act of 1996 
(HIPAA).  The Privacy Rule is designed to protect the confidentiality of your personal health 
information.  The document you are reading, called an “Authorization,” describes your rights and 
explains how your health information will be used and disclosed (shared). 
  
Federal law requires hospitals, researchers and health care providers to protect the privacy of information 
that identifies you and relates to your past, present and future physical and mental health or conditions. 
  
All information collected during the study will be retained by the study doctor and the Study Sponsor, 
except as required by law.  Information from this study will be given to the sponsor.  “Sponsor” includes 
any persons or companies, which are contracted by the sponsor to have access to the research information 
during and after the study.  The information will also be given to the U.S. Food and Drug Administration 
(FDA).  Study records which identify you and the consent form signed by you will be inspected and/or 
copied for research or regulatory purposes by: 
  
• 
Sponsor  
• 
Agents for the sponsor 
• 
The US Food and Drug Administration (FDA) 
• 
Department of Health and Human Services (DHHS) agencies 
• 
IntegReview IRB  
  
Because of the need to release information to these parties, absolute confidentiality cannot be 
guaranteed.  The results of this research study may be presented at meetings or in publications; however, 
your identity will not be disclosed in those presentations. 
  
For purposes of study reporting, you will be identified by your initials and code numbers only.  However, 
your name, date of birth, address, and phone number will be kept on record by the study doctor in case 
you need to be contacted in the future about this study. 
  
After your personal health information is disclosed to the Study Sponsor, the results of the study may be 
reanalyzed at a later date and may be combined with the results of other studies.   The Study Sponsor and 
people who work with the Study Sponsor may use the results of this study for other research purposes, 
including:  
  
• 
Developing a better understanding of the disease; 
• 
Improving the design of future actual use trials 
  
After the study staff or the study doctor discloses your personal health information to others, it could be 
re-disclosed and no longer protected by federal privacy laws. 
  
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
Page 14 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
This permission to share your personal health information for this study does not have an expiration 
date.  If you do not withdraw this Authorization in writing, it will remain in effect indefinitely. Your 
study doctor will keep this Authorization for at least 6 years.  If you no longer want to share your personal 
health information, you may cancel your permission at any time by writing to the study staff and/or the 
study doctor at the address below: 
 
RCTS, Inc., 
3207 Esters Road 
Irving, Texas, 75062 
 
You have the right to see and get a copy of your records related to the study for as long as the study 
doctor has this information.  However, by signing this Authorization you agree that you might not be able 
to review or receive some of your records related to the study until after the study has been completed. 
  
If you cancel your permission after you have started in the study, the study staff and the study doctor will 
stop collecting your personal health information unless the information concerns an adverse event (a bad 
effect) related to the study.  If an adverse event occurs, your entire medical record may be reviewed.  All 
information that has already been collected for study purposes, and any new information about an adverse 
event related to the study, will be sent to the study sponsor.  Although they will stop collecting new 
information about you, they will need to use the information they have already collected to evaluate the 
study results.  If you start the study and then cancel your permission, you will not be able to continue to 
participate in the study.  This is because the study staff and/or the study doctor would not be able to 
collect the information needed to evaluate the study results. 
  
If you withdraw from the study but do not withdraw your Authorization, new personal health information 
may be collected until this study ends.  
  
You may decide not to give permission for the release of your personal health information for this 
study.  In that case, you will not be able to participate.  This is because the study staff and study doctor 
would not be able to collect the information needed to evaluate the study results. 
  
At the completion of the study, you have the right to access your protected health information that is 
created during this research study that relates to your treatment or to payment, provided such information 
is not exempted under certain laws and regulations.  To request this information, please contact the study 
doctor at the address listed above. 
  
Your Right to Access Health Information 
 
Subject to certain exceptions prescribed by law, you have a right to request access to the health 
information that we hold about you and to request changes if your health information is incorrect or 
incomplete. Any request for access or corrections should be made to the principal doctor conducting this 
study. 
 
Your records obtained while you are in this trial, as well as related health records, will remain strictly 
confidential at all times.  However, these will need to be made available to others working on the 
Sponsor’s behalf, the Independent Ethics Committee members and Medicines Regulatory Authorities. 
 
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Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
Page 15 of 15 
APPROVED BY 
INTEGREVIEW IRB 
FEBRUARY 25, 2016 
 
By signing the consent form you agree to this access for the current trial and any further research that may 
be done.  However, the Sponsor will take steps to protect your personal information and will not include 
your name on any sponsor forms, reports, publications, or in any future disclosures.  If you withdraw 
from the study, we will no longer collect your personal information, but we may need to continue to use 
information already collected. 
 
Personal data which may be sensitive (e.g., date of birth) will be collected and processed, but only for 
research purposes in connection with this trial. 
 
The trial data will be sent around the world, but you will not be referred to by name or identified in any 
report or publication nor could the data be traced back to you.  Your data may be transferred to a country 
that does not have the same level of personal data protection as within the United States.  However, 
The Sponsor maintains high standards of confidentiality and protection. 
 
The Sponsor (who will control the use of the data) will take steps to ensure your personal data is 
protected. 
 
By taking part in this trial you agree not to restrict the use of any data even if you withdraw from the trial 
and agree to the transfer of your personal data to other Sponsor companies and to Medicines Regulatory 
Authorities both within and outside of Europe. 
 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
 
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APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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INFORMED CONSENT DOCUMENT 
AGREEMENT TO BE IN A RESEARCH STUDY 
 
NAME OF TESTING COMPANY: 
RCTS, Inc., 
 
NUMBER AND TITLE OF STUDY: 
C16-CD020 (GLI.04.SPR.US10354); “A Multi-
Center Clinical Trial to Evaluate the Efficacy of 
Two Acne Treatments” 
 
NAME OF PERSON IN CHARGE OF THE  
RESEARCH STUDY (INVESTIGATOR): 
 
Barry T. Reece, M.S., M.B.A. 
 
 
 
 
 
 
 
Principal Investigator 
 
MEDICAL INVESTIGATORS: 
 
 
Raymond L. Garcia, M.D. 
 
 
 
 
 
 
 
Board Certified Dermatologist  
 
 
 
 
 
 
 
 
Gene Ream, M.D. 
 
 
 
 
 
 
 
Board Certified Dermatologist 
 
TELEPHONE NUMBER(S), DAYTIME: 
 
972-871-7578 
AFTER HOURS:   
972-841-2916 (Emergencies Only, Cell Phone 
Number) 
 
 
INTRODUCTION 
 
You are being invited to volunteer for a clinical research study.  You must read and sign this form before 
you agree to take part in this study.  This form will give you more information about this study.  Please ask 
as many questions as you need to before you decide if you want to be in the study.  You should not sign this 
form if you have any questions that have not been answered. 
 
RCTS, Inc., a contract research organization, is being paid by the sponsor (the company paying for this 
study) to conduct this research study.   
 
You must be honest with the Investigator about your health history or it may not be safe for you to be in this 
study. 
 
PURPOSE OF THE STUDY 
 
The purpose of this study is to evaluate the efficiency of 2 acne treatments for 24 weeks of use in adult 
men and women with mild to moderate facial acne, at least 5 inflammatory lesions, and at least 10 – 100 
non-inflammatory lesions. 
 
HOW LONG THE STUDY WILL LAST AND HOW MANY PEOPLE WILL BE IN THE STUDY 
 
This study will last 24 weeks and have up to 8 visits. At least 100 subjects, men and women between the 
ages of 21-45, are expected to complete this study, with at least 50 subjects completed per cell.  
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
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TO BE IN THIS STUDY 
 
You must: 
 
• 
Be a man or woman age 21 to 45 years at the time of enrollment. 
• 
Have mild to moderate acne on the face as determined by the Investigator or designee. 
• 
Have at least 5 inflammatory lesions as determined by the Investigator or designee. 
• 
Have 10 – 100 non-inflammatory lesions as determined by the Investigator or designee. 
• 
Be willing to use the test products as instructed for 24 weeks.  
• 
Be willing and able to comply with all of the time commitments and procedural requirements of the 
clinical trial protocol. 
• 
Be willing to provide written informed consent including photo release, Health Insurance Portability 
and Accountability Act (HIPAA), and be able to read, speak, write, understand English and be willing 
to share personal information and data, as verified by signing a written authorization at the screening. 
• 
Be willing to withhold all facial treatments during the course of the study including botulinum toxin, 
injectable fillers, microdermabrasion, IPL, peels, facials, laser treatments and tightening treatments.  
Waxing and threading is allowed but not facial laser hair removal. 
• 
Males must be regular shavers and willing to shave on the day of the study visits (prior to clinic 
visits). 
• 
Women of child bearing potential must be willing to take a urine pregnancy test prior to study 
enrollment, at week 24, and when deemed appropriate by the Investigator and/or Sponsor. 
• 
Individuals of child bearing potential must use an acceptable method of contraception throughout the 
study.  Acceptable methods of birth control include: 
o Oral and other system contraceptives. Individuals must be on a stable use for 3 
months prior to study enrollment. Individuals on oral contraceptives must not alter 
their use, including dose or regimen for the duration of the study 
o Double barrier 
o Bilateral tubal ligation (tubes tied) 
o Partner vasectomy 
o Abstinence 
• 
Be willing to follow study requirements and report any changes in health status or medications, side 
effect symptoms, or reactions immediately. 
• 
Be stable on any medication you are taking for at least 30 days 
 
YOU CANNOT BE ON THE STUDY 
 
If you: 
 
• 
Have been diagnosed with allergies to topical acne products. 
• 
Have a condition and/or disease of the skin that the Investigator deems inappropriate for participation. 
• 
Are a woman who is breastfeeding, pregnant, or planning to become pregnant during the study. 
• 
Have pre-existing or dormant dermatologic conditions on the face (e.g., psoriasis, rosacea, eczema, 
seborrheic dermatitis, severe excoriations etc.) which in the opinion of the Investigator could interfere 
with the outcome of the study. 
 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
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• 
Have a history of immunosuppression/immune deficiency disorders (including HIV infection or 
AIDS) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, 
cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, 
Remicade, Stelara.).  
• 
Have an uncontrolled disease such as asthma, diabetes, hypertension, hyperthyroidism, or 
hypothyroidism. Individuals having multiple health conditions may be excluded from participation 
even if the conditions are controlled by diet, medication, etc. at the Investigator’s discretion. 
• 
Are currently participating in another facial usage study or have participated in a clinical trial within 4 
weeks prior to inclusion into the study. 
• 
Have a history of skin cancer on the face within the past 5 years. 
• 
Have any planned surgeries and/or invasive medical procedures during the course of the study. 
• 
Have started hormone replacement therapies (HRT) or hormones for birth control less than 3 months 
prior to study entry or plan on starting, stopping, or changing doses of HRT or hormones for birth 
control during the study. 
• 
Have facial sunburn or excessive tanned facial skin or are not willing to avoid daily sun exposure on 
the face and the use of tanning beds or sunless tanning products for the duration of the study. 
• 
Have severe acne, acne conglobata, multiple nodules or cysts (more than 2). 
• 
Are currently taking a natural or prescription testosterone blocker (e.g. saw palmetto, blask cohosh, 
chaste tree, chasteberry, spironolactone, drospirenone, progestins). 
• 
Are currently on a testosterone booster or prescription testosterone (e.g. DHEA, tribulus, testosterone 
cypionate, testosterone enanthate, Sustanon, testosterone propionate, testosterone phenylpropriate, 
Omnadren etc.). 
• 
Are currently taking or have taken within the last 30 days oral or topical prescription medications for 
acne such as Doxycycline, Minocycline, Clindamycin, Bactrim, Tetracycline, Erythromycin, 
Vibramycin and topical tretinoin (Retin A, Renova, Adapalene, Tazarotene), Azelaic acid, benzoyl 
peroxide, Dapsone, Sodium sulfacetamide, Differin, Epiduo. 
• 
Have used oral isotretinoin (Accutane) within the past 6-months. 
• 
Are routinely using (3x a week or more) topical over-the-counter (OTC) acne product (e.g. benzoyl 
peroxide, salicylic acid, alpha hydroxyl, beta hydroxyl and/or poly-hydroxy products or medicated 
cleansers, wipes, masks, scrubs, gels and creams) within 14 days of the study entry. 
• 
Are using or have used any systemic medication considered to affect the course of acne, specifically, 
but not exclusively antibiotics or steroids within the last 30 days prior to entry into the study. 
• 
Have excessive facial hair, including beard, mustache or goatee, or scars, which could interfere with 
evaluations as determined by the Investigator or designee. 
 
WHAT WILL HAPPEN DURING THE STUDY 
 
*Visit 1: Screening (* Visit 1 {Screening} AND Visit 2 {Baseline} may be combined into 1 Visit) 
 
You will: 
 
• 
Be given an IRB-approved Informed Consent Form (ICF), to read and sign. You will be given enough 
time to read the informed consent, and ask questions about the study, and sign 1 copy of this consent 
form and be given a signed photocopy to keep for your records. 
• 
Be given an eligibility and health questionnaire to complete, and assigned a screening number. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Will be screened by the Investigator or designee to see if you qualify for the study. 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
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• 
If you do qualify for the study, you will: 
o Take a urine pregnancy test (females of child-bearing potential) 
o Have a trained evaluator confirm your eligibility 
o Schedule your next appointment. 
 
*Visit 2: Baseline 
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Be screened by the Investigator or designee to see if you still qualify for the study. 
• 
Have your health and eligibility re-reviewed. 
• 
If you still qualify for the study you will: 
o Be assigned a subject number 
o Have photos taken of your face 
o Be randomly assigned to receive one of the test products & supporting facial cleanser, 
moisturizer & facial SPF 30  
o Be provided verbal and written usage instructions, and a daily diary to record product use 
o Schedule your next appointment 
 
 
Visits 3, 4 (Week 1, Week 2)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and returned to you. At week 2, your diary 
will be retained by the testing facility and you will be given a new diary 
• 
Have your product collected, weighed, and returned to you 
• 
Schedule your next appointment 
 
Visits 5, 6 (Week 6, Week 12)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Have photos taken of your face 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility and you 
will be given a new diary. 
• 
Have your product collected, weighed, and retained. New products will be dispensed as necessary. 
• 
Schedule your next appointment 
 
Visit 7 (Week 18)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility and you 
will be given a new diary. 
• 
Have your product collected, weighed, and returned to you 
• 
Schedule your next appointment 
 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
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APPROVED BY 
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Visit 8 (Week 24)  
• 
Be asked if you have experienced any changes in your health since the previous visit. 
• 
Take a urine pregnancy test (females of child-bearing potential). 
• 
Will acclimate for 15 minutes in a room at 68-750F and 35-65% humidity. 
• 
Have your face examined by the Investigator or designee 
• 
Have photos taken of your face 
• 
Complete a self-assessment questionnaire 
• 
Have your diary collected and reviewed for compliance, and retained by the testing facility. 
• 
Have your product collected, weighed, and retained by the testing facility. 
 
Do not give the study product to other people and keep it out of the reach of children. 
 
RISKS OR DISCOMFORTS 
 
If you do not understand what any of these side effects mean, please ask the investigator or study staff to 
explain these terms to you.  
 
Because the study products are investigational, all of their side effects may not be known.  There may be 
rare and unknown side effects. Some of these may be life threatening. 
 
Possible risks associated with the product are, as with any other cosmetic and OTC products, signs of 
irritation including:  
 
• 
Itching 
• 
Burning 
• 
Stinging 
• 
Rash or other allergic reaction 
• 
Tingling 
• 
Scaling/Dryness 
• 
Redness 
 
In some cases, it is possible for a subject to develop allergic reactions to the test material(s). This risk is 
increased for individuals with a history of allergies, and individuals with asthma and/or a history of hives 
may also be affected. Symptoms include rash, hives, and itching. 
 
You must tell the Investigator or study staff about all side effects that you have. If you are not honest 
about your side effects, it may not be safe for you to stay in the study. 
 
BIRTH CONTROL, DANGERS OF PREGNANCY AND BREASTFEEDING 
 
If you are a female, you must not get pregnant while in this study. The only certain way to not get 
pregnant is to not have sex.  If you are a female and choose to have sex, you must use a type of birth 
control.   
 
Even if you use birth control during the study, there is a chance you could become pregnant.  If you are 
pregnant or become pregnant during the study, test products or procedures may involve unforeseeable 
risks to the unborn baby. 
 
A pregnancy test can be wrong.  If you become pregnant during the study, stop using the test products and 
call/inform the Investigator at once. 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
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You cannot be in the study if you are breastfeeding.  It is not known whether the test products are safe for 
breast fed babies.  Therefore if you are breastfeeding a child then it may not be safe for you to participate 
in the study.   
 
POSSIBLE BENEFITS OF THE STUDY 
 
You will not get any medical benefit from being in this study, and there is no promise that your condition 
(acne) will get better.  It might stay the same or it might get worse.  Your participation will provide 
information that may help others. There may be other marketed products that claim to have similar 
benefits. 
 
OTHER OPTIONS TO PARTICIPATING IN THE STUDY   
 
Since this study is for research only, the only other choice would be not to be in the study. 
 
STUDY AND TEST PRODUCT CONFIDENTIALITY 
 
To participate in this study, you must agree to keep any information relating to the design, identity or use 
of these test product samples confidential.  
 
On rare occasions, the sponsor may allow the testing company to disclose to you the name of the test 
products if you are not given this information during the study. This information is typically not provided 
until the end of the study or after the test products have been released for sale to the public. The study 
doctor or study staff will notify you if the sponsor allows us to give you this information. 
 
DISCLOSURE AGREEMENT 
 
This section explains how personal health information collected about you for the study may be used.  
Your personal health information includes, but is not limited to, information that was collected for your 
entry into the study and information that is collected during the study.  The purpose of collecting this 
information is to allow the study staff and the Investigator to conduct the study, to evaluate the sponsor’s 
study products and to analyze the study results.   
 
You may decide not to give permission for the release of your personal health information for the study.  
In that case, you will not be able to participate in the study.   This is because the study staff and/or the 
Investigator would not be able to collect the information needed to evaluate the sponsor’s study products. 
 
People who may inspect your personal and health information includes the Investigator, the Institutional 
Review Board, IntegReview IRB, FDA and other regulatory authorities from the United States or other 
countries, the study sponsor and people that work with the sponsor which includes, monitoring 
committees, contract research organizations, and consultants who have contracts with the company to do 
the study and review the study results. These reviews are done to check on the quality of the study and 
also for other purposes allowed by law. 
 
The results of the study may be published in a medical book or journal, or presented at meetings for 
educational purposes.  Neither your name, nor any other personal health information that specifically 
identifies you, will be used in those materials or presentations.    
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
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You may ask the Investigator to see and copy your personal health information related to the study.  You 
may also ask the Investigator to correct any study related information about you that is wrong.  You may 
have to wait until the end of the study to see your study records, so that the study can be organized 
properly.   
 
This permission to share your personal health information for this study does not have an expiration date.  
If you no longer want to share your personal health information, you may cancel your permission at any 
time by writing to the study staff and/or the Investigator at the address below: 
 
Barry T. Reece 
3207 Esters Road 
Irving, Texas 75062 
 
If you cancel your permission after you have started in the study, the study staff and the Investigator will 
stop collecting your personal health information.  Although they will stop collecting new information 
about you, they will need to use the information they have already collected to evaluate the study results.  
If you start the study and then cancel your permission, you will not be able to continue to participate in 
the study.  This is because the study staff and/or the Investigator would not be able to collect the 
information needed to evaluate the study.  
 
RCTS, Inc., and the sponsor will make every effort to keep your personal health information private.  But 
after the study staff or the Investigator share your personal health information from the study, federal 
privacy laws may not keep it private.  There might be laws in your state or other federal laws that would 
protect the privacy of this information. 
 
CONFIDENTIALITY  
 
Your records of being in this study will be kept private except when ordered by law.    The following 
people will have access to your study records: 
 
• 
The Investigator 
• 
Sponsor company or research institution [including monitor(s) and auditor(s)] 
• 
Other country, state or federal regulatory agencies 
• 
IntegReview IRB 
 
The Institutional Review Board (IRB), IntegReview, and accrediting agencies may inspect and copy your 
records, which may have your name on them.  Therefore, total confidentiality cannot be guaranteed.  If 
the study results are presented at meetings or printed in publications, your name will not be used. 
  
IN CASE OF STUDY RELATED INJURY 
 
Side effects or complications, both foreseeable and unforeseeable, are possible in any research study 
without any fault to you, the Investigator, the study site, or the study sponsor. If you get hurt or sick as a 
direct result of being in this study, the sponsor will pay the costs of reasonable medical treatment.  To ask 
questions about this, talk to the Investigator or study staff.   
 
The sponsor’s policy does not offer compensation for other expenses.  Be aware that your health care 
payer/insurer might not cover the costs of study-related injuries or illnesses. 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
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Unreimbursed medical expenses not covered by insurance or other third party coverage will be 
reimbursed by the sponsor for medical treatment for any injury that, in the opinion of the study doctor and 
the sponsor, is directly caused by the investigational product or by procedures required by the study 
protocol which would not have been performed as part of your regular medical care. 
 
LEGAL RIGHTS 
 
You will not lose any of your legal rights by signing this consent form. 
 
CONTACT INFORMATION 
 
If you have questions, concerns, or complaints about this study or to report a study related injury, contact: 
 
Barry T. Reece 
972-871-7578 daytime telephone number  
972-841-2916 after hours number (cell phone) 
 
If you are unable to reach anyone at the number(s) listed above and you need medical attention, 
please go to the nearest emergency room. 
 
If you do not want to talk to the Investigator or study staff, if you have concerns or complaints about the 
research, or to ask questions about your rights as a study subject you may contact IntegReview.  
IntegReview’s policy indicates that all concerns/complaints are to be submitted in writing for review at a 
convened IRB meeting to: 
 
Mailing Address:            OR            Email Address: 
Chairperson 
IntegReview IRB 
3815 S. Capital of Texas Highway 
Suite 320 
Austin, TX  78704 
integreview@integreview.com 
 
If you are unable to provide your concerns/complaints in writing or if this is an emergency situation 
regarding subject safety, contact our office at: 
 
512-326-3001 or 
toll free at 1-877-562-1589 
between 8 a.m. and 5 p.m. Central Time 
 
IntegReview has approved the information in this consent form and has given approval for the 
Investigator to do the study. This does not mean IntegReview has approved your being in the study.  You 
must consider the information in this consent form for yourself and decide if you want to be in this study. 
 
 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
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SEPTEMBER 16, 2016 
 
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PAYMENT FOR BEING IN THE STUDY 
 
You may receive up to $600.00 for being in the study. You will be paid per completed visit as follows: 
   
Visit 
Compensation (amount) 
Visit 1: Screening 
$25.00 
Visit 2: Baseline 
$50.00 
Visit 3: Week 1 
$50.00 
Visit 4: Week 2 
$50.00 
Visit 5: Week 6 
$50.00 
Visit 6: Week 12 
$50.00 
Visit 7: Week 18 
$50.00 
Visit 8: Week 24 
$50.00 
Bonus for completing all visits: 
$225.00 
 
If you choose to leave or are withdrawn from the study for any reason before finishing all visits you will 
be paid for each completed visit.  You will receive payment on the originally scheduled last day of the 
study. 
 
If you are paid $600.00 or more by RCTS, Inc., in a calendar year, those payments will be reported to the 
Internal Revenue Service via form 1099-MISC. As required by tax laws, if you withhold your social 
security number, RCTS, Inc. is required to withhold 28% of your payment for tax purposes. In this case a 
form 1099-MISC will be sent to you reporting your withholding. 
 
VOLUNTEERING TO BE IN THE STUDY 
 
It is your choice if you want to be in the study.  No one can force you to be in the study.  You may not 
want to be in this study or you may leave the study at any time without penalty or loss of benefits to 
which you are otherwise entitled.   
 
The Investigator, the sponsor company, or IntegReview may take you out of the study without your 
permission, at any time, for the following reasons: 
 
 
• 
If you do not follow the Investigator’s instructions  
• 
If we find out you should not be in the study 
• 
If the study is stopped 
• 
If it becomes harmful to your health 
 
If you leave the study or if you are taken out of the study, you may be asked to return for a final visit to 
have some end of study evaluations or tests.  If information generated from this study is published or 
presented, your identity will not be revealed.  If you leave the study, no more information about you will 
be collected for this study.  However, all of the information you gave us before you left the study will still 
be used.  
 
NEW FINDINGS 
 
If there is new information or any significant new findings that could relate to your willingness to 
continue participation we will tell you.  You can then decide if you still want to be in the study.   


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
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APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
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THE REASON FOR INSTITUTIONAL REVIEW BOARDS AND INFORMED CONSENT 
 
What is a consent form? 
The informed consent document contains information required by federal regulations.  The informed 
consent document must be approved by an Institutional Review Board (IRB). 
 
What is an Institutional Review Board (IRB)? 
An Institutional Review Board (IRB) is a group of people that reviews research studies.  The main goal of 
this review is to protect the rights and well being of the human subjects participating in research studies. 
IntegReview, the IRB for this study 
IntegReview is an IRB whose board members provide IRB services across the United States, Canada, 
Japan and Latin America. 
 
To meet requirements of the law, the IntegReview Boards currently include:  
 
• 
Doctors  
• 
Pharmacists  
• 
Nurses  
• 
Toxicologists (people who study the harmful effects of chemicals)  
• 
Other specialists 
• 
Others who do not have a background in science/medicine 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
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Informed Consent 
 
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AGREEMENT TO BE IN THE STUDY 
 
This consent form contains important information to help you decide if you want to be in the study.  If 
you have any questions that are not answered in this consent form, ask one of the study staff.  
 
Please answer YES or NO to the following questions: 
 
A. 
Is this document in a language you understand?  
 
 
 
 
 
 
 
B. 
Do you understand the information in this consent form?  
 
 
 
 
 
 
C. 
Have you been given enough time to ask questions and talk about the study? 
 
 
 
 
D. 
Have all of your questions been answered to your satisfaction? 
 
 
 
 
 
 
E. 
Do you think you received enough information about the study?  
 
 
 
 
 
F. 
Do you volunteer to be in this study of your own free will and without being  
pressured by the Investigator or study staff? 
 
 
 
 
 
 
 
 
G. 
Do you know that you can leave the study at any time without giving 
a reason and without affecting your health care?  
 
 
 
 
 
 
 
H. 
Do you know that your health records from this study may be reviewed 
by the sponsor company and by government authorities?  
 
 
 
 
 
 
I. 
Do you know that you cannot be in another study while you are in this study? 
 
 
 
 
IF YOU ANSWERED “NO” TO ANY OF THE ABOVE QUESTIONS, 
OR YOU ARE UNABLE TO ANSWER ANY OF THE ABOVE QUESTIONS, 
YOU SHOULD NOT SIGN THIS CONSENT FORM. 
 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
  
 
 
 
 
 
 
 
 
 
 
Printed Name of Person Explaining Consent Form 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Person Explaining Consent Form 
 
 
 
 
 
Date 
 
 
 
You will be given a signed and dated copy of this consent form to keep. 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
Page 12 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE 
VERSION CONTROL 
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Authorization and Photographic Release Form 
 
I hereby for good and valuable consideration grant to RCTS, Inc.,  the study sponsor and their respective 
affiliates, agencies, agents, employees, and assigns (collectively, “Authorized Entities”), the unrestricted, 
royalty free, irrevocable and perpetual right and permission to reproduce, distribute, broadcast and/or 
otherwise use for advertising and other commercial/noncommercial purposes:  (i) my name, likeness, 
image, video, and any other biographical or personal information (“Personal Content”); and (ii) any 
statement or endorsement, or any portions thereof (“Testimonial(s)”), made by me relating to the study 
sponsor’s products (“Products”), in any and all media now known or later developed, worldwide in 
perpetuity, without further compensation or approval by me. 
 
I hereby assign to the Authorized Entities all of my world-wide right, title and interest, including my 
copyright interests and all renewals, reissues and extensions thereof, in and to the Personal Content and 
Testimonial(s), including without limitation, any photographic portraits, sound recordings and video 
performances of and/or by me in connection with the Personal Content and/or Testimonial(s).    
  
I am at least 21 years of age, and competent to contract in my own name.  I have read and understand this 
Authorization and Release. 
 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Person Explaining Release Form 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Person Explaining Release Form 
 
 
 
 
 
Date  
 
 
 
Copy of consent form given to subject on ______________ (date) by ______________ (initials) 
 
You will be given a signed and dated copy of this consent form to keep. 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
Page 13 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE 
VERSION CONTROL 
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AUTHORIZATION TO USE AND DISCLOSE PERSONAL HEALTH INFORMATION FOR 
RESEARCH 
  
THIS SECTION DESCRIBES YOUR RIGHTS AND HOW PERSONAL HEALTH INFORMATION 
COLLECTED ABOUT YOU DURING THIS STUDY MAY BE USED AND DISCLOSED AND HOW 
YOU CAN GET ACCESS TO THIS INFORMATION.  PLEASE REVIEW IT CAREFULLY. 
  
The United States government has issued a privacy rule to protect the privacy rights of patients.  This rule 
was issued under a law called the Health Insurance Portability and Accountability Act of 1996 
(HIPAA).  The Privacy Rule is designed to protect the confidentiality of your personal health 
information.  The document you are reading, called an “Authorization,” describes your rights and 
explains how your health information will be used and disclosed (shared). 
  
Federal law requires hospitals, researchers and health care providers to protect the privacy of information 
that identifies you and relates to your past, present and future physical and mental health or conditions. 
  
All information collected during the study will be retained by the study doctor and the Study Sponsor, 
except as required by law.  Information from this study will be given to the sponsor.  “Sponsor” includes 
any persons or companies, which are contracted by the sponsor to have access to the research information 
during and after the study.  The information will also be given to the U.S. Food and Drug Administration 
(FDA).  Study records which identify you and the consent form signed by you will be inspected and/or 
copied for research or regulatory purposes by: 
  
• 
Sponsor  
• 
Agents for the sponsor 
• 
The US Food and Drug Administration (FDA) 
• 
Department of Health and Human Services (DHHS) agencies 
• 
IntegReview IRB  
  
Because of the need to release information to these parties, absolute confidentiality cannot be 
guaranteed.  The results of this research study may be presented at meetings or in publications; however, 
your identity will not be disclosed in those presentations. 
  
For purposes of study reporting, you will be identified by your initials and code numbers only.  However, 
your name, date of birth, address, and phone number will be kept on record by the study doctor in case 
you need to be contacted in the future about this study. 
  
After your personal health information is disclosed to the Study Sponsor, the results of the study may be 
reanalyzed at a later date and may be combined with the results of other studies.   The Study Sponsor and 
people who work with the Study Sponsor may use the results of this study for other research purposes, 
including:  
  
• 
Developing a better understanding of the disease; 
• 
Improving the design of future actual use trials 
  
After the study staff or the study doctor discloses your personal health information to others, it could be 
re-disclosed and no longer protected by federal privacy laws. 
  


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
Page 14 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE 
VERSION CONTROL 
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This permission to share your personal health information for this study does not have an expiration 
date.  If you do not withdraw this Authorization in writing, it will remain in effect indefinitely. Your 
study doctor will keep this Authorization for at least 6 years.  If you no longer want to share your personal 
health information, you may cancel your permission at any time by writing to the study staff and/or the 
study doctor at the address below: 
 
RCTS, Inc., 
3207 Esters Road 
Irving, Texas, 75062 
 
You have the right to see and get a copy of your records related to the study for as long as the study 
doctor has this information.  However, by signing this Authorization you agree that you might not be able 
to review or receive some of your records related to the study until after the study has been completed. 
  
If you cancel your permission after you have started in the study, the study staff and the study doctor will 
stop collecting your personal health information unless the information concerns an adverse event (a bad 
effect) related to the study.  If an adverse event occurs, your entire medical record may be reviewed.  All 
information that has already been collected for study purposes, and any new information about an adverse 
event related to the study, will be sent to the study sponsor.  Although they will stop collecting new 
information about you, they will need to use the information they have already collected to evaluate the 
study results.  If you start the study and then cancel your permission, you will not be able to continue to 
participate in the study.  This is because the study staff and/or the study doctor would not be able to 
collect the information needed to evaluate the study results. 
  
If you withdraw from the study but do not withdraw your Authorization, new personal health information 
may be collected until this study ends.  
  
You may decide not to give permission for the release of your personal health information for this 
study.  In that case, you will not be able to participate.  This is because the study staff and study doctor 
would not be able to collect the information needed to evaluate the study results. 
  
At the completion of the study, you have the right to access your protected health information that is 
created during this research study that relates to your treatment or to payment, provided such information 
is not exempted under certain laws and regulations.  To request this information, please contact the study 
doctor at the address listed above. 
  
Your Right to Access Health Information 
 
Subject to certain exceptions prescribed by law, you have a right to request access to the health 
information that we hold about you and to request changes if your health information is incorrect or 
incomplete. Any request for access or corrections should be made to the principal doctor conducting this 
study. 
 
Your records obtained while you are in this trial, as well as related health records, will remain strictly 
confidential at all times.  However, these will need to be made available to others working on the 
Sponsor’s behalf, the Independent Ethics Committee members and Medicines Regulatory Authorities. 
 


Protocol number C16-CD020 (GLI.04.SPR.US10354) 
Barry T. Reece 
Informed Consent 
 
Page 15 of 15 
APPROVED BY 
INTEGREVIEW IRB 
SEPTEMBER 16, 2016 
 
THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE 
VERSION CONTROL 
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By signing the consent form you agree to this access for the current trial and any further research that may 
be done.  However, the Sponsor will take steps to protect your personal information and will not include 
your name on any sponsor forms, reports, publications, or in any future disclosures.  If you withdraw 
from the study, we will no longer collect your personal information, but we may need to continue to use 
information already collected. 
 
Personal data which may be sensitive (e.g., date of birth) will be collected and processed, but only for 
research purposes in connection with this trial. 
 
The trial data will be sent around the world, but you will not be referred to by name or identified in any 
report or publication nor could the data be traced back to you.  Your data may be transferred to a country 
that does not have the same level of personal data protection as within the United States.  However, 
The Sponsor maintains high standards of confidentiality and protection. 
 
The Sponsor (who will control the use of the data) will take steps to ensure your personal data is 
protected. 
 
By taking part in this trial you agree not to restrict the use of any data even if you withdraw from the trial 
and agree to the transfer of your personal data to other Sponsor companies and to Medicines Regulatory 
Authorities both within and outside of Europe. 
 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Adult Study Subject 
 
 
 
 
 
 
 
 
 
 
Signature of Adult Study Subject 
 
 
 
 
 
 
Date 
 
  
 


 
 
 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 1 –Baseline (Day 1)   
INCLUSION CRITERIA 
 
Yes 
No* 
1. Is a man or woman between the ages of 21 and 45 years of age at the 
time of enrollment. 
 
 
2. Has mild to moderate acne (score of 2-3 on FDA Investigator’s Global 
Assessment Scale) on the face. 
 
 
3. Have at least 5 inflammatory lesions. 
 
 
4. Have 10 – 100 non-inflammatory lesions. 
 
 
5. Is willing to use the test products as instructed for 24 weeks. 
 
 
6. Has a Fitzpatrick skin type I-VI  
 
 
7. Is willing and able to comply with all of the time commitments and 
procedural requirements of the clinical trial protocol. 
 
 
8. Is willing to provide written informed consent including photo release, 
Health Insurance Portability and Accountability Act (HIPAA), and is able to 
read, speak, write, understand English and is willing to share personal 
information and data, as verified by signing a written authorization at the 
screening 
 
 
9. Is willing to withhold all facial treatments during the course of the study 
including botulinum toxin, injectable fillers, microdermabrasion, IPL, 
peels, facials, laser treatments and tightening treatments.  Waxing and 
threading is allowed but not facial laser hair removal. 
 
 
10. If male, who is a regular shaver and willing to shave on the day of the 
study visits (prior to clinic visits). 
 
 
11. If a woman of child bearing potential, is willing to take a urine pregnancy 
test prior to study enrollment, at week 24, and when deemed appropriate 
by the Investigator and/or Sponsor. 
 
 
12. Is of child bearing potential who uses an acceptable method of 
contraception throughout the study.  Acceptable methods of birth control 
include 
• 
Oral and other system contraceptives. Individuals must be on a 
stable use for 3 months prior to study enrollment. Individuals on 
oral contraceptives must not alter their use, including dose or 
regimen for the duration of the study 
• 
Double barrier 
• 
Bilateral tubal ligation 
• 
Partner vasectomy 
• 
Abstinence 
 
 
13. Is willing to follow study requirements and report any changes in health 
status or medications, adverse event symptoms, or reactions immediately. 
 
 
14. Must be stable on any medication they are taking for at least 30 days 
 
 
*If any criterion is answered no*, DO NOT enroll the subject. 
Visit 1 –Baseline (Day 1) 
EXCLUSION CRITERIA  
APPROVED 
FEBRUARY 20, 2016 
INTEGREVIEW


 
 
 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
 
Yes* 
No 
1. Has been diagnosed with allergies to topical acne products. 
 
 
2. Has a condition and/or disease of the skin that the Investigator deems 
inappropriate for participation. 
 
 
3. Is nursing, pregnant, or planning to become pregnant during the study. 
 
 
4. Have pre-existing or dormant dermatologic conditions on the face (e.g., 
psoriasis, rosacea, eczema, seborrheic dermatitis, severe excoriations etc.) 
which in the opinion of the Investigator could interfere with the outcome of the 
study. 
 
 
5. Has a history of immunosuppression/immune deficiency disorders (including 
(HIV infection or AIDS) or currently using immunosuppressive medications (e.g., 
azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, 
mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.). 
 
 
6. Has an uncontrolled disease such as asthma, diabetes, hypertension, 
hyperthyroidism, or hypothyroidism. Individuals having multiple health 
conditions may be excluded from participation even if the conditions are 
controlled by diet, medication, etc. at the Investigator’s discretion. 
 
 
7. Is currently participating in another facial usage study or has participated in a 
clinical trial at Stephens or at another research facility or doctor’s office within 
4 weeks prior to inclusion into the study. 
 
 
8. Has a history of skin cancer within the past 5 years. 
 
 
9. Has any planned surgeries and/or invasive medical procedures during the 
course of the study. 
 
 
10. Has started hormone replacement therapies (HRT) or hormones for birth 
control less than 3 months prior to study entry or plans on starting, stopping, or 
changing doses of HRT or hormones for birth control during the study. 
 
 
11. Has facial sunburn or excessive tanned facial skin or is not willing to avoid daily 
sun exposure on the face and the use of tanning beds or sunless tanning 
products for the duration of the study. 
 
 
12. Has severe acne, acne conglobata, multiple nodules or cysts (more than 2). 
 
 
13. Is currently taking a natural or prescription testosterone blocker (e.g. saw 
palmetto, blask cohosh, chaste tree, chasteberry, spironolactone, drospirenone, 
progestins). 
 
 
14. Is currently on a testosterone booster or prescription testosterone (e.g. DHEA, 
tribulus, testosterone cypionate, testosterone enanthate, Sustanon, 
testosterone propionate, testosterone phenylpropriate, Omnadren etc.). 
 
 
 (CONTINUED ON NEXT PAGE) 
 
 
 
 
 
APPROVED 
FEBRUARY 20, 2016 
INTEGREVIEW


 
 
 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 1 –Baseline  
EXCLUSION CRITERIA (CONTINUED) 
 
Yes* 
No 
15. Is currently taking or has taken within the last 30 days oral or topical 
prescription medications for acne such as Doxycycline, Minocycline, 
Clindamycin, Bactrim, Tetracycline, Erythromycin, Vibramycin and topical 
tretinoin.(Retin A Renova, Adapalene, Tazarotene), Azelaic acid, benzoyl 
peroxide, Dapsone, Sodium sulfacetamide, Differin, Epiduo. 
 
 
16. Has used oral isotretinoin (Accutane) within the past 6-months. 
 
 
17. Is routinely using (3x a week or more) topical OTC acne product (e.g. benzoyl 
peroxide, salicylic acid, alpha hydroxyl, beta hydroxyl and/or poly-hydroxy 
products or medicated cleansers, wipes, masks, scrubs, gels and creams) within 
30 days of the study entry. 
 
 
18. Is using or has used any systemic medication considered to affect the course of 
acne, specifically, but not exclusively antibiotics or steroids within the last 30 
days prior to entry into the study. 
 
 
19. Has excessive facial hair, including beard, mustache or goatee, or scars, which 
could interfere with evaluations by Investigator or designee. 
 
 
*If any criterion is answered Yes*, DO NOT enroll the subject. 
 
Visit 1 – Baseline  
INCLUSION/EXCLUSION  
Is the subject eligible per Inclusion/Exclusion criteria? 
 
 Yes       
 
 No   If no, please indicate which Inclusion/Exclusion criteria the subject did not meet and complete 
End of Study page: 
 
                Inclusion #_____________     Exclusion #________________ 
 
 
 
Investigators review 
I affirm that all required information has been reviewed by me, deemed accurate and complete and 
that the subject meets the inclusion/exclusion criteria, and is eligible to be enrolled in the study.  
 
_____________________________________________     ______-________-____________ 
Investigator’s Signature                                                                  DD         MMM            YYYY 
 
APPROVED 
FEBRUARY 20, 2016 
INTEGREVIEW


 
 
 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 1 –Baseline (Day 1)   
INCLUSION CRITERIA 
 
Yes 
No* 
1. Is a man or woman between the ages of 21 and 45 years of age at the 
time of enrollment. 
 
 
2. Has mild to moderate acne (score of 2-3 on FDA Investigator’s Global 
Assessment Scale) on the face. 
 
 
3. Have at least 5 inflammatory lesions. 
 
 
4. Have 10 – 100 non-inflammatory lesions. 
 
 
5. Is willing to use the test products as instructed for 24 weeks. 
 
 
6. Has a Fitzpatrick skin type I-VI  
 
 
7. Is willing and able to comply with all of the time commitments and 
procedural requirements of the clinical trial protocol. 
 
 
8. Is willing to provide written informed consent including photo release, 
Health Insurance Portability and Accountability Act (HIPAA), and is able to 
read, speak, write, understand English and is willing to share personal 
information and data, as verified by signing a written authorization at the 
screening 
 
 
9. Is willing to withhold all facial treatments during the course of the study 
including botulinum toxin, injectable fillers, microdermabrasion, IPL, 
peels, facials, laser treatments and tightening treatments.  Waxing and 
threading is allowed but not facial laser hair removal. 
 
 
10. If male, who is a regular shaver and willing to shave on the day of the 
study visits (prior to clinic visits). 
 
 
11. If a woman of child bearing potential, is willing to take a urine pregnancy 
test prior to study enrollment, at week 24, and when deemed appropriate 
by the Investigator and/or Sponsor. 
 
 
12. Is of child bearing potential who uses an acceptable method of 
contraception throughout the study.  Acceptable methods of birth control 
include 
• 
Oral and other system contraceptives. Individuals must be on a 
stable use for 3 months prior to study enrollment. Individuals on 
oral contraceptives must not alter their use, including dose or 
regimen for the duration of the study 
• 
Double barrier 
• 
Bilateral tubal ligation 
• 
Partner vasectomy 
• 
Abstinence 
 
 
13. Is willing to follow study requirements and report any changes in health 
status or medications, adverse event symptoms, or reactions immediately. 
 
 
14. Must be stable on any medication they are taking for at least 30 days 
 
 
*If any criterion is answered no*, DO NOT enroll the subject. 
Visit 1 –Baseline (Day 1) 
EXCLUSION CRITERIA  
APPROVED 
FEBRUARY 29, 2016 
INTEGREVIEW


 
 
 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
 
Yes* 
No 
1. Has been diagnosed with allergies to topical acne products. 
 
 
2. Has a condition and/or disease of the skin that the Investigator deems 
inappropriate for participation. 
 
 
3. Is nursing, pregnant, or planning to become pregnant during the study. 
 
 
4. Have pre-existing or dormant dermatologic conditions on the face (e.g., 
psoriasis, rosacea, eczema, seborrheic dermatitis, severe excoriations etc.) 
which in the opinion of the Investigator could interfere with the outcome of the 
study. 
 
 
5. Has a history of immunosuppression/immune deficiency disorders (including 
(HIV infection or AIDS) or currently using immunosuppressive medications (e.g., 
azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, 
mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.). 
 
 
6. Has an uncontrolled disease such as asthma, diabetes, hypertension, 
hyperthyroidism, or hypothyroidism. Individuals having multiple health 
conditions may be excluded from participation even if the conditions are 
controlled by diet, medication, etc. at the Investigator’s discretion. 
 
 
7. Is currently participating in another facial usage study or has participated in a 
clinical trial at Stephens or at another research facility or doctor’s office within 
4 weeks prior to inclusion into the study. 
 
 
8. Has a history of skin cancer within the past 5 years. 
 
 
9. Has any planned surgeries and/or invasive medical procedures during the 
course of the study. 
 
 
10. Has started hormone replacement therapies (HRT) or hormones for birth 
control less than 3 months prior to study entry or plans on starting, stopping, or 
changing doses of HRT or hormones for birth control during the study. 
 
 
11. Has facial sunburn or excessive tanned facial skin or is not willing to avoid daily 
sun exposure on the face and the use of tanning beds or sunless tanning 
products for the duration of the study. 
 
 
12. Has severe acne, acne conglobata, multiple nodules or cysts (more than 2). 
 
 
13. Is currently taking a natural or prescription testosterone blocker (e.g. saw 
palmetto, blask cohosh, chaste tree, chasteberry, spironolactone, drospirenone, 
progestins). 
 
 
14. Is currently on a testosterone booster or prescription testosterone (e.g. DHEA, 
tribulus, testosterone cypionate, testosterone enanthate, Sustanon, 
testosterone propionate, testosterone phenylpropriate, Omnadren etc.). 
 
 
 (CONTINUED ON NEXT PAGE) 
 
 
 
 
 
APPROVED 
FEBRUARY 29, 2016 
INTEGREVIEW


 
 
 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 1 –Baseline  
EXCLUSION CRITERIA (CONTINUED) 
 
Yes* 
No 
15. Is currently taking or has taken within the last 30 days oral or topical 
prescription medications for acne such as Doxycycline, Minocycline, 
Clindamycin, Bactrim, Tetracycline, Erythromycin, Vibramycin and topical 
tretinoin.(Retin A Renova, Adapalene, Tazarotene), Azelaic acid, benzoyl 
peroxide, Dapsone, Sodium sulfacetamide, Differin, Epiduo. 
 
 
16. Has used oral isotretinoin (Accutane) within the past 6-months. 
 
 
17. Is routinely using (3x a week or more) topical OTC acne product (e.g. benzoyl 
peroxide, salicylic acid, alpha hydroxyl, beta hydroxyl and/or poly-hydroxy 
products or medicated cleansers, wipes, masks, scrubs, gels and creams) within 
30 days of the study entry. 
 
 
18. Is using or has used any systemic medication considered to affect the course of 
acne, specifically, but not exclusively antibiotics or steroids within the last 30 
days prior to entry into the study. 
 
 
19. Has excessive facial hair, including beard, mustache or goatee, or scars, which 
could interfere with evaluations by Investigator or designee. 
 
 
*If any criterion is answered Yes*, DO NOT enroll the subject. 
 
Visit 1 – Baseline  
INCLUSION/EXCLUSION  
Is the subject eligible per Inclusion/Exclusion criteria? 
 
 Yes       
 
 No   If no, please indicate which Inclusion/Exclusion criteria the subject did not meet and complete 
End of Study page: 
 
                Inclusion #_____________     Exclusion #________________ 
 
 
 
Investigators review 
I affirm that all required information has been reviewed by me, deemed accurate and complete and 
that the subject meets the inclusion/exclusion criteria, and is eligible to be enrolled in the study.  
 
_____________________________________________     ______-________-____________ 
Investigator’s Signature                                                                  DD         MMM            YYYY 
 
APPROVED 
FEBRUARY 29, 2016 
INTEGREVIEW


 
 
 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
Barry T. Reece 
(RCTS, Inc.) 
Subject Initials  
 
 
 
 
Screening Number 
 
 
 
 
Visit 1 –Screening/Baseline (Day 1)   
INCLUSION CRITERIA 
 
Yes 
No* 
1. Is a man or woman between the ages of 21 and 45 years of age at the 
time of enrollment. 
 
 
2. Has mild to moderate acne (score of 2-3 on FDA Investigator’s Global 
Assessment Scale) on the face. 
 
 
3. Have at least 5 inflammatory lesions. 
 
 
4. Have 10 – 100 non-inflammatory lesions. 
 
 
5. Is willing to use the test products as instructed for 24 weeks. 
 
 
6. Has a Fitzpatrick skin type I-VI  
 
 
7. Is willing and able to comply with all of the time commitments and 
procedural requirements of the clinical trial protocol. 
 
 
8. Is willing to provide written informed consent including photo release, 
Health Insurance Portability and Accountability Act (HIPAA), and is able to 
read, speak, write, understand English and is willing to share personal 
information and data, as verified by signing a written authorization at the 
screening 
 
 
9. Is willing to withhold all facial treatments during the course of the study 
including botulinum toxin, injectable fillers, microdermabrasion, IPL, 
peels, facials, laser treatments and tightening treatments.  Waxing and 
threading is allowed but not facial laser hair removal. 
 
 
10. If male, who is a regular shaver and willing to shave on the day of the 
study visits (prior to clinic visits). 
 
 
11. If a woman of child bearing potential, is willing to take a urine pregnancy 
test prior to study enrollment, at week 24, and when deemed appropriate 
by the Investigator and/or Sponsor. 
 
 
12. Is of child bearing potential who uses an acceptable method of 
contraception throughout the study.  Acceptable methods of birth control 
include 
• 
Oral and other system contraceptives. Individuals must be on a 
stable use for 3 months prior to study enrollment. Individuals on 
oral contraceptives must not alter their use, including dose or 
regimen for the duration of the study 
• 
Double barrier 
• 
Bilateral tubal ligation 
• 
Partner vasectomy 
• 
Abstinence 
 
 
13. Is willing to follow study requirements and report any changes in health 
status or medications, adverse event symptoms, or reactions immediately. 
 
 
14. Must be stable on any medication they are taking for at least 30 days 
 
 
*If any criterion is answered no*, DO NOT enroll the subject. 
 
 
APPROVED 
FEBRUARY 25, 2016 
INTEGREVIEW


 
 
 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
Barry T. Reece 
(RCTS, Inc.) 
Subject Initials  
 
 
 
 
Screening Number 
 
 
 
 
Visit 1 –Screening/Baseline (Day 1) 
EXCLUSION CRITERIA  
 
Yes* 
No 
1. Has been diagnosed with allergies to topical acne products. 
 
 
2. Has a condition and/or disease of the skin that the Investigator deems 
inappropriate for participation. 
 
 
3. Is nursing, pregnant, or planning to become pregnant during the study. 
 
 
4. Have pre-existing or dormant dermatologic conditions on the face (e.g., 
psoriasis, rosacea, eczema, seborrheic dermatitis, severe excoriations etc.) 
which in the opinion of the Investigator could interfere with the outcome of the 
study. 
 
 
5. Has a history of immunosuppression/immune deficiency disorders (including 
(HIV infection or AIDS) or currently using immunosuppressive medications (e.g., 
azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, 
mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.). 
 
 
6. Has an uncontrolled disease such as asthma, diabetes, hypertension, 
hyperthyroidism, or hypothyroidism. Individuals having multiple health 
conditions may be excluded from participation even if the conditions are 
controlled by diet, medication, etc. at the Investigator’s discretion. 
 
 
7. Is currently participating in another facial usage study or has participated in a 
clinical trial at this or at another research facility or doctor’s office within 4 
weeks prior to inclusion into the study. 
 
 
8. Has a history of skin cancer within the past 5 years. 
 
 
9. Has any planned surgeries and/or invasive medical procedures during the 
course of the study. 
 
 
10. Has started hormone replacement therapies (HRT) or hormones for birth 
control less than 3 months prior to study entry or plans on starting, stopping, or 
changing doses of HRT or hormones for birth control during the study. 
 
 
11. Has facial sunburn or excessive tanned facial skin or is not willing to avoid daily 
sun exposure on the face and the use of tanning beds or sunless tanning 
products for the duration of the study. 
 
 
12. Has severe acne, acne conglobata, multiple nodules or cysts (more than 2). 
 
 
13. Is currently taking a natural or prescription testosterone blocker (e.g. saw 
palmetto, blask cohosh, chaste tree, chasteberry, spironolactone, drospirenone, 
progestins). 
 
 
14. Is currently on a testosterone booster or prescription testosterone (e.g. DHEA, 
tribulus, testosterone cypionate, testosterone enanthate, Sustanon, 
testosterone propionate, testosterone phenylpropriate, Omnadren etc.). 
 
 
 (CONTINUED ON NEXT PAGE) 
 
 
 
 
 
APPROVED 
FEBRUARY 25, 2016 
INTEGREVIEW


 
 
 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
Barry T. Reece 
(RCTS, Inc.) 
Subject Initials  
 
 
 
 
Screening Number 
 
 
 
 
Visit 1 –Screening/Baseline  
EXCLUSION CRITERIA (CONTINUED) 
 
Yes* 
No 
15. Is currently taking or has taken within the last 30 days oral or topical 
prescription medications for acne such as Doxycycline, Minocycline, 
Clindamycin, Bactrim, Tetracycline, Erythromycin, Vibramycin and topical 
tretinoin.(Retin A Renova, Adapalene, Tazarotene), Azelaic acid, benzoyl 
peroxide, Dapsone, Sodium sulfacetamide, Differin, Epiduo. 
 
 
16. Has used oral isotretinoin (Accutane) within the past 6-months. 
 
 
17. Is routinely using (3x a week or more) topical OTC acne product (e.g. benzoyl 
peroxide, salicylic acid, alpha hydroxyl, beta hydroxyl and/or poly-hydroxy 
products or medicated cleansers, wipes, masks, scrubs, gels and creams) within 
30 days of the study entry. 
 
 
18. Is using or has used any systemic medication considered to affect the course of 
acne, specifically, but not exclusively antibiotics or steroids within the last 30 
days prior to entry into the study. 
 
 
19. Has excessive facial hair, including beard, mustache or goatee, or scars, which 
could interfere with evaluations by Investigator or designee. 
 
 
*If any criterion is answered Yes*, DO NOT enroll the subject. 
 
Visit 1 – Screening/Baseline  
INCLUSION/EXCLUSION  
Is the subject eligible per Inclusion/Exclusion criteria? 
 
 Yes       
 
 No   If no, please indicate which Inclusion/Exclusion criteria the subject did not meet and complete 
End of Study page: 
 
                Inclusion #_____________     Exclusion #________________ 
 
 
 
Investigators review 
I affirm that all required information has been reviewed by me, deemed accurate and complete and 
that the subject meets the inclusion/exclusion criteria, and is eligible to be enrolled in the study.  
 
_____________________________________________     ______-________-____________ 
Investigator’s Signature                                                                  DD         MMM            YYYY 
 
APPROVED 
FEBRUARY 25, 2016 
INTEGREVIEW


Page 1 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
 
Visit 1 –Screening   
                   
 
 
Visit Date:  _____-_____-_____ 
                                                                                                                               DD-MMM-YYYY 
Check In Procedures 
Has the subject cleansed their face and removed all makeup at least 30 minutes prior?  
 Yes                          No (If no, subject needs to remove residual makeup and acclimate 20 minutes) 
 
Acclimation 
*Reminder: Subject must acclimate for at least 15 minutes in temperature of 68-75°F and relative 
humidity range 35-65% before starting assessments, and photography procedures. 
Acclimation start time :_______:_______ AM/PM 
Acclimation end time :_______:_______ AM/PM 
 
Technician initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
Informed Consent/HIPAA/Photo Release 
Date & Time Consent 
Obtained 
  
Time: __ __ : __ __  AM / PM 
__ __ - __ __ __ - __ __ __ __ 
 DD          MMM             YYYY 
Date of HIPAA 
Authorization 
__ __ - __ __ __ - __ __ __ __ 
 DD          MMM             YYYY 
 
YES 
NO 
Was consent obtained prior to any study related procedure? 
 
 
Was the consent reviewed with the subject? 
 
 
Was the subject allowed to ask questions and have them answered? 
 
 
Did the subject receive a fully executed and signed copy of the consent?  
 
 
Was the photo release signed? 
 
 
 
Demographics 
Sex:  Male        Female 
Date of Birth: _____  /   _____  /   ______ 
                            DD         MMM          YYYY 
Must be between 21 and 45 years of age. 
Age ( Years):   ___    ___ 
Race: 
Ethnicity: 
American Indian/Alaskan Native        
Asian 
Black/African American 
 
Native Hawaiian/ other Pacific Islander         
White      
 
Other: (specify) ______________ 
  Hispanic or Latino 
  Not Hispanic or Latino 
 
Fitzpatrick Skin Type (Mark one):      I    II   III    IV   V   VI   
 


Page 2 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
All Visits   
Medical History                            Page  1  2  3  4  5  __                     Last Page 
 Check this box only if there is NO recent and relevant medical history and leave the form blank                                                          
Enter all recent/relevant past and/or concomitant medical conditions and past surgeries with an onset date prior to Screening. 
Enter only one condition or surgery per line. When entering a condition and a surgery related to that condition, use one line for 
the condition and one line for the surgery. Enter all medications taken within 6 months prior to Screening on the concomitant 
medication page. 
A year is required for Date of Diagnosis/Surgery and Resolved.  Enter UN for any unknown DD or MMM. 
Condition/Diagnosis/Surgery 
Date of Diagnosis/Surgery 
(DD-MMM-YYYY) 
Date Resolved 
(DD-MMM-YYYY) 
Ongoing 
Physician
’s initials 
and date 
 
 
_____  -    _______   -    ______ 
    DD    -    MMM       -      YYYY 
 
_____  -    _______   -    ______ 
    DD    -    MMM       -      YYYY 
 
 
 
 
 
_____  -    _______   -    ______ 
    DD    -    MMM       -      YYYY 
 
_____  -    _______   -    ______ 
    DD    -    MMM       -      YYYY 
 
 
 
 
 
_____  -    _______   -    ______ 
    DD    -    MMM       -      YYYY 
 
_____  -    _______   -    ______ 
    DD    -    MMM       -      YYYY 
 
 
 
 
 
_____  -    _______   -    ______ 
    DD    -    MMM       -      YYYY 
 
_____  -    _______   -    ______ 
    DD    -    MMM       -      YYYY 
 
 
 
 
 
_____  -    _______   -    ______ 
    DD    -    MMM       -      YYYY 
 
_____  -    _______   -    ______ 
    DD    -    MMM       -      YYYY 
 
 
 
 
 
_____  -    _______   -    ______ 
    DD    -    MMM       -      YYYY 
 
_____  -    _______   -    ______ 
    DD    -    MMM       -      YYYY 
 
 
 
 
 
_____  -    _______   -    ______ 
    DD    -    MMM       -      YYYY 
 
_____  -    _______   -    ______ 
    DD    -    MMM       -      YYYY 
 
 
 
 
 
_____  -    _______   -    ______ 
    DD    -    MMM       -      YYYY 
 
_____  -    _______   -    ______ 
    DD    -    MMM       -      YYYY 
 
 
 
Enter all medications taken within 6 months prior to Screening on the concomitant medication page. 


Page 3 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
 
 
 
All Visits   
MEDICATIONS 
RECORD ANY MEDICATIONS INCLUDING PRESCRIPTION AND OTC DRUGS TAKEN REGURARLY, INTERMITTITENTLY OR ONE TIME ONLY TAKEN WITHIN 6 MONTHS 
PRIOR TO SIGING THE ICF UNTIL THE END OF THE STUDY.  A year is required for Start Date.  Enter UN for any unknown DD or MMM. 
                                                                                                                                                                                                                       Page  1  2  3  4  5  __ 
 Review for prohibited medications  use for the last 6 months                                                                                                                                    Last Page                                  
                                                               
   NONE USED/TAKEN (leave rest of the page blank ) 
Drug name (Generic or 
Brand name) 
Indication 
Used to 
treat an AE? 
Dose 
Frequency 
Route* 
Start Date 
Stop Date 
(DD-MMM-YYYY) 
Ongoing 
Physician’s 
initials and date 
 
 
 Yes 
 No 
 
 
 
Start  
___ ___- ___ ___ ___- __ __ __  
Stop  
___ ___- ___ ___ ___- __ __ __  
 
 
 
 
 Yes 
 No 
 
 
 
Start  
___ ___- ___ ___ ___- __ __ __  
Stop  
___ ___- ___ ___ ___- __ __ __  
 
 
 
 
 Yes 
 No 
 
 
 
Start  
___ ___- ___ ___ ___- __ __ __  
Stop  
___ ___- ___ ___ ___- __ __ __  
 
 
*1=oral, 2=topical, 3=subcutaneous, 4=transdermal, 5=Intraocular,6=Intramuscular, 7=Inhalation, 8= Intralesion, 9=Intraperitoneal, 10=Intravenous, 
11=Nasal, 12=Vaginal, 13=Rectal,14= Ophthalmic, 15=Unknown, 16=Other 


Page 4 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 1 – Screening 
Qualification Criteria  
Subject must have mild to moderate facial acne (score of 2-3 on FDA Investigator’s Global 
Assessment Scale, at least 5 inflammatory lesions, and 10-100 non-inflammatory lesions  
Does the subject have mild to moderate facial acne? 
 Yes      Score:  ___ 
 No 
Does the subject have at least 5 inflammatory lesions? 
 Yes  (>5)     
 No 
Does the subject have 10 – 100 non-inflammatory lesions? 
 Yes  (10-100) * 
 No 
Technician initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
*Tolerability Instructions: Local cutaneous tolerability will be evaluated by assessing the signs and 
symptoms of erythema, dryness, and scaling, and by subject reporting of the degree of 
stinging/burning on the global face (treatment area). (Half-point scores may be used as necessary to 
more accurately describe the skin condition): 0 = none, 1 = mild, 2 = moderate, 3 = severe 
Parameter 
Global Face 
Enter 2 digits for all scores (ie 0.5, 1.0, 2.0) 
Erythema 
 
 
. 
 
 
Dryness 
 
 
. 
 
 
Scaling 
 
 
. 
 
 
Burning/Stinging 
 
 
. 
 
 
Evaluator’s initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
 
 


Page 5 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 1 –Screening   
                   
 
 
 
   
INCLUSION CRITERIA 
Yes 
No* 
1. Is a man or woman between the ages of 21 and 45 years of age at the 
time of enrollment. 
 
 
2. Has mild to moderate acne (score of 2-3 on FDA Investigator’s Global 
Assessment Scale) on the face. 
 
 
3. Have at least 5 inflammatory lesions. 
 
 
4. Have 10 – 100 non-inflammatory lesions. 
 
 
5. Is willing to use the test products as instructed for 24 weeks. 
 
 
6. Has a Fitzpatrick skin type I-VI  
 
 
7. Is willing and able to comply with all of the time commitments and 
procedural requirements of the clinical trial protocol. 
 
 
8. Is willing to provide written informed consent including photo release, 
Health Insurance Portability and Accountability Act (HIPAA), and is able 
to read, speak, write, understand English and is willing to share 
personal information and data, as verified by signing a written 
authorization at the screening 
 
 
9. Is willing to withhold all facial treatments during the course of the 
study including botulinum toxin, injectable fillers, microdermabrasion, 
IPL, peels, facials, laser treatments and tightening treatments.  Waxing 
and threading is allowed but not facial laser hair removal. 
 
 
10. If male, who is a regular shaver and willing to shave on the day of the 
study visits (prior to clinic visits). 
 
 
11. If a woman of child bearing potential, is willing to take a urine 
pregnancy test prior to study enrollment, at week 24, and when 
deemed appropriate by the Investigator and/or Sponsor. 
 
 
12. Is of child bearing potential who uses an acceptable method of 
contraception throughout the study.  Acceptable methods of birth 
control include 
 Oral and other system contraceptives. Individuals must be on a 
stable use for 3 months prior to study enrollment. Individuals on 
oral contraceptives must not alter their use, including dose or 
regimen for the duration of the study 
 Double barrier 
 Bilateral tubal ligation 
 Partner vasectomy 
 Abstinence 
 
 
13. Is willing to follow study requirements and report any changes in 
health status or medications, adverse event symptoms, or reactions 
immediately. 
 
 
14. Must be stable on any medication they are taking for at least 30 days 
 
 
*If any criterion is answered no*, DO NOT enroll the subject. 


Page 6 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
 
Visit 1 –Screening  
  
                   
 
 
 
EXCLUSION CRITERIA  
Yes* 
No 
1. Has been diagnosed with allergies to topical acne products. 
 
 
2. Has a condition and/or disease of the skin that the Investigator deems 
inappropriate for participation. 
 
 
3. Is nursing, pregnant, or planning to become pregnant during the study. 
 
 
4. Have pre-existing or dormant dermatologic conditions on the face (e.g., 
psoriasis, rosacea, eczema, seborrheic dermatitis, severe excoriations etc.) 
which in the opinion of the Investigator could interfere with the outcome 
of the study. 
 
 
5. Has a history of immunosuppression/immune deficiency disorders 
(including (HIV infection or AIDS) or currently using immunosuppressive 
medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, 
Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, 
Remicade, Stelara.). 
 
 
6. Has an uncontrolled disease such as asthma, diabetes, hypertension, 
hyperthyroidism, or hypothyroidism. Individuals having multiple health 
conditions may be excluded from participation even if the conditions are 
controlled by diet, medication, etc. at the Investigator’s discretion. 
 
 
7. Is currently participating in another facial usage study or has participated 
in a clinical trial at Stephens or at another research facility or doctor’s 
office within 4 weeks prior to inclusion into the study. 
 
 
8. Has a history of skin cancer within the past 5 years. 
 
 
9. Has any planned surgeries and/or invasive medical procedures during the 
course of the study. 
 
 
10. Has started hormone replacement therapies (HRT) or hormones for birth 
control less than 3 months prior to study entry or plans on starting, 
stopping, or changing doses of HRT or hormones for birth control during 
the study. 
 
 
11. Has facial sunburn or excessive tanned facial skin or is not willing to avoid 
daily sun exposure on the face and the use of tanning beds or sunless 
tanning products for the duration of the study. 
 
 
12. Has severe acne, acne conglobata, multiple nodules or cysts (more than 2). 
 
 
13. Is currently taking a natural or prescription testosterone blocker (e.g. saw 
palmetto, blask cohosh, chaste tree, chasteberry, spironolactone, 
drospirenone, progestins). 
 
 
14. Is currently on a testosterone booster or prescription testosterone (e.g. 
DHEA, tribulus, testosterone cypionate, testosterone enanthate, Sustanon, 
testosterone propionate, testosterone phenylpropriate, Omnadren etc.). 
 
 
 (CONTINUED ON NEXT PAGE) 
 
 
 


Page 7 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
 
 


Page 8 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 1 –Screening   
 
                   
 
 
 
EXCLUSION CRITERIA CONTINUED 
Yes* 
No 
15. Is currently taking or has taken within the last 30 days oral or topical 
prescription medications for acne such as Doxycycline, Minocycline, 
Clindamycin, Bactrim, Tetracycline, Erythromycin, Vibramycin and topical 
tretinoin.(Retin A Renova, Adapalene, Tazarotene), Azelaic acid, benzoyl 
peroxide, Dapsone, Sodium sulfacetamide, Differin, Epiduo. 
 
 
16. Has used oral isotretinoin (Accutane) within the past 6-months. 
 
 
17. Is routinely using (3x a week or more) topical OTC acne product (e.g. 
benzoyl peroxide, salicylic acid, alpha hydroxyl, beta hydroxyl and/or poly-
hydroxy products or medicated cleansers, wipes, masks, scrubs, gels and 
creams) within 30 days of the study entry. 
 
 
18. Is using or has used any systemic medication considered to affect the 
course of acne, specifically, but not exclusively antibiotics or steroids 
within the last 30 days prior to entry into the study. 
 
 
19. Has excessive facial hair, including beard, mustache or goatee, or scars, 
which could interfere with evaluations by Investigator or designee. 
 
 
*If any criterion is answered Yes*, DO NOT enroll the subject. 
 
Urine Pregnancy Test  
If the candidate subject qualifies and is female of child-bearing potential, conduct a urine pregnancy 
test. Candidate female subjects with negative results, females of non-child-bearing potential, or 
candidate males that qualify will proceed to the next step. 
Test Results 
Reason Not Applicable 
Kit Lot # 
Kit Expiration date 
 Neg   Pos  N/A 
 
 
 
Technician initials:__________   Time: _____:_____AM/PM     Date(DD-MMM-YYYY):_______________ _ 
 
 
 
 
 
 
 
 
 


Page 9 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 1 –Screening   
 
INCLUSION/EXCLUSION  
Is the subject eligible per Inclusion/Exclusion criteria? 
 
 Yes       
 
 No   If no, please indicate which Inclusion/Exclusion criteria the subject did not meet and complete 
End of Study page: 
 
                Inclusion #_____________     Exclusion #________________ 
 
 
 
Investigators review 
I affirm that all required information has been reviewed by me, deemed accurate and complete and 
that the subject meets the inclusion/exclusion criteria, and is eligible to be enrolled in the study.  
 
_____________________________________________     ______-________-____________ 
Investigator’s Signature                                                                  DD         MMM            YYYY 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Page 10 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
 
Visit 2 –Baseline   
                   
 
 
Visit Date:  _____-_____-_____ 
                                                                                                                               DD-MMM-YYYY 
Check In Procedures 
Has the subject cleansed their face and removed all makeup at least 30 minutes prior?  
 Yes                          No (If no, subject needs to remove residual makeup and acclimate 20 minutes) 
 
Review of Adverse Events 
Has the subject experienced an Adverse Events or medical problems since their last visit?  
 Yes (If yes, record on AE page)            No 
 
Has the subject started or discontinued any concomitant medication since their last visit?  
 Yes (If yes, record on Medications page)            No 
 
Has the subject had any procedures or treatments since their last visit? 
 Yes (If yes, record on Medications page)            No 
 
Acclimation 
*Reminder: Subject must acclimate for at least 15 minutes in temperature of 68-75°F and relative 
humidity range 35-65% before starting assessments,  and photography procedures. 
Acclimation start time :_______:_______ AM/PM 
Acclimation end time :_______:_______ AM/PM 
Technician initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
Qualification Criteria  (confirm that subject still meets eligibility criteria) 
Subject must have mild to moderate facial acne (score of 2-3 on FDA Investigator’s Global 
Assessment Scale, at least 5 inflammatory lesions, and 10-100 non-inflammatory lesions  
Does the subject have mild to moderate facial acne? 
 Yes      Score:  ___ 
 No 
Does the subject have at least 5 inflammatory lesions? 
 Yes  (>5) *    
 No 
Does the subject have 10 – 100 non-inflammatory lesions? 
 Yes  (10-100) *    
 No 
*If yes, please fill out lesion count on page 10 
Evaluator’s initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
 
 


Page 11 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 2 –Baseline   
                   
 
 
 
 
Lesion Count 
A trained grader will count and record the number of open comedones, closed comedones, papules, and 
pustules on each subject’s face. Note that papules and pustules are classified as inflammatory acne 
lesions while open and closed comedones are classified as non-inflammatory lesions. 
*Lesions on the nose, under the jaw line or along the hairline (including eye brows) will not 
be included in the counts. 
Parameter 
Forehead 
Enter 2 digits 
for all scores (ie 
05, 10, 20) 
Left Cheek 
Enter 2 digits 
for all scores 
(ie 05, 10, 20) 
Chin 
Enter 2 digits for 
all scores (ie 05, 
10, 20) 
Right Cheek 
Enter 2 digits for 
all scores (ie 05, 
10, 20) 
Total 
Enter 3 digits for all 
scores (ie 050, 099, 
100) 
Open  Comedones 
 
 
 
 
 
 
 
 
 
 
 
Closed 
Comedones 
 
 
 
 
 
 
 
 
 
 
 
Papules 
 
 
 
 
 
 
 
 
 
 
 
Pustules 
 
 
 
 
 
 
 
 
 
 
 
Total 
 
 
 
 
 
 
 
 
 
 
 
Evaluator’s initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
Investigator’s Global Assessment (IGA) 
A trained grader will evaluate each subject’s global face for Investigator’s Global Improvement 
Assessment. 
Scale: 
0 
Clear 
No inflammatory or non-inflammatory lesions 
1 
Almost Clear 
Rare non-inflammatory lesions with no more than one small inflammatory 
lesion 
2 
Mild 
Greater than Grade 1, some non-inflammatory lesions with no more than a 
few inflammatory lesion (papules/pustules only, no nodular lesions) 
3 
Moderate 
Greater than Grade 2, up to many non-inflammatory lesions and may have 
some inflammatory lesions, but no more than one small nodular lesion 
4 
Severe 
Greater than Grade 3, up to many non-inflammatory and inflammatory 
lesions, but no more than a few nodular lesions 
 
Parameter 
Global Face 
Enter 1 digit for all scores (ie 1, 2, 3) 
IGA 
 
 
 
Evaluator’s initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
 
 


Page 12 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 2 –Baseline   
 
                   
 
 
 
*Tolerability Instructions: Local cutaneous tolerability will be evaluated by assessing the signs and 
symptoms of erythema, dryness, and scaling, and by subject reporting of the degree of 
stinging/burning on the global face (treatment area). (Half-point scores may be used as necessary to 
more accurately describe the skin condition): 0 = none, 1 = mild, 2 = moderate, 3 = severe 
Parameter 
Global Face 
Enter 2 digits for all scores (ie 0.5, 1.0, 2.0) 
Erythema 
 
 
. 
 
 
Dryness 
 
 
. 
 
 
Scaling 
 
 
. 
 
 
Burning/Stinging 
 
 
. 
 
 
Evaluator’s initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
VISIA Imaging – 1   2   3 Stephens TX site only, delete if not needed 
*Reminder: Subject must have a clean face (no makeup) and all jewelry removed. Subject must be 
wearing a black or gray matte headband to keep hair away from the face. Subject must be wearing a 
black matte shirt or draped with a black or gray matte cloth to hide clothing. Subjects must have a 
neutral, non-smiling expression with their eyes gently closed in all pictures. 
Please mark the box for each photo that was taken.  If one was not taken, leave box unmarked. 
Left View: 
 Standard Lighting 1 (visible) 
 Standard Lighting 2 (visible) 
Cross Polarized 
Parallel Polarized 
 UV Fluorescence 
Center View: 
 Standard Lighting 1 (visible) 
 Standard Lighting 2 (visible) 
Cross Polarized 
Parallel Polarized 
 UV Fluorescence 
Right View: 
 Standard Lighting 1 (visible) 
 Standard Lighting 2 (visible) 
Cross Polarized 
Parallel Polarized 
UV Fluorescence 
Seat height: _____ cm 
Headrest:   1      2      3   (circle one) 
Technician initials:__________   Time: _____:_____AM/PM     Date(DD-MMM-YYYY):_______________ _ 
 
 
 
 
 
 
 
Visit 2 – Baseline   


Page 13 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visible Light Imaging (Beauty shot) Stephens sites only, delete if not needed 
For subjects completing at sites 1 and 2 (Stephens’ Texas and Colorado locations), digital images will 
be taken of each subject’s face using visible light. Full-face images will be taken of each subject’s 
center view. Subjects will not be wearing any headband or using any headrest/chinrest. Subjects will 
be instructed to adopt neutral, non-smiling expressions with their eyes open. 
Please mark the box for each photo that was taken.  If one was not taken, leave box unmarked. 
Center View: 
 Visible light 
Seat height: _____                   Camera height: _____ 
 
Technician initials:__________   Time: _____:_____AM/PM     Date(DD-MMM-YYYY):_______________ _ 
 
Product Distribution 
 
Randomization Group:  A / B (circle one) 
Was the subject provided instructions on how to properly use the study products? 
 Yes 
 No 
Was the subject provided with a daily diary to record product application? 
 Yes 
 No 
Was the subject instructed to bring back the dispensed study products at the next 
visit? 
 Yes 
 No 
 
Technician initials:__________   Time: _____:_____AM/PM     Date(DD-MMM-YYYY):_______________ _ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Page 14 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit  3 – Week  1                                                                       Visit Date:  _____-_____-_____ 
                                                                                                                               DD-MMM-YYYY 
 
Check In Procedures 
Has the subject cleansed their face and removed all makeup at least 30 minutes prior?  
 Yes                          No (If no, subject needs to remove residual makeup and acclimate 20 minutes) 
 
Have the subject’s test materials been visually inspected and weighed? Record weights in Test Material Sheet 
 Yes                          No 
 
Has the subject’s diary been reviewed for compliance? 
 Yes                          No 
 
Has the subject been instructed to bring back the dispensed study products at the next visit? 
 Yes                          No 
 
Review of Adverse Events 
Has the subject experienced an Adverse Events or medical problems since their last visit?  
 Yes (If yes, record on AE page)            No 
 
Has the subject started or discontinued any concomitant medication since their last visit?  
 Yes (If yes, record on Medications page)            No 
 
Has the subject had any procedures or treatments since their last visit? 
 Yes (If yes, record on Medications page)            No 
 
Acclimation 
*Reminder: Subject must acclimate for at least 15 minutes in temperature of 68-75°F and relative 
humidity range 35-65% before starting assessments,  and photography procedures. 
Acclimation start time :_______:_______ AM/PM 
Acclimation end time :_______:_______ AM/PM 
 
Technician initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
 
 


Page 15 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 3 – Week  1                                                                   Visit Date:  _____-_____-_____ 
                                                                                                                           DD-MMM-YYYY 
Lesion Count 
A trained grader will count and record the number of open comedones, closed comedones, papules, and 
pustules on each subject’s face. Note that papules and pustules are classified as inflammatory acne 
lesions while open and closed comedones are classified as non-inflammatory lesions. 
*Lesions on the nose, under the jaw line or along the hairline (including eye brows) will not 
be included in the counts. 
Parameter 
Forehead 
Enter 2 digits 
for all scores (ie 
05, 10, 20) 
Left Cheek 
Enter 2 digits 
for all scores 
(ie 05, 10, 20) 
Chin 
Enter 2 digits for 
all scores (ie 05, 
10, 20) 
Right Cheek 
Enter 2 digits for 
all scores (ie 05, 
10, 20) 
Total 
Enter 3 digits for all 
scores (ie 050, 099, 
100) 
Open  Comedones 
 
 
 
 
 
 
 
 
 
 
 
Closed 
Comedones 
 
 
 
 
 
 
 
 
 
 
 
Papules 
 
 
 
 
 
 
 
 
 
 
 
Pustules 
 
 
 
 
 
 
 
 
 
 
 
Total 
 
 
 
 
 
 
 
 
 
 
 
Evaluator’s initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
Investigator’s Global Assessment (IGA) 
A trained grader will evaluate each subject’s global face for Investigator’s Global Improvement 
Assessment. 
Scale: 
0 
Clear 
No inflammatory or non-inflammatory lesions 
1 
Almost Clear 
Rare non-inflammatory lesions with no more than one small inflammatory 
lesion 
2 
Mild 
Greater than Grade 1, some non-inflammatory lesions with no more than a 
few inflammatory lesion (papules/pustules only, no nodular lesions) 
3 
Moderate 
Greater than Grade 2, up to many non-inflammatory lesions and may have 
some inflammatory lesions, but no more than one small nodular lesion 
4 
Severe 
Greater than Grade 3, up to many non-inflammatory and inflammatory 
lesions, but no more than a few nodular lesions 
 
Parameter 
Global Face 
Enter 1 digit for all scores (ie 1, 2, 3) 
IGA 
 
 
 
 
Evaluator’s initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
 


Page 16 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 3 – Week  1                                                                    
*Tolerability Instructions: Local cutaneous tolerability will be evaluated by assessing the signs and 
symptoms of erythema, dryness, and scaling, and by subject reporting of the degree of 
stinging/burning on the global face (treatment area). (Half-point scores may be used as necessary to 
more accurately describe the skin condition): 0 = none, 1 = mild, 2 = moderate, 3 = severe 
Parameter 
Global Face 
Enter 2 digits for all scores (ie 0.5, 1.0, 2.0) 
Erythema 
 
 
. 
 
 
Dryness 
 
 
. 
 
 
Scaling 
 
 
. 
 
 
Burning/Stinging 
 
 
. 
 
 
 
Evaluator’s initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
Self-Assessment Questionnaire 
Has the subject completed the self-assessment questionnaire? 
 Yes 
 No 
 
Technician initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
 
 


Page 17 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 4 – Week  2                                                                   Visit Date:  _____-_____-_____ 
                                                                                                                           DD-MMM-YYYY 
Check In Procedures 
Has the subject cleansed their face and removed all makeup at least 30 minutes prior?  
 Yes                          No (If no, subject needs to remove residual makeup and acclimate 20 minutes) 
 
Have the subject’s test materials been visually inspected and weighed? Record weights in Test Material Sheet 
 Yes                          No 
 
Has the subject’s diary been reviewed for compliance? 
 Yes                          No 
 
Has the subject been instructed to bring back the dispensed study products at the next visit? 
 Yes                          No 
 
Review of Adverse Events 
Has the subject experienced an Adverse Events or medical problems since their last visit?  
 Yes (If yes, record on AE page)            No 
 
Has the subject started or discontinued any concomitant medication since their last visit?  
 Yes (If yes, record on Medications page)            No 
 
Has the subject had any procedures or treatments since their last visit? 
 Yes (If yes, record on Medications page)            No 
 
Acclimation 
*Reminder: Subject must acclimate for at least 15 minutes in temperature of 68-75°F and relative 
humidity range 35-65% before starting assessments,  and photography procedures. 
Acclimation start time :_______:_______ AM/PM 
Acclimation end time :_______:_______ AM/PM 
 
Technician initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
 
 


Page 18 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 4 – Week  2                                                                    
Lesion Count 
A trained grader will count and record the number of open comedones, closed comedones, papules, and 
pustules on each subject’s face. Note that papules and pustules are classified as inflammatory acne 
lesions while open and closed comedones are classified as non-inflammatory lesions. 
*Lesions on the nose, under the jaw line or along the hairline (including eye brows) will not 
be included in the counts. 
Parameter 
Forehead 
Enter 2 digits 
for all scores (ie 
05, 10, 20) 
Left Cheek 
Enter 2 digits 
for all scores 
(ie 05, 10, 20) 
Chin 
Enter 2 digits for 
all scores (ie 05, 
10, 20) 
Right Cheek 
Enter 2 digits for 
all scores (ie 05, 
10, 20) 
Total 
Enter 3 digits for all 
scores (ie 050, 099, 
100) 
Open  Comedones 
 
 
 
 
 
 
 
 
 
 
 
Closed 
Comedones 
 
 
 
 
 
 
 
 
 
 
 
Papules 
 
 
 
 
 
 
 
 
 
 
 
Pustules 
 
 
 
 
 
 
 
 
 
 
 
Total 
 
 
 
 
 
 
 
 
 
 
 
Evaluator’s initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
Investigator’s Global Assessment (IGA) 
A trained grader will evaluate each subject’s global face for Investigator’s Global Improvement 
Assessment. 
Scale: 
0 
Clear 
No inflammatory or non-inflammatory lesions 
1 
Almost Clear 
Rare non-inflammatory lesions with no more than one small inflammatory 
lesion 
2 
Mild 
Greater than Grade 1, some non-inflammatory lesions with no more than a 
few inflammatory lesion (papules/pustules only, no nodular lesions) 
3 
Moderate 
Greater than Grade 2, up to many non-inflammatory lesions and may have 
some inflammatory lesions, but no more than one small nodular lesion 
4 
Severe 
Greater than Grade 3, up to many non-inflammatory and inflammatory 
lesions, but no more than a few nodular lesions 
 
Parameter 
Global Face 
Enter 1 digit for all scores (ie 1, 2, 3) 
IGA 
 
 
 
 
Evaluator’s initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
 
 


Page 19 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 4 – Week  2                                                                    
*Tolerability Instructions: Local cutaneous tolerability will be evaluated by assessing the signs and 
symptoms of erythema, dryness, and scaling, and by subject reporting of the degree of 
stinging/burning on the global face (treatment area). (Half-point scores may be used as necessary to 
more accurately describe the skin condition): 0 = none, 1 = mild, 2 = moderate, 3 = severe 
Parameter 
Global Face 
Enter 2 digits for all scores (ie 0.5, 1.0, 2.0) 
Erythema 
 
 
. 
 
 
Dryness 
 
 
. 
 
 
Scaling 
 
 
. 
 
 
Burning/Stinging 
 
 
. 
 
 
 
Evaluator’s initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
Self-Assessment Questionnaire 
Has the subject completed the self-assessment questionnaire? 
 Yes 
 No 
 
Technician initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
 
 


Page 20 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 5 – Week  6                                                                   Visit Date:  _____-_____-_____ 
                                                                                                                           DD-MMM-YYYY 
Check In Procedures 
Has the subject cleansed their face and removed all makeup at least 30 minutes prior?  
 Yes                          No (If no, subject needs to remove residual makeup and acclimate 20 minutes) 
 
Have the subject’s test materials been visually inspected and weighed? Record weights in Test Material Sheet 
 Yes                          No 
 
Has the subject’s diary been reviewed for compliance? 
 Yes                          No 
 
Has the subject been given a new diary? 
 Yes                          No 
 
Has the subject been instructed to bring back the dispensed study products at the next visit? 
 Yes                          No 
 
Review of Adverse Events 
Has the subject experienced an Adverse Events or medical problems since their last visit?  
 Yes (If yes, record on AE page)            No 
 
Has the subject started or discontinued any concomitant medication since their last visit?  
 Yes (If yes, record on Medications page)            No 
 
Has the subject had any procedures or treatments since their last visit? 
 Yes (If yes, record on Medications page)            No 
 
Acclimation 
*Reminder: Subject must acclimate for at least 15 minutes in temperature of 68-75°F and relative 
humidity range 35-65% before starting assessments,  and photography procedures. 
Acclimation start time :_______:_______ AM/PM 
Acclimation end time :_______:_______ AM/PM 
 
Technician initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
 
 


Page 21 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 5 – Week  6                                                                    
VISIA Imaging 
*Reminder: Subject must have a clean face (no makeup) and all jewelry removed. Subject must be 
wearing a black or gray matte headband to keep hair away from the face. Subject must be wearing a 
black matte shirt or draped with a black or gray matte cloth to hide clothing. Subjects must have a 
neutral, non-smiling expression with their eyes gently closed in all pictures. 
Please mark the box for each photo that was taken.  If one was not taken, leave box unmarked. 
Left View: 
 Standard Lighting 1 (visible) 
 Standard Lighting 2 (visible) 
Cross Polarized 
Parallel Polarized 
 UV Fluorescence 
Center View: 
 Standard Lighting 1 (visible) 
 Standard Lighting 2 (visible) 
Cross Polarized 
Parallel Polarized 
 UV Fluorescence 
Right View: 
 Standard Lighting 1 (visible) 
 Standard Lighting 2 (visible) 
Cross Polarized 
Parallel Polarized 
 UV Fluorescence 
Seat height: _____ cm 
Headrest:   1      2      3   (circle one) 
 
Technician initials:__________   Time: _____:_____AM/PM     Date(DD-MMM-YYYY):_______________ _ 
 
 
 
 


Page 22 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 5 – Week  6                                                                    
Lesion Count 
A trained grader will count and record the number of open comedones, closed comedones, papules, and 
pustules on each subject’s face. Note that papules and pustules are classified as inflammatory acne 
lesions while open and closed comedones are classified as non-inflammatory lesions. 
*Lesions on the nose, under the jaw line or along the hairline (including eye brows) will not 
be included in the counts. 
Parameter 
Forehead 
Enter 2 digits 
for all scores (ie 
05, 10, 20) 
Left Cheek 
Enter 2 digits 
for all scores 
(ie 05, 10, 20) 
Chin 
Enter 2 digits for 
all scores (ie 05, 
10, 20) 
Right Cheek 
Enter 2 digits for 
all scores (ie 05, 
10, 20) 
Total 
Enter 3 digits for all 
scores (ie 050, 099, 
100) 
Open  Comedones 
 
 
 
 
 
 
 
 
 
 
 
Closed 
Comedones 
 
 
 
 
 
 
 
 
 
 
 
Papules 
 
 
 
 
 
 
 
 
 
 
 
Pustules 
 
 
 
 
 
 
 
 
 
 
 
Total 
 
 
 
 
 
 
 
 
 
 
 
Evaluator’s initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
Investigator’s Global Assessment (IGA) 
A trained grader will evaluate each subject’s global face for Investigator’s Global Improvement 
Assessment. 
Scale: 
0 
Clear 
No inflammatory or non-inflammatory lesions 
1 
Almost Clear 
Rare non-inflammatory lesions with no more than one small inflammatory 
lesion 
2 
Mild 
Greater than Grade 1, some non-inflammatory lesions with no more than a 
few inflammatory lesion (papules/pustules only, no nodular lesions) 
3 
Moderate 
Greater than Grade 2, up to many non-inflammatory lesions and may have 
some inflammatory lesions, but no more than one small nodular lesion 
4 
Severe 
Greater than Grade 3, up to many non-inflammatory and inflammatory 
lesions, but no more than a few nodular lesions 
 
Parameter 
Global Face 
Enter 1 digit for all scores (ie 1, 2, 3) 
IGA 
 
 
 
 
Evaluator’s initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
 
 


Page 23 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 5  – Week  6                                                                    
*Tolerability Instructions: Local cutaneous tolerability will be evaluated by assessing the signs and 
symptoms of erythema, dryness, and scaling, and by subject reporting of the degree of 
stinging/burning on the global face (treatment area). (Half-point scores may be used as necessary to 
more accurately describe the skin condition): 0 = none, 1 = mild, 2 = moderate, 3 = severe 
Parameter 
Global Face 
Enter 2 digits for all scores (ie 0.5, 1.0, 2.0) 
Erythema 
 
 
. 
 
 
Dryness 
 
 
. 
 
 
Scaling 
 
 
. 
 
 
Burning/Stinging 
 
 
. 
 
 
 
Technician initials:__________   Date (DD-MMM-YYYY):_______________ _ 
 
Self-Assessment Questionnaire 
Has the subject completed the self-assessment questionnaire? 
 Yes 
 No 
 
Technician initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
 
 


Page 24 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Follow-up Phone Call (between Week 6 and Week 12) 
Review of Adverse Events 
Has the subject experienced an Adverse Events or medical problems since their last visit?  
 Yes (If yes, record on AE page)            No 
 
Has the subject started or discontinued any concomitant medication since their last visit?  
 Yes (If yes, record on Medications page)            No 
 
Has the subject had any procedures or treatments since their last visit? 
 Yes (If yes, record on Medications page)            No 
 
Does the subject have enough study product to until the next study visit? 
 Yes            No 
 
Technician initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
 
 


Page 25 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 6 – Week  12                                                                   Visit Date:  _____-_____-_____ 
                                                                                                                           DD-MMM-YYYY 
Check In Procedures 
Has the subject cleansed their face and removed all makeup at least 30 minutes prior?  
 Yes                          No (If no, subject needs to remove residual makeup and acclimate 20 minutes) 
 
Have the subject’s test materials been visually inspected and weighed? Record weights in Test Material Sheet 
 Yes                          No 
 
Has the subject’s diary been reviewed for compliance? 
 Yes                          No 
 
Has the subject been given a new diary? 
 Yes                          No 
 
Has the subject been instructed to bring back the dispensed study products at the next visit? 
 Yes                          No 
 
Review of Adverse Events 
Has the subject experienced an Adverse Events or medical problems since their last visit?  
 Yes (If yes, record on AE page)            No 
 
Has the subject started or discontinued any concomitant medication since their last visit?  
 Yes (If yes, record on Medications page)            No 
 
Has the subject had any procedures or treatments since their last visit? 
 Yes (If yes, record on Medications page)            No 
 
Acclimation 
*Reminder: Subject must acclimate for at least 15 minutes in temperature of 68-75°F and relative 
humidity range 35-65% before starting assessments,  and photography procedures. 
Acclimation start time :_______:_______ AM/PM 
Acclimation end time :_______:_______ AM/PM 
 
Technician initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
 
 


Page 26 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 6 – Week  12                                                                    
VISIA Imaging 
*Reminder: Subject must have a clean face (no makeup) and all jewelry removed. Subject must be 
wearing a black or gray matte headband to keep hair away from the face. Subject must be wearing a 
black matte shirt or draped with a black or gray matte cloth to hide clothing. Subjects must have a 
neutral, non-smiling expression with their eyes gently closed in all pictures. 
Please mark the box for each photo that was taken.  If one was not taken, leave box unmarked. 
Left View: 
 Standard Lighting 1 (visible) 
 Standard Lighting 2 (visible) 
Cross Polarized 
Parallel Polarized 
 UV Fluorescence 
Center View: 
 Standard Lighting 1 (visible) 
 Standard Lighting 2 (visible) 
Cross Polarized 
Parallel Polarized 
 UV Fluorescence 
Right View: 
 Standard Lighting 1 (visible) 
 Standard Lighting 2 (visible) 
Cross Polarized 
Parallel Polarized 
 UV Fluorescence 
Seat height: _____ cm 
Headrest:   1      2      3   (circle one) 
 
Technician initials:__________   Time: _____:_____AM/PM     Date(DD-MMM-YYYY):_______________ _ 
  
Visible Light Imaging (Beauty shot) Stephens sites only, delete if not needed 
For subjects completing at sites 1 and 2 (Stephens’ Texas and Colorado locations), digital images will 
be taken of each subject’s face using visible light. Full-face images will be taken of each subject’s 
center view. Subjects will not be wearing any headband or using any headrest/chinrest. Subjects will 
be instructed to adopt neutral, non-smiling expressions with their eyes open. 
Please mark the box for each photo that was taken.  If one was not taken, leave box unmarked. 
Center View: 
 Visible light 
Seat height: _____                   Camera height: _____ 
 
Technician initials:__________   Time: _____:_____AM/PM     Date(DD-MMM-YYYY):_______________ _ 
 
 
 


Page 27 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 6 – Week  12                                                                    
Lesion Count 
A trained grader will count and record the number of open comedones, closed comedones, papules, and 
pustules on each subject’s face. Note that papules and pustules are classified as inflammatory acne 
lesions while open and closed comedones are classified as non-inflammatory lesions. 
*Lesions on the nose, under the jaw line or along the hairline (including eye brows) will not 
be included in the counts. 
Parameter 
Forehead 
Enter 2 digits 
for all scores (ie 
05, 10, 20) 
Left Cheek 
Enter 2 digits 
for all scores 
(ie 05, 10, 20) 
Chin 
Enter 2 digits for 
all scores (ie 05, 
10, 20) 
Right Cheek 
Enter 2 digits for 
all scores (ie 05, 
10, 20) 
Total 
Enter 3 digits for all 
scores (ie 050, 099, 
100) 
Open  Comedones 
 
 
 
 
 
 
 
 
 
 
 
Closed 
Comedones 
 
 
 
 
 
 
 
 
 
 
 
Papules 
 
 
 
 
 
 
 
 
 
 
 
Pustules 
 
 
 
 
 
 
 
 
 
 
 
Total 
 
 
 
 
 
 
 
 
 
 
 
Evaluator’s initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
Investigator’s Global Assessment (IGA) 
A trained grader will evaluate each subject’s global face for Investigator’s Global Improvement 
Assessment. 
Scale: 
0 
Clear 
No inflammatory or non-inflammatory lesions 
1 
Almost Clear 
Rare non-inflammatory lesions with no more than one small inflammatory 
lesion 
2 
Mild 
Greater than Grade 1, some non-inflammatory lesions with no more than a 
few inflammatory lesion (papules/pustules only, no nodular lesions) 
3 
Moderate 
Greater than Grade 2, up to many non-inflammatory lesions and may have 
some inflammatory lesions, but no more than one small nodular lesion 
4 
Severe 
Greater than Grade 3, up to many non-inflammatory and inflammatory 
lesions, but no more than a few nodular lesions 
 
Parameter 
Global Face 
Enter 1 digit for all scores (ie 1, 2, 3) 
IGA 
 
 
 
 
Evaluator’s initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
 
 


Page 28 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 6 – Week  12                                                                    
*Tolerability Instructions: Local cutaneous tolerability will be evaluated by assessing the signs and 
symptoms of erythema, dryness, and scaling, and by subject reporting of the degree of 
stinging/burning on the global face (treatment area). (Half-point scores may be used as necessary to 
more accurately describe the skin condition): 0 = none, 1 = mild, 2 = moderate, 3 = severe 
Parameter 
Global Face 
Enter 2 digits for all scores (ie 0.5, 1.0, 2.0) 
Erythema 
 
 
. 
 
 
Dryness 
 
 
. 
 
 
Scaling 
 
 
. 
 
 
Burning/Stinging 
 
 
. 
 
 
 
Evaluator’s initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
Self-Assessment Questionnaire 
Has the subject completed the self-assessment questionnaire? 
 Yes 
 No 
 
Technician initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
 
 


Page 29 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 7 – Week  18                                                                   Visit Date:  _____-_____-_____ 
                                                                                                                              DD-MMM-YYYY 
Check In Procedures 
Has the subject cleansed their face and removed all makeup at least 30 minutes prior?  
 Yes                          No (If no, subject needs to remove residual makeup and acclimate 20 minutes) 
 
Have the subject’s test materials been visually inspected and weighed? Record weights in Test Material Sheet 
 Yes                          No 
 
Has the subject’s diary been reviewed for compliance? 
 Yes                          No 
 
Has the subject been given a new diary? 
 Yes                          No 
 
Has the subject been instructed to bring back the dispensed study products at the next visit? 
 Yes                          No 
 
Review of Adverse Events 
Has the subject experienced an Adverse Events or medical problems since their last visit?  
 Yes (If yes, record on AE page)            No 
 
Has the subject started or discontinued any concomitant medication since their last visit?  
 Yes (If yes, record on Medications page)            No 
 
Has the subject had any procedures or treatments since their last visit? 
 Yes (If yes, record on Medications page)            No 
 
Technician initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
 
 


Page 30 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 8 – Week  24                                                                   Visit Date:  _____-_____-_____ 
                                                                                                                             DD-MMM-YYYY 
Check In Procedures 
Has the subject cleansed their face and removed all makeup at least 30 minutes prior?  
 Yes                          No (If no, subject needs to remove residual makeup and acclimate 20 minutes) 
 
Have the subject’s test materials been visually inspected and weighed? Record weights in Test Material Sheet 
 Yes                          No 
 
Has the subject’s diary been reviewed for compliance? 
 Yes                          No 
 
Review of Adverse Events 
Has the subject experienced an Adverse Events or medical problems since their last visit?  
 Yes (If yes, record on AE page)            No 
 
Has the subject started or discontinued any concomitant medication since their last visit?  
 Yes (If yes, record on Medications page)            No 
 
Has the subject had any procedures or treatments since their last visit? 
 Yes (If yes, record on Medications page)            No 
 
Acclimation 
*Reminder: Subject must acclimate for at least 15 minutes in temperature of 68-75°F and relative 
humidity range 35-65% before starting assessments,  and photography procedures. 
Acclimation start time :_______:_______ AM/PM 
Acclimation end time :_______:_______ AM/PM 
 
Technician initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
Urine Pregnancy Test  
If the subject is a female of child-bearing potential, conduct a urine pregnancy test.  
Test Results 
Reason Not Applicable 
Kit Lot # 
Kit Expiration date 
 Neg   Pos  N/A 
 
 
 
 
Technician initials:__________   Time: _____:_____AM/PM     Date(DD-MMM-YYYY):_______________ _ 
 
 
 


Page 31 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 8 – Week  24                                                                    
VISIA Imaging 
*Reminder: Subject must have a clean face (no makeup) and all jewelry removed. Subject must be 
wearing a black or gray matte headband to keep hair away from the face. Subject must be wearing a 
black matte shirt or draped with a black or gray matte cloth to hide clothing. Subjects must have a 
neutral, non-smiling expression with their eyes gently closed in all pictures. 
Please mark the box for each photo that was taken.  If one was not taken, leave box unmarked. 
Left View: 
 Standard Lighting 1 (visible) 
 Standard Lighting 2 (visible) 
Cross Polarized 
Parallel Polarized 
 UV Fluorescence 
Center View: 
 Standard Lighting 1 (visible) 
 Standard Lighting 2 (visible) 
Cross Polarized 
Parallel Polarized 
 UV Fluorescence 
Right View: 
 Standard Lighting 1 (visible) 
 Standard Lighting 2 (visible) 
Cross Polarized 
Parallel Polarized 
 UV Fluorescence 
Seat height: _____ cm 
Headrest:   1      2      3   (circle one) 
 
Technician initials:__________   Time: _____:_____AM/PM     Date(DD-MMM-YYYY):_______________ _ 
 
Visible Light Imaging (Beauty shot) – Stephens sites only, delete if not needed 
For subjects completing at sites 1 and 2 (Stephens’ Texas and Colorado locations), digital images will 
be taken of each subject’s face using visible light. Full-face images will be taken of each subject’s 
center view. Subjects will not be wearing any headband or using any headrest/chinrest. Subjects will 
be instructed to adopt neutral, non-smiling expressions with their eyes open. 
Please mark the box for each photo that was taken.  If one was not taken, leave box unmarked. 
Center View: 
 Visible light 
Seat height: _____                   Camera height: _____ 
 
Technician initials:__________   Time: _____:_____AM/PM     Date(DD-MMM-YYYY):_______________ _ 
 
 
 
 


Page 32 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 8 – Week  24                                                                    
Lesion Count 
A trained grader will count and record the number of open comedones, closed comedones, papules, and 
pustules on each subject’s face. Note that papules and pustules are classified as inflammatory acne 
lesions while open and closed comedones are classified as non-inflammatory lesions. 
*Lesions on the nose, under the jaw line or along the hairline (including eye brows) will not 
be included in the counts. 
Parameter 
Forehead 
Enter 2 digits 
for all scores (ie 
05, 10, 20) 
Left Cheek 
Enter 2 digits 
for all scores 
(ie 05, 10, 20) 
Chin 
Enter 2 digits for 
all scores (ie 05, 
10, 20) 
Right Cheek 
Enter 2 digits for 
all scores (ie 05, 
10, 20) 
Total 
Enter 3 digits for all 
scores (ie 050, 099, 
100) 
Open  Comedones 
 
 
 
 
 
 
 
 
 
 
 
Closed 
Comedones 
 
 
 
 
 
 
 
 
 
 
 
Papules 
 
 
 
 
 
 
 
 
 
 
 
Pustules 
 
 
 
 
 
 
 
 
 
 
 
Total 
 
 
 
 
 
 
 
 
 
 
 
Evaluator’s initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
Investigator’s Global Assessment (IGA) 
A trained grader will evaluate each subject’s global face for Investigator’s Global Improvement 
Assessment. 
Scale: 
0 
Clear 
No inflammatory or non-inflammatory lesions 
1 
Almost Clear 
Rare non-inflammatory lesions with no more than one small inflammatory 
lesion 
2 
Mild 
Greater than Grade 1, some non-inflammatory lesions with no more than a 
few inflammatory lesion (papules/pustules only, no nodular lesions) 
3 
Moderate 
Greater than Grade 2, up to many non-inflammatory lesions and may have 
some inflammatory lesions, but no more than one small nodular lesion 
4 
Severe 
Greater than Grade 3, up to many non-inflammatory and inflammatory 
lesions, but no more than a few nodular lesions 
 
Parameter 
Global Face 
Enter 1 digit for all scores (ie 1, 2, 3) 
IGA 
 
 
 
 
Evaluator’s initials:__________   Date (DD-MMM-YYYY):_______________ _ 
 
 
 


Page 33 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Visit 8 – Week  24                                                                    
*Tolerability Instructions: Local cutaneous tolerability will be evaluated by assessing the signs and 
symptoms of erythema, dryness, and scaling, and by subject reporting of the degree of 
stinging/burning on the global face (treatment area). (Half-point scores may be used as necessary to 
more accurately describe the skin condition): 0 = none, 1 = mild, 2 = moderate, 3 = severe 
Parameter 
Global Face 
Enter 2 digits for all scores (ie 0.5, 1.0, 2.0) 
Erythema 
 
 
. 
 
 
Dryness 
 
 
. 
 
 
Scaling 
 
 
. 
 
 
Burning/Stinging 
 
 
. 
 
 
 
Evaluator’s initials:__________   Date (DD-MMM-YYYY):_______________ _ 
 
Self-Assessment Questionnaire 
Has the subject completed the self-assessment questionnaire? 
 Yes 
 No 
 
Technician initials:____________________    Date(DD-MMM-YYYY):____________________ 
 
 
 


Page 34 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Test Material Sheet 
 
 
 
 
 
 
 
Kit #:_______ 
Date Dispensed: ___________ 
Date Returned: ____________ 
Pre-
Weight 
Week 12 
Product: A  B (check one) 
g 
g 
Facial Cleanser 
g 
g 
Moisturizing Lotion 
g 
g 
Facial Moisturizer SPF 30 
g 
g 
Staff Initials / Date 
 
Kit #:_______ 
Date Dispensed: ___________ 
Date Returned: ____________ 
Pre-
Weight 
Week 24 
Product: A  B (check one) 
g 
g 
Facial Cleanser 
g 
g 
Moisturizing Lotion 
g 
g 
Facial Moisturizer SPF 30 
g 
g 
Staff Initials / Date 
 
 
 
 
 
 
 
 
Kit #:_______ 
Date Dispensed: ___________ 
Date Returned: ____________ 
Pre-
Weight 
Week 1 
Week 2 
Week 6 
Product: A  B (check one) 
g 
g 
g 
g 
Facial Cleanser 
g 
g 
g 
g 
Moisturizing Lotion 
g 
g 
g 
g 
Facial Moisturizer SPF 30 
g 
g 
g 
g 
Staff Initials / Date 
Kit #:_______ 
Date Dispensed: ___________ 
Date Returned: ____________ 
Pre-
Weight 
Week 18 
Product: A  B (check one) 
g 
g 
Facial Cleanser 
g 
g 
Moisturizing Lotion 
g 
g 
Facial Moisturizer SPF 30 
g 
g 
Staff Initials / Date 
Kit #:_______ 
Date Dispensed: ___________ 
Date Returned: ____________ 
Pre-
Weight 
Unschedul
ed 
Product: A  B (check one) 
g 
g 
Facial Cleanser 
g 
g 
Moisturizing Lotion 
g 
g 
Facial Moisturizer SPF 30 
g 
g 
Staff Initials / Date 


Page 35 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Adverse Events                                                   
FROM TIME CONSENTED UNTIL STUDY EXIT 
Page  1  2  3  4  5  __ 
 Last Page 
Did the subject report any adverse events? Yes (complete form)        No (if no, leave the rest of the form blank) 
Adverse Event 
Onset Date 
DD-MMM-YYY 
Cessation Date 
DD-MMM-YYY 
Serious 
Severity 
Relation to 
Investigational  
product 
Action Taken with 
Investigational 
Product 
Treatment Taken 
If yes,  complete 
Concomitant 
medication form 
Outcome 
1. 
 
 
 
 
No 
Yes* 
Mild 
Moderate 
Severe 
 
Reasonable 
possibility 
No 
Reasonable 
possibility 
 
None 
Modified Use 
Interrupted 
Discontinued 
Not Applicable 
No 
Yes 
Resolved 
Ongoing 
Fatal 
Unknown 
 
2. 
 
 
 
 
No 
Yes* 
Mild 
Moderate 
Severe 
 
Reasonable 
possibility 
No 
Reasonable 
possibility 
 
None 
Modified Use 
Interrupted 
Discontinued 
Not Applicable 
No 
Yes 
Resolved 
Ongoing 
Fatal 
Unknown 
 
3. 
 
 
 
No 
Yes* 
Mild 
Moderate 
Severe 
 
Reasonable 
possibility 
No 
Reasonable 
possibility 
 
None 
Modified Use 
Interrupted 
Discontinued 
Not Applicable 
No 
Yes 
Resolved 
Ongoing 
Fatal 
Unknown 
 
4. 
 
 
 
No 
Yes* 
Mild 
Moderate 
Severe 
 
Reasonable 
possibility 
No 
Reasonable 
possibility 
 
None 
Modified Use 
Interrupted 
Discontinued 
Not Applicable 
No 
Yes 
Resolved 
Ongoing 
Fatal 
Unknown 
 
 
*Serious AEs only (must notify Sponsor within 24 hours):  
 
Death 
 Life Threatening 
Inpatient Hospitalization 
Prolonged Hospitalization 
Persistent or Significant disability/incapacity 
Congenital anomaly/birth defect 
Other Medically Important Event 
 
 
 


Page 36 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
END OF STUDY  
Date of Completion or Discontinuation (DD-MMM-YYYY) ____-______-______ 
Did the subject complete through Visit 7?        Yes          No 
If NO, mark primary reason for premature withdrawal: 
 Voluntary Withdrawal 
 Death 
 Pregnancy 
 Investigator decision that it is not the best medical interest of the subject to continue participation in 
the investigation  
 Adverse/ Serious Adverse Event #______ 
 Subject not following required study procedures 
 Requires disallowed Therapy 
 Lost to Follow-up 
 Occurrence of relevant exclusion Criteria 
 
 


Page 37 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
 
Contact Log 
Initials of person 
contacting the subject 
Date of 
contact 
(DD-MMM-YYYY) 
Reason for contact with subject 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Page 38 of 38 
 
Final Version 12APR2016 – 8 Visits 
Source Documents 
 
Galderma 
 
 
Study # C16-CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
 
SITE NUMBER 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Notes Page 
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________ 
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________ 
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________ 
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________ 
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________ 
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________ 
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________ 
 


 
 
 
 
AMENDED QUESTIONNAIRES 24MAY2016 
Source Documents 
 
Galderma 
 
 
Study # C16‐CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Week 1 
Questions 
1=Strongly 
Agree 
2 
3 
4 
5=Strongly 
Disagree 
This treatment works faster than my 
previous acne treatment. 
 
 
 
 
 
I feel that this treatment deep cleans and 
unblocks my pores. 
 
 
 
 
 
I noticed an improvement in my acne.  
 
 
 
 
 
I have noticed I had fewer breakouts than 
my previous treatments.                                      
 
 
 
 
 
I saw improvement in the overall health of 
my skin since starting the regimen     
 
 
 
 
 
This regimen is easy to use every day. 
 
 
 
 
 
I liked the feel of this product. 
 
 
 
 
 
 
 
 
 
 
_________________________________ 
Subject Initials and Date 
 
 


 
 
 
 
AMENDED QUESTIONNAIRES 24MAY2016 
Source Documents 
 
Galderma 
 
 
Study # C16‐CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Week 2 
Questions 
1=Strongly 
Agree 
2 
3 
4 
5=Strongly 
Disagree 
My skin is clearer skin using this treatment 
 
 
 
 
 
This treatment works faster than my 
previous acne treatment. 
 
 
 
 
 
I feel that this treatment deep cleans and 
unblocks my pores. 
 
 
 
 
 
I noticed an improvement in my acne. 
Strongly agree to Strongly disagree 
 
 
 
 
 
I have noticed I had fewer breakouts than 
my previous treatments.                                       
 
 
 
 
 
The areas of my skin where I used to have 
acne is now clear and radiant after daily 
treatment.                                                                
 
 
 
 
 
 
 
 
 
_________________________________ 
Subject Initials and Date 
 
 


 
 
 
 
AMENDED QUESTIONNAIRES 24MAY2016 
Source Documents 
 
Galderma 
 
 
Study # C16‐CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Week 6 
Questions 
1=Strongly 
Agree 
2 
3 
4 
5=Strongly 
Disagree 
My skin is clearer skin using this treatment 
 
 
 
 
 
I feel my skin is now clear 
 
 
 
 
 
The treatment helped to reduce redness and 
inflammation caused by my acne. 
 
 
 
 
 
I feel that this treatment deep cleans and 
unblocks my pores. 
 
 
 
 
 
This treatment visually minimized my pore 
size. 
 
 
 
 
 
This treatment reduces my acne without 
leaving behind dry, flakey skin. 
 
 
 
 
 
I have noticed I had fewer breakouts than 
my previous treatments.                                       
 
 
 
 
 
My skin looks better than before 
 
 
 
 
 
I saw improvement in the overall health of 
my skin since starting the regimen     
 
 
 
 
 
My skin looks noticeably smoother and 
healthier 
 
 
 
 
 
The areas of my skin where I used to have 
acne is now clear and radiant after daily 
treatment.                                                                
 
 
 
 
 
I feel better about my skin  since I’ve started 
the treatment regimen 
 
 
 
 
 
I feel more confident since I’ve started the 
treatment 
 
 
 
 
 
What is your overall satisfaction with the 
regimen? 
 
 
 
 
 
I have noticed a positive difference in the 
appearance of my skin with this regimen. 
 
 
 
 
 
This regimen is easy to use every day. 
 
 
 
 
 
 
 
 
_________________________________ 
Subject Initials and Date 
 
 


 
 
 
 
AMENDED QUESTIONNAIRES 24MAY2016 
Source Documents 
 
Galderma 
 
 
Study # C16‐CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Week 12 
Questions 
1=Strongly 
Agree 
2 
3 
4 
5=Strongly 
Disagree 
I experienced noticeable improvement in my 
skin tone 
 
 
 
 
 
I experienced noticeable improvement in my 
skin texture 
 
 
 
 
 
I experienced noticeable improvement in my 
skin radiance 
 
 
 
 
 
My skin has a more youthful appearance 
 
 
 
 
 
My skin is clearer skin using this treatment 
 
 
 
 
 
I feel my skin is now clear 
 
 
 
 
 
This treatment is strong enough to give me 
clear, acne free skin. 
 
 
 
 
 
The treatment helped to reduce redness and 
inflammation caused by my acne. 
 
 
 
 
 
This treatment visually minimized my pore 
size. 
 
 
 
 
 
This treatment reduces my acne without 
leaving behind dry, flakey skin. 
 
 
 
 
 
I have noticed I had fewer breakouts than 
my previous treatments.                                       
 
 
 
 
 
My skin looks better than before 
 
 
 
 
 
This treatment breaks my cycle of acne and 
keeps my skin clear                                                
 
 
 
 
 
I saw improvement in the overall health of 
my skin since starting the regimen     
 
 
 
 
 
My skin looks noticeably smoother and 
healthier 
 
 
 
 
 
The areas of my skin where I used to have 
acne is now clear and radiant after daily 
treatment.                                                                
 
 
 
 
 
I feel better about my skin  since I’ve started 
the treatment regimen 
 
 
 
 
 
I feel more confident since I’ve started the 
treatment 
 
 
 
 
 
 
 
_________________________________ 
Subject Initials and Date 
 
 


 
 
 
 
AMENDED QUESTIONNAIRES 24MAY2016 
Source Documents 
 
Galderma 
 
 
Study # C16‐CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Week 12 (cont.) 
Questions 
1=Strongly 
Agree 
2 
3 
4 
5=Strongly 
Disagree 
Has your quality of life improved now that 
you have started using this product? 
 
 
 
 
 
What is your overall satisfaction with the 
regimen? 
 
 
 
 
 
I have noticed a positive difference in the 
appearance of my skin with this regimen. 
 
 
 
 
 
I would recommend this product to others. 
 
 
 
 
 
My acne is as clear as if I went to a doctor or 
received a prescription. 
 
 
 
 
 
I don’t feel the need for a prescription after 
using this product. 
 
 
 
 
 
Do you feel this treatment is designed for 
you? 
 
 
 
 
 
Do you feel more positive and less 
frustrated about your acne and your skin 
since starting this treatment? 
 
 
 
 
 
Do you feel this treatment meets the needs 
of your skin? 
 
 
 
 
 
 
 
 
_________________________________ 
Subject Initials and Date 


 
 
 
 
AMENDED QUESTIONNAIRES 24MAY2016 
Source Documents 
 
Galderma 
 
 
Study # C16‐CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Week 24 
Questions 
1=Strongly 
Agree 
2 
3 
4 
5=Strongly 
Disagree 
I experienced noticeable improvement in my 
skin tone 
 
 
 
 
 
I experienced noticeable improvement in my 
skin texture 
 
 
 
 
 
I experienced noticeable improvement in my 
skin radiance 
 
 
 
 
 
My skin has a more youthful appearance 
 
 
 
 
 
My skin is clearer skin using this treatment 
 
 
 
 
 
I feel my skin is now clear 
 
 
 
 
 
This treatment is strong enough to give me 
clear, acne free skin. 
 
 
 
 
 
The treatment helped to reduce redness and 
inflammation caused by my acne. 
 
 
 
 
 
This treatment visually minimized my pore 
size. 
 
 
 
 
 
I noticed an improvement in my acne. 
Strongly agree to Strongly disagree 
 
 
 
 
 
This treatment reduces my acne without 
leaving behind dry, flakey skin. 
 
 
 
 
 
I have noticed I had fewer breakouts than 
my previous treatments.                                       
 
 
 
 
 
My skin looks better than before 
 
 
 
 
 
This treatment breaks my cycle of acne and 
keeps my skin clear                                                
 
 
 
 
 
I saw improvement in the overall health of 
my skin since starting the regimen     
 
 
 
 
 
The areas of my skin where I used to have 
acne is now clear and radiant after daily 
treatment.                                                                
 
 
 
 
 
I feel better about my skin  since I’ve started 
the treatment regimen 
 
 
 
 
 
 
 
 
_________________________________ 
Subject Initials and Date 
 
 
 


 
 
 
 
AMENDED QUESTIONNAIRES 24MAY2016 
Source Documents 
 
Galderma 
 
 
Study # C16‐CD020 
 
 
INVESTIGTOR NAME 
To be added per site 
Subject Initials  
 
 
 
 
Subject Number 
 
 
 
 
Week 24 (cont.) 
Questions 
1=Strongly 
Agree 
2 
3 
4 
5=Strongly 
Disagree 
I feel more confident since I’ve started the 
treatment 
 
 
 
 
 
Has your quality of life improved now that 
you have started using this product? 
 
 
 
 
 
I would continue using this treatment 
beyond 24 weeks as a regular part of my 
skincare routine. 
 
 
 
 
 
What is your overall satisfaction with the 
regimen? 
 
 
 
 
 
I have noticed a positive difference in the 
appearance of my skin with this regimen. 
 
 
 
 
 
I would recommend this product to others. 
 
 
 
 
 
My acne is as clear as if I went to a doctor or 
received a prescription. 
 
 
 
 
 
I don’t feel the need for a prescription after 
using this product. 
 
 
 
 
 
Do you feel this treatment is designed for 
you? 
 
 
 
 
 
Do you feel more positive and less 
frustrated about your acne and your skin 
since starting this treatment? 
 
 
 
 
 
Do you feel this treatment meets the needs 
of your skin? 
 
 
 
 
 
 
 
 
_________________________________ 
Subject Initials and Date 
 


Thomas J. Stephens Associates, Inc.
SOP-CLN-902-F055
Study Number:C16-CD020
Sponsor Study Number: GLI.04.SPR.US10354
USAGE INSTRUCTIONS:
Date
Day
Cleanser ()
Application Time
Moisturizer ()
SPF ()
Comments
5/6/2016  
Visit 1 
Friday
5/7/2016
Saturday
5/8/2016
Sunday
5/9/2016
Monday
5/10/2016
Tuesday
5/11/2016
Wednesday
5/12/2016
Thursday
5/13/2016
Visit 2
Friday
5/14/2016
Saturday
5/15/2016
Sunday
5/16/2016
Monday
5/17/2016
Tuesday
5/18/2016
Wednesday
5/19/2016
Thursday
5/20/2016
Visit 3
Friday
● Facial Moisturizer SPF 30: Apply lilberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours.
● Moisturizing Lotion: After applying the product, use moisturizer on the entire face. Apply daily to dry skin as needed or as directed by physician.
Subject Initials: __ __ __
Subject Number:__ __ __ 
Sample Diary  1
Please record daily (in BLACK INK)  the time you applied the product. DO NOT use pencil or white out, or draw arrows ↓  or quotation marks (" ").  If you have any problems, please contact Miguel at  (972) 852-5880 immediately!
●Dispense a nickel size amount of product and apply as a thin layer to the enƟre face or any other aﬀected areas of the skin once daily, aŌer washing gently with a mild soap-less cleanser and drying the area.
● Facial cleanser: Massage a small amount onto wet skin. Rinse


Thomas J. Stephens Associates, Inc.
SOP-CLN-902-F055
Study Number:C16-CD020
Sponsor Study Number: GLI.04.SPR.US10354
Subject Number:__ __ __
USAGE INSTRUCTIONS:
1
2
3
5/6/2016  
Visit 1 
Friday
5/7/2016
Saturday
5/8/2016
Sunday
5/9/2016
Monday
5/10/2016
Tuesday
5/11/2016
Wednesday
5/12/2016
Thursday
5/13/2016
Visit 2
Friday
5/14/2016
Saturday
5/15/2016
Sunday
5/16/2016
Monday
5/17/2016
Tuesday
5/18/2016
Wednesday
5/19/2016
Thursday
5/20/2016
Visit 3
Friday
● Moisturizing Lotion: After applying the product, use moisturizer on the entire face. Apply daily to dry skin as needed or as directed by physician.
● Facial Moisturizer SPF 30: Apply lilberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours.
Comments
Application Time
Moisturizer ()
SPF ()
Day
Cleanser ()
Subject Initials: __ __ __
Sample Diary 2 
Please record daily (in BLACK INK)  the time you applied the product. DO NOT use pencil or white out, or draw arrows ↓  or quotation marks (" ").  If you have any problems, please contact Miguel at (972) 852-5880  immediately!
● Facial cleanser: Massage a small amount onto wet skin. Rinse
● Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or 
three daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Date

Prot_000.pdf: 








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Page 5 of 44 
 
TITLE PAGE 
 
 
 
Title: 
A Multi-Center Clinical Trial to Evaluate the Efficacy of Two 
Acne Treatments 
Short Title: 
A Multi-Center Clinical Trial to Evaluate the Efficacy of Two 
Acne Treatments 
Protocol number: 
GLI.04.SPR.US10354 
Study phase: 
Phase IV 
Sponsor: 
Galderma Laboratories, L.P. 
14501 North Freeway 
Fort Worth, TX 76177 
USA 
Telephone: 1-817-961-5000 
 
This study will be performed in compliance with applicable federal regulations and Good Clinical 
Practice (GCP). This Clinical Study Protocol follows guidelines outlined by the International 
Conference on Harmonization (ICH) and Galderma Laboratories, L.P. (GLLP). 
All the data provided to the investigator and his/her staff and all data obtained through this GLLP 
protocol will be regarded as confidential and proprietary in nature and should not be disclosed to 
any third party without GLLP’s written consent. 
 
Effective Date:   
11 February 2016  
 
 
 
 
 


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1. 
SYNOPSIS 
Title: A Multi-Center Clinical Trial to Evaluate the Efficacy of Two Acne Treatments 
Protocol Number: GLI.04.SPR.US10354 
Study Period (Planned): Duration of subject participation is approximately 24 weeks 
(Screening/Baseline, Week 1, Week 2, Week 6, Week 12, Week 18, and Week 24) 
Phase of Development: Phase IV 
Objectives: 
 
To characterize the effectiveness of the acne treatment in lesion count at week 1, week 
2, week 6, week 12, and week 24 as compared to baseline and compare between 
treatments 
 
To characterize the effectiveness of the acne treatment in Investigator’s Global 
Improvement Assessment at week 1, week 2, week 6, week 12, and week 24 as 
compared to baseline and compare between treatments 
 
To characterize the effect of the acne treatment in clinical grading of efficacy 
parameters through digital images at week 6, week 12, and week 24 as compared to 
baseline and compare between treatments 
 
To characterize the effect of the acne treatment in subject self-assessment 
questionnaire responses at week 1, week 2, week 6, week 12, and week 24 as 
compared to baseline and compare between treatments 
Overall Study Design: 
This is a multicenter, double-blind, randomized, controlled clinical trial to be conducted in the 
United States at 4 testing facilities. The study will examine the effect of 2 acne treatments 
(Product A when used once daily and Product B when used 1-3x a day) for 24 weeks in adult 
men and women 21 to 45 years of age with mild to moderate facial acne, with at least 5 
inflammatory lesions, and 10 – 100 non-inflammatory lesions at enrollment. Subjects meeting 
the inclusion/exclusion criteria are to be enrolled in the study. There will be up to 8  visits 
during the course of the study: Screening, Baseline, Week 1, Week 2, Week 6, Week 12, 
Week 18, and Week 24.  
Number of Subjects Planned/Analyzed: Approximately 130 subjects will be enrolled to 
complete with 100 subjects (50 per cell). For the purposes of this protocol, enrolled is defined 
as a subject who has been consented, screened and eligibility has been verified. 
 
Each site is to enroll no more than 40 subjects, with at least 100 subjects expected to 
complete when combined.  


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Main Inclusion Criteria: Men and women, 21 to 45 years of age with mild to moderate facial 
acne, at least 5 inflammatory lesions, and at least 10 – 100 non-inflammatory lesions.  


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Galderma Study Products: 
Study product:  Facial Cleanser   
Form: Gel   
Instructions for Use: massage a small amount onto wet skin. Rinse.  
Mode of Administration:  Topical 
Duration of Use: 24 Weeks  
------------------------------------------------------------------------------------------------------------------------- 
Galderma Study Products: 
Study product:  Product A   
Form: Gel   
Instructions for Use: Dispense a nickel size amount of product and apply as a thin layer to the 
entire face or any other affected areas of the skin once daily, after washing gently with a mild 
soap-less cleanser and drying the area. 
Mode of Administration:  Topical 
Duration of Use: 24 Weeks  
------------------------------------------------------------------------------------------------------------------------- 
Study product:  Product B  
Form: Gel 
Instructions for Use: Clean the skin thoroughly before applying this product. Cover the entire 
affected area with a thin layer one to three times daily. Because excessive drying of the skin may 
occur, start with one application daily, then gradually increase to two or three daily if needed or 
as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a 
day or every other day. 
Mode of Administration: Topical 
Duration of Use: 24 Weeks 
------------------------------------------------------------------------------------------------------------------------- 
Galderma Study Products: 
Study product:  Moisturizing Lotion   
Form: Lotion   
Instructions for Use: After applying the product, use moisturizer on the entire face. Apply as 
needed or as directed by a physician.  
Mode of Administration:  Topical 
Duration of Use: 24 Weeks  
 ------------------------------------------------------------------------------------------------------------------------- 
Galderma Study Products: 
Study product:  Facial Moisturizer SPF 30   
Form: Cream   
Instructions for Use: Apply liberally 15 minutes before sun exposure.  Use a water resistant 
sunscreen if swimming or sweating. Reapply at least every 2 hours 
Mode of Administration:  Topical 
Duration of Use: 24 Weeks   


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Criteria for Evaluation:  
All subjects who are enrolled and receive study products will be evaluable for safety analyses. 
All subjects who are enrolled, receive study products, and have at least one post treatment 
administration evaluation will be evaluable for intent-to-treat analyses. 
General instructions: 
Use all products as directed. Cleanser, test material, and moisturizer should be used as a 
regimen. 
Avoid extended periods of sun exposure, all use of tanning beds, and sunless tanning 
products for the duration of the study. Extra care should be taken to wear protective clothing, 
including sunglasses, and avoid sun exposure from 10 AM to 4 PM.  
Continue use of all regular brands of color cosmetics, makeup remover, and use the assigned 
test material for the duration of the study.  Individuals must refrain from using any acne 
products and beginning the use of any new facial products other than the assigned test 
material. Use of moisturizing foundation will be acceptable as long as the subject has a history 
of safe usage of the foundation. 
 


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Assessment 
Measure 
 
Lesion count 
Investigator or designee will count the inflammatory 
and non-inflammatory lesions on each subject’s face 
 
Investigator’s Global 
Assessment (IGA) 
Investigator or designee will assess acne severity on 
each subject’s face using FDA’s Investigator’s 
Global Assessment scale on acne severity 
Clinical 
Grading 
of 
Efficacy 
Parameters via digital images (will be 
performed 
by 
Stephens 
expert 
graders at the end of the study): 
 
Skin texture 
 
Skin tone evenness 
 
Clarity 
 
Overall skin complexion 
Investigator or designee will assess efficacy through 
digital images using a modified Griffith’s 10-point 
scale  
Clinical 
Grading 
of 
Tolerance 
Parameters: 
 
Erythema 
 
Dryness 
 
Scaling 
 
Stinging/Burning 
Investigator or designee will assess tolerance using 
a 4-point scale. 
 
Self-Assessment 
Questionnaires  
6 to 25 item questionnaire 
 
Digital Images 
Digital photography using VISIA on the left, right, and 
center views under standard lightings: 1, 2, cross-
polarized, 
parallel 
polarized, 
UV-fluorescence 
lighting.  
 
Beauty shots (no head band/headrest/chinrest) will 
also be taken of the center view under visible light 
(Site 1 and 2 only) 
 
Safety  
Number of adverse events 
 
 


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1.1 
Study Schematic 
 
 
 
Baseline
•Enroll ~130 to complete 100, 
•assessment/dispensation of study 
products
Week 1, Week 
2, Week 6, 
Week 12
•Subject returns to testing facility for follow up
•Follow up phone calls will be made between Week 2 
and Week 6 or Week 6 and Week 12
Week 18
•Subject returns to 
testing facility for test 
material distribution and 
compliance check
Week 24
•Exit or Early Exit Visit 
and Subject returns 
product
Screening
Review 
subject 
eligibility


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TABLE OF CONTENTS 
TITLE PAGE ........................................................................................................................................... 5 
1. 
Synopsis ........................................................................................................................................... 6 
1.1 
Study Schematic ....................................................................................................................... 11 
Table of contents ..................................................................................................................................... 12 
2. 
Backround and Rationale .................................................................................................................. 15 
3. 
Study Objectives and hypothesis ........................................................................................................ 15 
3.1.1. 
Overall Purpose ................................................................................................................ 15 
3.1.2. 
Hypothesis ....................................................................................................................... 15 
4. 
SELECTION AND DISPOSITION OF STUDY POPULATION ........................................................... 15 
4.1 
INCLUSION CRITERIA ........................................................................................................... 15 
4.2 
EXCLUSION CRITERIA .......................................................................................................... 16 
4.3 
CONCOMITANT THERAPIES ................................................................................................. 17 
4.3.1. 
Authorized Therapies ........................................................................................................ 17 
4.3.2. 
Prohibited Therapies .......................................................................................................... 17 
5. 
STUDY PROCEDURES .................................................................................................................. 17 
5.1 
Protocol Waivers/Exemptions .................................................................................................... 17 
5.2 
Informed Consent Procedures ..................................................................................................... 18 
5.3 
Screening Procedures ................................................................................................................ 18 
5.3.1. 
Demographics .................................................................................................................. 18 
5.3.2. 
Medical History ................................................................................................................ 19 
5.3.3. 
Medication and Non-Drug Treatment History ....................................................................... 19 
5.3.4. 
Screen Failures ................................................................................................................. 20 
5.3.5. 
Visit Windows .................................................................................................................. 20 
5.3.6. 
Adverse Weather Provision ................................................................................................ 20 
5.4 
Visits and Examinations ............................................................................................................ 20 
5.4.1. 
Screening (up to 14 days prior to baseline or may be combined) .............................................. 20 
5.4.2. 
Baseline (Screening and Baseline may be combined) ..................................................... 21 
5.4.3. 
Week 1 ± 2 days from Baseline Visit and Week 2 ± 2 days from Baseline Visit ................ 21 
5.4.4. 
Week 6 ± 3 days from Baseline Visit and Week 12 ± 3 days from Baseline Visit .............. 22 
5.4.5. 
Week 18 ± 3 days from Baseline Visit ............................................................................. 22 
5.4.6. 
Week 24/Early Exit ± 3 days from Baseline Visit ............................................................. 22 
5.4.7. 
Unscheduled Visits............................................................................................................ 23 
5.4.8. 
Non-Clinic Days ............................................................................................................... 23 
5.5 
DISCONTINUED SUBJECTS ................................................................................................... 24 
5.6 
STUDY DURATION AND TERMINATION .............................................................................. 24 
6. 
TREATMENT ADMINISTERED ..................................................................................................... 24 
6.1 
PRODUCT IDENTIFICATION AND USE .................................................................................. 24 
6.2 
ACCOUNTABILITY ................................................................................................................ 26 


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6.3 
METHOD OF TREATMENT ASSIGNMENT ............................................................................. 27 
7. 
ADVERSE EVENTS ....................................................................................................................... 27 
7.1 
DEFINITIONS ......................................................................................................................... 27 
7.1.1. 
Adverse Events (AE) ......................................................................................................... 27 
7.1.2. 
Suspected Adverse Reaction (SAR) ..................................................................................... 28 
7.1.3. 
Serious Adverse Events (SAE) ............................................................................................ 28 
7.1.4. 
Severity ........................................................................................................................... 28 
7.1.5. 
Relationship to Study Products............................................................................................ 28 
7.1.6. 
Causality assessment ......................................................................................................... 29 
7.2 
REPORTING PROCEDURES ................................................................................................... 29 
7.2.1. 
Procedures for Reporting Adverse Events ............................................................................. 29 
7.2.2. 
Procedure for Reporting a Serious Adverse Event .................................................................. 29 
8. 
STATISTICAL METHODS PLANNED ............................................................................................ 30 
8.1 
STATISTICAL AND ANALYTICAL PLANS ............................................................................. 30 
8.1.1. 
Variables to be analyzed .................................................................................................... 30 
8.1.2. 
Populations Analyzed, Evaluability and Limitation / Evaluation of Bias ................................... 31 
8.1.3. 
Data Presentation and Graphics ........................................................................................... 31 
8.2 
SAMPLE SIZE DETERMINATION ........................................................................................... 31 
9. 
STUDY CONDUCT CONDISERATIONS ......................................................................................... 31 
9.1 
CLINICAL MONITORING ....................................................................................................... 31 
9.2 
QUALITY ASSURANCE / AUDIT / INSPECTION ..................................................................... 32 
9.3 
RECORD RETENTION ............................................................................................................ 32 
9.4 
CHANGES IN STUDY CONDUCT / AMENDMENTS ................................................................ 33 
10. 
ETHICS ......................................................................................................................................... 33 
11. 
Study flow chart .............................................................................................................................. 34 
11.1 
Study flow chart ....................................................................................................................... 34 
12. 
REFERENCES ............................................................................................................................... 35 
13. 
ATTACHMENTS ........................................................................................................................... 35 
13.1 
ELEMENTS OF INFORMED CONSENT ................................................................................... 35 
Additional Elements of Informed Consent ............................................................................................... 36 
13.2 
Assessment Scales and Descriptions ............................................................................................ 37 
13.2.1. 
Lesion Count .................................................................................................................... 37 
13.2.2. 
Investigator’s Global Assessment (IGA) ............................................................................... 37 
13.2.3. 
Clinical Grading of Efficacy Parameters through digital images ............................................... 37 
13.2.4. 
Clinical Grading of Tolerability Parameters .......................................................................... 38 
13.2.5. 
Digital images .................................................................................................................. 39 
13.2.6. 
Self-Assessment Questionnaires .......................................................................................... 39 
Appendix I: Fitzpatrick Skin Type ........................................................................................................... 44 
 


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LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
AE  
Adverse Event 
CRF 
Case Report Form 
eCRF 
Electronic Case Report Form 
etc. 
et cetera 
e.g.  
for example (Latin; exempla gratia) 
FDA 
The Food and Drug Administration 
GCP 
Good Clinical Practice 
GLLP 
Galderma Laboratories, L.P. 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
ICH 
International Conference on Harmonization  
IEC 
Independent Ethics Committee 
IPL 
Intesnse Pulse Light 
IRB 
Institutional Review Board 
LOCF 
Last Observation Carried Forward 
N or n 
Number 
OTC 
Over-the-Counter 
% 
Percent 
P  
Probability (as in significance level) 
Rx 
Prescription 
SAE 
Serious Adverse Event 
SAP 
Statistical Analyses Plan 
SD 
Standard deviation 
SOP 
Standard Operating Procedure 
i.e.  
that is (Latin:  id est) 
USV 
Unscheduled Visit 
 
 


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2. 
BACKROUND AND RATIONALE 
Acne is an inflammatory disease of the sebaceous gland that occurs during adolescence and 
persists into adulthood. Non-inflammatory acne lesions form when the opening of the follicle 
becomes blocked by the presence of dense keratin and sebum. Inflammatory acne lesions 
develop when the orifice of the follicle becomes completely occluded and bacteria replicate and 
excrete substances that induce an inflammatory reaction.  
Treatment with acne medications has been shown to help dissolve keratin plugs and help prevent 
the proliferation of bacteria in the sebaceous gland. This results in a reduction in the numbers of 
non-inflammatory and inflammatory acne lesions.1,2 
 
3. 
STUDY OBJECTIVES AND HYPOTHESIS 
3.1.1. Overall Purpose 
The purpose of this study is to evaluate the efficacy of 2 acne treatments for 24 weeks 
of use in adult men and women with mild to moderate facial acne, at least 5 
inflammatory lesions, and at least 10 – 100 non-inflammatory lesions.  
 
3.1.2. Hypothesis 
    After 24 weeks of 1 to 3 times per day use:  
 
Subjects will demonstrate an improvement in acne lesion counts (inflammatory and 
non-inflammatory) as assessed by a trained grader when compared to baseline. 
 
Subjects will demonstrate an improvement in global assessment (IGA) as assessed 
by a trained grader over the course of the study, when compared to baseline. 
 
Subjects will demonstrate an improvement in facial skin condition as assessed by 
a trained grader, through digital images, when compared to baseline. 
 
Subjects will report high satisfaction with the acne treatment as measured through 
self-assessment questionnaires. 
 
4. 
SELECTION AND DISPOSITION OF STUDY POPULATION 
4.1 
INCLUSION CRITERIA  
1. Men and women age 21 to 45  years at the time of enrollment. 
2. Individuals with mild to moderate acne (score of 2-3 on FDA Investigator’s Global 
Assessment Scale1) on the face. 
3. Individuals with at least 5 inflammatory lesions. 
4. Individuals with 10 – 100 non-inflammatory lesions. 
5. Individuals willing to use the test products as instructed for 24 weeks.  
6. Fitzpatrick skin type I-VI (refer to Appendix I: Fitzpatrick Skin Type). 
7. Individuals willing and able to comply with all of the time commitments and procedural 
requirements of the clinical trial protocol. 
8. Individuals willing to provide written informed consent including photo release, Health 
Insurance Portability and Accountability Act (HIPAA), and are able to read, speak, 
write, understand English and are willing to share personal information and data, as 
verified by signing a written authorization at the screening. 
9. Willing to withhold all facial treatments during the course of the study including 
botulinum toxin, injectable fillers, microdermabrasion, IPL, peels, facials, laser 
treatments and tightening treatments.  Waxing and threading is allowed but not facial 


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laser hair removal. 
10. Males who are regular shavers and willing to shave on the day of the study visits (prior 
to clinic visits). 
 
11. Women of child bearing potential who are willing to take a urine pregnancy test prior 
to study enrollment, at week 24, and when deemed appropriate by the Investigator 
and/or Sponsor. 
12. Individuals of child bearing potential who use an acceptable method of contraception 
throughout the study.  Acceptable methods of birth control include: 
 
 
Oral and other system contraceptives. Individuals must be on a stable use for 
3 months prior to study enrollment. Individuals on oral contraceptives must not 
alter their use, including dose or regimen for the duration of the study 
 
Double barrier 
 
Bilateral tubal ligation 
 
Partner vasectomy 
 
Abstinence 
13. Individuals willing to follow study requirements and report any changes in health status 
or medications, adverse event symptoms, or reactions immediately. 
14. Subjects must be stable on any medication they are taking for at least 30 days  
 
4.2 
EXCLUSION CRITERIA  
1. Individuals diagnosed with allergies to topical acne products. 
2. Individuals having a condition and/or disease of the skin that the Investigator deems 
inappropriate for participation. 
3. Women who are nursing, pregnant, or planning to become pregnant during the study. 
4. Individuals who have pre-existing or dormant dermatologic conditions on the face 
(e.g., psoriasis, rosacea, eczema, seborrheic dermatitis, severe excoriations etc.) 
which in the opinion of the Investigator could interfere with the outcome of the study. 
5. Individuals with a history of immunosuppression/immune deficiency disorders 
(including (HIV infection or AIDS) or currently using immunosuppressive medications 
(e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, 
mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.).  
6. Individuals with an uncontrolled disease such as asthma, diabetes, hypertension, 
hyperthyroidism, or hypothyroidism. Individuals having multiple health conditions may 
be excluded from participation even if  the conditions are controlled by diet, medication, 
etc. at the Investigator’s discretion. 
7. Individuals who are currently participating in another facial usage study or have 
participated in a clinical trial within 4 weeks prior to inclusion into the study. 
8. Individuals with a history of skin cancer on the face within the past 5 years. 
9. Individuals with any planned surgeries and/or invasive medical procedures during the 
course of the study. 
10. Individuals who started hormone replacement therapies (HRT) or hormones for birth 
control less than 3 months prior to study entry or who plan on starting, stopping, or 
changing doses of HRT or hormones for birth control during the study. 
11. Individuals with facial sunburn or excessive tanned facial skin or that are not willing to 
avoid daily sun exposure on the face and the use of tanning beds or sunless tanning 
products for the duration of the study. 
12. Individuals with severe acne, acne conglobata, multiple nodules or cysts (more than 
2). 


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13. Individuals currently taking a natural or prescription testosterone blocker (e.g. saw 
palmetto, blask cohosh, chaste tree, chasteberry, spironolactone, drospirenone, 
progestins). 
14. Individuals currently on a testosterone booster or prescription testosterone (e.g. 
DHEA, tribulus, testosterone cypionate, testosterone enanthate, Sustanon, 
testosterone propionate, testosterone phenylpropriate, Omnadren etc.). 
15. Individuals that are currently taking or have taken within the last 30 days oral or topical 
prescription medications for acne such as Doxycycline, Minocycline, Clindamycin, 
Bactrim, Tetracycline, Erythromycin, Vibramycin and topical tretinoin.(Retin A Renova, 
Adapalene, Tazarotene), Azelaic acid, benzoyl peroxide, Dapsone, Sodium 
sulfacetamide, Differin, Epiduo. 
16. Individuals that have used oral isotretinoin (Accutane) within the past 6-months. 
17. Individuals routinely using (3x a week or more) topical OTC acne product (e.g. benzoyl 
peroxide, salicylic acid, alpha hydroxyl, beta hydroxyl and/or poly-hydroxy products or 
medicated cleansers, wipes, masks, scrubs, gels and creams) within 14 days of the 
study entry. 
18. Individuals using or who have used any systemic medication considered to affect the 
course of acne, specifically, but not exclusively antibiotics or steroids within the last 30 
days prior to entry into the study. 
19. Individuals with excessive facial hair, including beard, mustache or goatee, or scars, 
which could interfere with evaluations by Investigator or designee. 
 
4.3 
CONCOMITANT THERAPIES 
4.3.1. Authorized Therapies 
Product A used once daily or Product B used 1 to 3 times daily in AM/PM are required for this 
study. Subject Product Kit will include: study drug, cleanser, moisturizing lotion, and moisturizer 
SPF. 
Unless listed under the exclusion criteria (Section 4.2) or in Prohibited Therapies (Section 4.3.2), 
other therapies to treat ongoing conditions are authorized. 
 
4.3.2. Prohibited Therapies 
The prohibited treatments are provided in the exclusion criteria in section 4.2. 
The decision to administer a prohibited medication/treatment should be made with the safety of 
the subject being the primary consideration. Whenever possible, GLLP should be notified before 
the prohibited medication/treatment is administered to discuss possible alternatives. 
If a subject receives prohibited therapy during the study, the subject may be allowed (at the 
discretion of the investigator / GLLP) to continue in the study for safety evaluation purposes, only.  
Galderma must be immediately notified in all instances of administration of prohibited meds.  
 
5. 
STUDY PROCEDURES 
5.1 
Protocol Waivers/Exemptions 
Neither ICH nor the Food and Drug Administration (FDA) have defined the terms ‘Protocol 
Violations’ and ‘Protocol Deviations’. No “waivers” or “approvals” will be granted for protocol 
deviations or inclusion/exclusion criteria violations. 
Sites are instructed to report protocol deviations to Stephens and Associates which will report the 
deviations to the Independent Ethics Committee/Institutional Review Board (IEC/IRB) per their 


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IEC/IRB’s guidelines.  
Protocol non-compliance including lost to follow-up subjects should be reported to the site monitor 
as well as study management as soon as it is identified.  
5.2 
Informed Consent Procedures 
An IEC/IRB approved informed consent template containing the required elements of an informed 
consent will be reviewed and approved by GLLP. Any changes made to these templates must be 
approved by GLLP prior to submission to the IEC/IRB for site approval. After approval by GLLP, 
the informed consent form must be submitted to and approved by the IEC/IRB.  
It is the responsibility of the investigator to inform each subject, prior to the screening evaluation, 
of the purpose of the study, including possible risks and benefits, and to document the informed 
consent process in the subject’s research chart (and medical record, if applicable). Prior to entry 
into the study or initiation of any study related procedures, the subject must read, sign, and date 
the current IEC/IRB approved version of the consent form in accordance with local legal 
requirements and IEC/IRB requirements. The original informed consent form is to be retained at 
the study site, and a copy is to be given to the subject. 
 
5.3 
Screening Procedures 
Screening will not be allowed at the site until the site has obtained all applicable IEC/IRB 
approvals and a fully executed Clinical Study Agreement (CSA). The sponsor will notify the site 
once screening may begin. 
Subjects must be consented using the IEC/IRB approved informed consent(s) prior to all study 
assessments and discontinuation of medication(s). Date and time of consent, as well as a 
summary of the consent discussion should be documented in the source. 
 
Each screened subject will be assigned a unique subject number.  The subject numbers will be 
assigned by site, with the first digit will be used to indicate which site the subject was enrolled at 
and with an additional 2 numbers at the end being the subject number (3 digits total). 
 
Site 1 (Stephens Texas) examples: 101, 102, 103, etc.   
 
Site 2 (Stephens Colorado) examples: 201, 202, 203, etc. 
 
Site 3 (Austin Institute for Clinical Research, Inc.) examples: 301, 302, 303, etc. 
 
Site 4 (RCTS, Inc.) examples: 401, 402, 403, etc. 
 
5.3.1. Demographics 
The following demographic parameters will be captured at the screening visit: 
 
Age 
 
Gender  
 
Ethnicity and Race (subject self-identified) 
 
Fitzpatrick Skin Type Classification 
 


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5.3.2. Medical History 
The investigator or designee should complete a thorough review of the subject’s medical history 
for missing information. Medical conditions obtained at screening prior to enrollment should be 
captured and recorded in the subject’s baseline medical history. All relevant “lifetime” medical 
conditions are to be included.  Items to include are: 
 
All ongoing medical diseases/condition, including chronic, intermittent, or recurrent 
disease. 
 
Any condition that requires ongoing therapy. 
 
All disease/conditions resolved in the past 30 days. 
 
Any condition that, in the opinion of the investigator, is clinically relevant including 
diseases for which the subject required surgery. 
 
Subjects with conditions that, in the opinion of the investigator, may put the subject at risk, 
may confound study results, or may interfere with participation in the study must be 
excluded from the study. 
        Contact GLLP Medical Lead if further clarifications are needed. 
Name/Title 
Affiliation/Tel./Fax 
Marie-Jose Rueda, MD 
Rx Medical Director 
 
Galderma Laboratories, L.P. 
Tel : (817) 961-5227 
5.3.3. Medication and Non-Drug Treatment History 
Previous drug and non-drug therapies should be assessed as related to the eligibility criteria listed 
in the protocol. Information on previous therapies (including herbal products) that have been 
stopped within 6 months prior to visit screening should be recorded on the CRF.  
Other medications to treat concurrent medical conditions ARE permitted provided the 
dose is stable for at least 30 days prior to screening and throughout the study. 
Any therapy used by the subject during the study will be considered a concomitant 
medication/non-drug treatment. Concomitant medications and non-drug treatments obtained at 
screening and baseline prior to enrollment should be captured and recorded in the subject’s 
baseline medication and non-drug treatment history. Every attempt should be made to keep all 
concomitant medication/therapy dosing and regimens constant during the study. Any change to 
this therapy should be noted on the CRFs. If applicable, an Adverse Event CRF/eCRF should be 
completed for any subject starting new concomitant medications, unless the therapy is used for 
prophylaxis.  
Concomitant medications and non-drug therapies during the course of the study are defined as: 
Any new therapy received by the subject after subject enrollment, including: 
– 
Drug therapies, such as Rx medications, OTC products (excluding OTC personal 
hygiene products), birth control medication, homeopathic preparations, vitamins, 
sunscreens, etc. 
**Fitzpatrick Skin Type Classification (Please  select one): 
  I –   Always burns; never tans 
  II –  Burns easily; tans minimally 
  III – Burns moderately; tans gradually to light brown 
  IV – Burns minimally; tans well to moderate brown 
  V –  Rarely burns; tans profusely to dark brown 
  VI – Never burns; tans profusely to black 


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– 
Non-drug therapies, such as medical/surgical procedures. 
– 
Any changes to existing therapies, such as changes in dose or formulation. 
The concomitant therapies are to be recorded at each visit on the appropriate CRF/eCRF. 
 
5.3.4. Screen Failures 
If a consented subject fails to meet all of the requirements to participate in the study, or decides 
not to participate up to the point of enrollment at visit 1 (baseline), the subject will be considered 
a screen failure. The reason for screen failure should be documented appropriately in the source 
document and the CRF/eCRF. 
5.3.5. Visit Windows 
Visit windows as outlined below are allowed during the study: 
 
Screening (up to 14 days prior to baseline visit) 
 
Baseline   
 
Week 1 ±2 days from Baseline Visit 
 
Week 2 ± 2 days from Baseline Visit 
 
Week 6 ± 3 days from Baseline Visit 
 
Week 12 ± 3 days from Baseline Visit 
 
Week 18 ± 3 days from Baseline Visit 
 
Week 24 ± 3 days from Baseline Visit 
5.3.6. Adverse Weather Provision 
Study visits may be delayed if adverse weather conditions present a risk to the safety of persons 
traveling to the investigative site. Visits will be resumed immediately with the earliest acceptable 
improvement of travel conditions and staff availability. GLLP will be notified of changes in 
scheduled visit dates.  
5.4 
Visits and Examinations 
5.4.1. Screening (up to 14 days prior to baseline or may be combined) 
1. Review and explain the purpose and nature of the study to the subject. 
2. Obtain Subject Informed Consent. 
 
Have the subject read, sign and date an IEC/IRB approved informed consent 
including photo and video release, HIPAA authorization, and applicable state Bill 
of Rights.  
 
Document the informed consent process in the source documents and CRF/.  
 
Give a signed copy of the informed consent form to subject. 
3. Assign the subject a unique screening number. Update screening and enrollment log. 
4. Have subjects acclimate for at least 15 minutes in ambient temperature and humidity -
conditions (68-75ºF and 35-65% humidity) 
5. Confirm subject meets inclusion/exclusion criteria including mild to moderate facial acne 
(score of 2-3 on FDA Investigator’s Global Assessment Scale), at least 5 inflammatory 
lesions, and 10 -100 non-inflammatory lesions and have this recorded by the Investigator 
or designee.  
6. Have the Investigator or designee complete the tolerance grading. 


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7. Obtain demographic information and medical history, including information on all 
medications/therapies used within the last 6 months. Inform the subject as to the allowed 
and prohibited concomitant medications (see Section 4.2 and 4.3.2). If the candidate 
subject qualifies and is female of child-bearing potential, conduct a urine pregnancy test. 
Candidate female subjects with negative results, females of non-child-bearing potential, 
or candidate males that qualify will proceed to the next step.  
8. Candidate subject’s eligibility will be overseen by a dermatologist or MD physician. The 
dermatologist will confirm that the subject is suitable for the test materials. Those that 
qualify will be asked to return for the baseline visit. 
9. Record any AEs that occur after the subject has signed the informed consent form. 
 
Note: Subject screening and baseline visits may occur on the same day if site logistics permit. 
 
5.4.2. Baseline (Screening and Baseline may be combined) 
1. Obtain information on any changes in medical health and/or the use of concomitant 
medications/therapies to ensure the subject’s eligibility in the study.  
2. Record any AEs that are observed or reported, including those of changes in concomitant 
medication dosing/therapies. 
3. Confirm subject still meet inclusion/exclusion criteria including mild to moderate facial 
acne (score of 2-3 on FDA Investigator’s Global Assessment Scale), at least 5 
inflammatory lesions, and 10 -100 non-inflammatory lesions and have this recorded by the 
Investigator or designee.  
4. Subject’s eligibility and health will be re-reviewed. Those that still pass eligibility 
requirements will be enrolled into the study and assigned a subject number.  
5. Have the Investigator or designee complete the tolerance grading. 
6. Subjects will participate in digital images procedures. 
7. Subject will be randomly assigned to receive Product A or Product B as determined by a 
randomization schedule provided by Stephens. Study products will be dispensed and 
subjects will be provided instructions on how to properly use the study products.  
8. Subjects will be provided with a daily diary to record product application. 
9. Emphasize the importance of compliance with the instructions and application 
requirements. 
10. Instruct the subject to bring back the dispensed study products at the next visit 
 
5.4.3. Week 1 ± 2 days from Baseline Visit and Week 2 ± 2 days from Baseline Visit 
1. Obtain information on any changes in medical health and/or the use of concomitant 
medications/therapies to ensure the subject’s eligibility in the study. 
2. Record any AEs that are observed or reported, including those of changes in concomitant 
medication dosing/therapies. 
3. Have the subject acclimate for at least 15 minutes in ambient temperature and humidity 
condition (68-75ºF and 35-65% humidity). 
4. Have the investigator or designee complete the lesion count (inflammatory and non-
inflammatory). 
5. Have the Investigator or designee complete the Investigator Global Assessments (IGA) 
on acne severity. 
6. Have the Investigator or designee complete the tolerance grading. 
7. Have the subject complete the self-assessment questionnaire. 
8. Emphasize the importance of compliance with the instructions and application 
requirements. 


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9. Daily diaries will be collected, reviewed for compliance of the study product application. 
The diaries will be returned to the subjects at week 1. At week 2, diaries will be retained 
by the testing facility and  new diaries will be distributed to the subjects. 
10. Collect, weigh, and re-dispense study product.  
11. Instruct the subject to bring back the dispensed study products at the next visit.   
 
5.4.4. Week 6 ± 3 days from Baseline Visit and Week 12 ± 3 days from Baseline Visit 
1. Obtain information on any changes in medical health and/or the use of concomitant 
medications/therapies to ensure the subject’s eligibility in the study. 
2. Record any AEs that are observed or reported, including those of changes in concomitant 
medication dosing/therapies. 
3. Have the subject acclimate for at least 15 minutes in ambient temperature and humidity 
condition (68-75ºF and 35-65% humidity). ‘ 
4. Have the investigator or designee complete the lesion count (inflammatory and non-
inflammatory). 
5. Have the Investigator or designee complete the Investigator Global Assessments (IGA) 
on acne severity. 
6. Have the Investigator or designee complete the tolerance grading. 
7. Have subjects participate in digital images procedures. 
8. Have the subject complete the self-assessment questionnaire. 
9. Emphasize the importance of compliance with the instructions and application 
requirements. 
10. Daily diaries will be collected, reviewed for compliance of the study product application, 
and retained by the testing facility. New diaries will be distributed to the subjects. 
11. Collect, weigh, and re-dispense study product. Products will be retained and new products 
will be dispensed as necessary. 
12. Instruct the subject to bring back the dispensed study products at the next visit.   
 
Follow-up phone calls will be made between Week 6 and Week 12 to inquire how subjects are 
progressing and if subjects have enough study product to use until the next visit. 
 
5.4.5. Week 18 ± 3 days from Baseline Visit 
1. Obtain information on any changes in medical health and/or the use of concomitant 
medications/therapies to ensure the subject’s eligibility in the study. 
2. Record any AEs that are observed or reported, including those of changes in concomitant 
medication dosing/therapies. 
3. Emphasize the importance of compliance with the instructions and application 
requirements. 
4. Daily diaries will be collected, reviewed for compliance of the study product application, 
and retained by the testing facility. New diaries will be distributed to the subjects. 
5. Collect, weigh, and re-dispense study product.  
6. Instruct the subject to bring back the dispensed study products at the next visit.   
 
5.4.6. Week 24/Early Exit ± 3 days from Baseline Visit 
1. Obtain information on any changes in medical health and/or the use of concomitant 
medications/therapies to ensure the subject’s eligibility in the study. 
2. Record any AEs that are observed or reported, including those of changes in concomitant 
medication dosing/therapies. 


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3. Conduct a urine pregnancy test on women of child-beraing potential. 
4. Have the subject acclimate for at least 15 minutes in ambient temperature and humidity 
condition (68-75ºF and 35-65% humidity).  
5. Have the investigator or designee complete the lesion count (inflammatory and non-
inflammatory). 
6. Have the Investigator or designee complete the Investigator Global Assessments (IGA) 
on acne severity. 
7. Have the Investigator or designee complete the tolerance grading. 
8. Have subjects participate in digital images procedures. 
9. Have the subject complete the self-assessment questionnaire. 
10. Daily diaries will be collected, reviewed for compliance of the study product application, 
and retained by the testing facility.  
11. Collect and weigh study product.  
12. Complete the Exit Form CRF/eCRF. 
 
After study completion, a trained grader from Stephens will evaluate the digital images taken at 
baseline, week 6, week 12, and week 24 for clinical grading of efficacy parameters. 
 
5.4.7. Unscheduled Visits 
Any visit that occurs between the regularly scheduled visits must be documented in the 
Unscheduled Visit (USV) pages of the CRF/eCRF. During all USVs, the following procedures will 
be conducted: 
1. Obtain information on any changes in medical health and/or the use of concomitant 
medications/therapies to ensure the subject’s eligibility in the study. 
2. Record any AEs that are observed or reported, including those of changes in concomitant 
medication dosing/therapies.  
3. Daily diaries will be collected and reviewed for compliance of the study product application. 
4. Have the investigator or designee complete the lesion count (inflammatory and non-
inflammatory). 
5. Have the Investigator or designee complete the Investigator Global Assessments (IGA) 
on acne severity. 
6. Have the Investigator or designee complete the tolerance grading. 
7. Have the subject acclimate for at least 15 minutes in ambient temperature and humidity 
condition. Upon acclimation, have subjects participate in digital images procedures. 
8. Have the subject complete the self-assessment questionnaire. 
9. Emphasize the importance of compliance with the instructions and application 
requirements. 
10. Collect and weigh study products. 
 
These procedures are required at USVs; however at the investigator discretion additional 
assessments may be performed and recorded on the USV CRF/eCRF.  If a subject is discontinued 
at an USV, refer to Section 5.5 for guidance.  
5.4.8. Non-Clinic Days  
Instruct subjects to use Product A once daily or Product B 1-3 times a day following the same 
instructions discussed during the clinic visit. Subjects will be instructed to cleanse their face and 
remove any make-up (if applicable) 30  minites prior to each clinic visits. 


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5.5 
DISCONTINUED SUBJECTS 
Any subject is free to discontinue his/her participation in this study at any time and for whatever 
reason, specified or unspecified, and without prejudice.   
Subjects who discontinue the study prematurely should be fully evaluated, whenever possible.  
The procedures designated for the early exit visit (Section 5.4.7) should be completed for all 
prematurely discontinued subjects and the appropriate CRFs should be completed.  
All subjects who prematurely discontinue the study should have the reason carefully documented 
by the investigator on the exit CRF/eCRF, and, if applicable, on the adverse event CRF/eCRF. In 
no case, shall a subject who prematurely discontinues (who has been included and has had a 
subject identification number assigned), be replaced by another subject. In the case of premature 
discontinuation due to an AE, the investigator should ensure that the subject receives appropriate 
follow-up and therapy for their condition. All data gathered on the subject related to AE resolution 
will be made available to the Sponsor and/or regulatory authorities. 
An investigator may decide to discontinue a subject from the study for safety reasons or when it 
is in the best interest of the subject. GLLP may also decide to prematurely terminate or suspend 
the study or the participation of a subject in the study. All data gathered on the subject prior to 
termination should be made available to GLLP. 
The Exit Form must be completed and one of the following reasons for discontinuation must be 
identified:  
 
Adverse Event 
 
Subject Request 
 
Protocol Violation 
 
Lost to Follow-up 
 
Other  
If reason for discontinuation is “other”, the subject will be questioned to definitively rule out the 
possibility of an AE. 
5.6 
STUDY DURATION AND TERMINATION 
Study duration for each subject is approximately 24 weeks. It is estimated a maximum of 10 
months will elapse between first subject first visit and last subject last visit.  
The investigator may terminate the study at his/her study site at any time with appropriate 
notification to GLLP. Likewise, GLLP may terminate prematurely the participation of a particular 
study site (e.g., for non-enrollment or non-compliance with protocol, regulation or Good Clinical 
Practice) or terminate prematurely the entire study (e.g., for safety, quality of study product, 
regulatory, efficacy or logistics reasons) at any time with appropriate notification. 
6. 
TREATMENT ADMINISTERED 
At baseline, qualified subjects will be enrolled and randomized to receive Product A or Product B. 
Throughout the study, the investigator will be responsible for the accounting of the study product 
and will ensure that the study product is not used in any unauthorized manner. 
6.1 
PRODUCT IDENTIFICATION AND USE 
Study Product: Product A  
Form 
Gel 


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Instructions for use 
Dispense a nickel size amount of product and apply as a thin layer 
to the entire face or any other affected areas of the skin once daily, 
after washing gently with a mild soap-less cleanser and drying the 
area. 
Mode of Administration: 
Topical 
Duration of Use: 
24 Weeks  
Quantity: 
1 
How supplied: 
Kit 
Storage and Handling 
Product to be stored at USP Controlled Room Temperature 
conditions: 68°F – 77°F (20°C – 25°C) with excursions permitted 
between 59°F – 86°F (15°C – 30°C) 
Study Product: Product B  
Form 
Gel 
Instructions for use 
Clean the skin thoroughly before applying this product. Cover the 
entire affected area with a thin layer one to three times daily. 
Because excessive drying of the skin may occur, start with one 
application daily, then gradually increase to two or three daily if 
needed or as directed by a doctor. If bothersome dryness or peeling 
occurs, reduce application to once a day or every other day. 
Mode of Administration: 
Topical 
Duration of Use: 
24 Weeks  
Quantity: 
2 
How supplied: 
Kit 
Storage and Handling 
Product to be stored at Room Temperature conditions: 68°F – 77°F 
(20°C – 25°C). Keep product away from excess heat and moisture. 
 
Facial Cleanser 
Form 
Gel 
Instructions for use 
Massage a small amount onto wet skin. Rinse 
Mode of Administration: 
Topical 
Duration of Use: 
24 Weeks  
Quantity: 
1 
How supplied: 
Kit 
Storage and Handling 
Fragile, handle with care. Keep from freezing and extreme heat. 
Moisturizing Lotion 
Form 
Lotion 
Instructions for use 
After applying the product, use moisturizer on the entire face. Apply 
daily to dry skin as needed or as directed by physician. 
Mode of Administration: 
Topical 
Duration of Use: 
24 Weeks  
Quantity: 
1 
How supplied: 
Kit 


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Storage and Handling 
Fragile, handle with care. Store at controlled room temperateure; 
68°F – 77°F (20°C – 25°C) with excusrsions permitted between 59°F 
-86°F (15°C – 30°C). 
Facial Moisturizer SPF 30 
Form 
Cream 
Instructions for use 
Apply lilberally 15 minutes before sun exposure. Use a water 
resistant sunscreen if swimming or sweating. Reapply at least every 
2 hours. 
Mode of Administration: 
Topical 
Duration of Use: 
24 Weeks  
Quantity: 
1 
How supplied: 
Kit 
Storage and Handling 
Fragile, handle with care. Keep from freezing and extreme heat. 
 
General instructions: 
Use all products as instructed. Cleanser, test material, and moisturizer should be used as a 
regimen. 
Avoid extended periods of sun exposure, all use of tanning beds, and sunless tanning products 
for the duration of the study. Extra care should be taken to wear protective clothing, including 
sunglasses, and avoid sun exposure from 10 AM to 4 PM.  
Continue use of all regular brands of color cosmetics, makeup remover, and use the assigned 
test material for the duration of the study.  Individuals must refrain from using any acne products 
and beginning the use of any new facial products other than the assigned test material. Use of 
moisturizing foundation and waterproof SPF will be acceptable as long as the subject has a history 
of safe usage of the foundation and waterproof SPF. 
 
Subjects will be instructed to use Product A once daily or Product B 1-3x a day.  
6.2 
ACCOUNTABILITY 
Upon receipt of the study products, the investigator or designee will conduct an inventory. In 
accordance with federal regulations, the investigator must agree to keep all study products in a 
secure location with restricted access. Designated study personnel will provide the study products 
to the subjects in accordance with the protocol. A daily temperature log will be maintained 
documenting appropriate study product storage conditions. 
During the study, the investigator must maintain records of study treatment dispensation for each 
subject. This record must be made available to the study monitor for the purposes of verifying the 
accounting of clinical supplies. Any discrepancies and/or deficiencies between the observed 
disposition and the written account must be recorded along with an explanation.  
Compliance will be assessed by study staff at each visit. Subjects will be considered compliant 
with the treatment product if they use at least 80% of the expected applications for each of the 
test product during participation in the study. Subjects will be considered non-compliant if usage 
is over 120%. 
Subjects will complete a daily diary recording test material applications and comments during 
the course of the study. Diaries will be reviewed and test materials will be visually inspected at 


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each post-baseline study visit to evaluate treatment compliance. Additionally, test material units 
will be weighed prior to distribution and at week 1, week 2, week 6, week 12, week 18, and 
week 24.  
 
If subjects do not return their diary or test materials during an interim visit, a verbal confirmation 
will be obtained for usage compliance and will be documented as a note to file. The subject will 
be reminded to return their diary and test materials at the next study visit. 
 
6.3 
METHOD OF TREATMENT ASSIGNMENT 
Prior to the start of the study, Stephens will generate a randomization list to establish treatment 
assignment to 1 of the treatment cells (Cell 1 and Cell 2), which will be balanced between sites. 
Stephens will provide the product label coding according to the provided randomization.  
 
7. 
ADVERSE EVENTS 
Throughout the course of the study, all adverse events will be monitored and reported on an 
adverse event CRF/eCRF without omitting any requested and known information. When AEs 
occur, the main concern is the safety of the study subjects. At the time of the informed consent 
signature, each subject must be given the name and phone number of study site personnel for 
reporting AEs and medical emergencies.This information is included in the Informed Consent.  
At each visit, after the subject has had the opportunity to spontaneously mention any problems, 
the investigator or designee should inquire about AEs by asking the standard questions (e.g): 
“Have you had any health problems since your last study visit?” 
“Have there been any changes in the medicines you take since your last study visit?” 
AEs should be reported as a result of an untoward (unfavorable and unintended) change from 
baseline in a subject's medical health following signature of the Informed Consent. 
Changes from baseline in any protocol-specific parameter evaluated during the study are to be 
reviewed by the investigator. In addition, the subject’s responses to any questionnaire utilized 
during the study are to be reviewed by the investigator. Any untoward (unfavorable and 
unintended) change from baseline in a protocol-specific parameter or questionnaire response is 
to be reported as an AE. These clinically relevant changes will be reported regardless of causality. 
7.1 
DEFINITIONS 
7.1.1. Adverse Events (AE) 
Adverse event means any untoward medical occurrence associated with the use of a study 
product in humans, whether or not considered study product related. 
An adverse event (also referred to as an adverse experience) can be any unfavorable and 
unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally 
associated with the use of a study product, and does not imply any judgment about causality. An 
adverse event can arise with any use of the study product (e.g., off-label use, use in combination 
with another study product) and with any route of administration, formulation, or dose, including 
an overdose. 
Thus any new sign, symptom or disease, or clinically significant increase in the intensity of an 
existing sign, or symptom should be considered as an adverse event. 
Notes: 
Any new clinically relevant sign or symptom suffered by the subject, which appears after the study 
procedures should also be reported as an adverse event. 


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7.1.2. Suspected Adverse Reaction (SAR) 
Suspected adverse reaction means any adverse event for which there is a reasonable possibility 
that the study product caused the adverse event. ‘Reasonable possibility’ means there is evidence 
to suggest a causal relationship between the study product and the adverse event.  
Any adverse event, whether or not it is related to the study product, will be reported on the AE 
CRF along with the date of onset, the severity, the relationship with the study product and the 
outcome. 
If the subject discontinues due to an AE, the AE CRF and exit CRF must be completed. 
7.1.3. Serious Adverse Events (SAE) 
An adverse event or suspected adverse reaction is considered “serious” if in a view of either the 
investigator or sponsor, it results in any of the following outcomes:  
 
death, 
 
life-threatening adverse event (the event places the subject at immediate risk of death), 
 
inpatient hospitalization or prolongation of existing hospitalization, 
 
a persistent or significant disability/incapacity or substantial disruption of the ability to 
conduct normal life functions, or 
 
a congenital anomaly/birth defect 
 
Additionally: 
Important medical events that are based on appropriate medical judgment may jeopardize the 
subject and may require medical or surgical intervention to prevent one of the outcomes listed 
above. 
Note:  The term “life-threatening” refers to an adverse event or suspected adverse reaction if, in 
the view of either the investigator or sponsor, its occurrence places the subject at immediate risk 
of death. It does not include an adverse event or suspected adverse reaction that, had it occurred 
in a more severe form, might have caused death.  
Hospitalization solely for the purpose of diagnostic tests, even if related to an AE, elective 
hospitalization for an intervention which was already planned before the inclusion of the subject 
in the study, and admission to a day-care facility may not themselves constitute sufficient grounds 
to be considered as a serious adverse event. Hospitalization is defined as admission to a hospital 
for greater than 24 hours. 
7.1.4. Severity 
Severity is a clinical determination of the intensity of an adverse event. 
The severity assessment for an AE is to be completed using the following definitions as a guideline 
for all AEs occurring during clinical trials conducted or sponsored by Galderma, Laboratories, 
L.P.: 
Mild: 
 
Awareness of sign or symptom, but easily tolerated 
Moderate: 
Discomfort, enough to cause interference with usual activity 
Severe: 
Incapacitating with inability to work or perform usual activity 
 
7.1.5. Relationship to Study Products 
The relationship assessment for an AE is to be completed using the following definitions as a 
guideline for all AEs occurring during clinical trials conducted or sponsored by Galderma 
Laboratories, L.P.: 


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7.1.6. Causality assessment 
The Investigator is to determine whether there is a reasonable causal relationship between the 
trial/test products(s) and/or procedures and the event. Medical judgment should be used to 
determine the relationship, considering all relevant factors including the pattern of event, temporal 
relationships, positive de-challenge or re-challenge, relevant medical history, and confounding 
factors such as co-medication or concurrent diseases. 
 
The relationship assessment for an event is to be completed using the following definitions: 
 
Reasonable possibility: According to the reporting Investigator, there is a reasonable 
possibility (i.e., suggestive evidence or arguments) that there is a causal relationship 
irrespective of the dose administered between the trial/test product and/or procedures and 
the event, 
 
No Reasonable Possibility: No suggestive evidence or arguments can be identified 
regarding a causal relationship between the trial/test product and/or procedures and the 
event. 
The expression “reasonable causal relationship” is meant to convey in general that there are facts 
or arguments to suggest a causal relationship. 
 
Assessment of casualty must be completed by the investigator.  
 
7.2 
REPORTING PROCEDURES 
7.2.1. Procedures for Reporting Adverse Events 
The collection of AEs will begin when a subject signs the informed consent up to the final visit. At 
each visit, the investigator or designee will question the subject about AEs using questions taking 
care not to influence the subject’s answer (e.g. “Have you noticed any change in your health?”). 
Directed questioning and examination will then be done when appropriate.  
Any AE, whether or not it is related to the study product, will be reported on the AE CRF/eCRF 
along with the date of onset, the severity, the relationship with the study product and the outcome 
without omitting any requested and known information. Additional information may be requested 
under certain circumstances to ensure accurate reporting. 
Every time a concomitant medications/therapy is administered or prescribed during the study, an 
AE CRF/eCRF will be completed if appropriate and the reason for the treatment noted. 
When an AE persists after a subject exits the study, the investigator will ensure an appropriate 
follow-up of the subject until the investigator/GLLP agrees the event is satisfactorily resolved or 
has reached a stable clinical endpoint. 
 
Sites 2, 3, and 4 will report AEs to Site 1 by e-mail to areaka@stephens-associates.com. Site 1 
will report AEs to GLLP. 
 
7.2.2. Procedure for Reporting a Serious Adverse Event  
For any SAE, occurring during the study, whether or not related to the study product, expected or 
not, the investigator is to take the following steps: 
1. Take prompt and appropriate medical action, if necessary. The safety of study subjects is 
the first priority.  
2. Inform 
GLLP 
of 
the 
event 
by 
fax 
(682-831-9197) 
and 
email 
at 
pharmacovigilanceUS@galderma.com within 24 hours, and discuss further steps to be 
taken. Galderma representatives and their contact information are provided in the 


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communication plan that accompanies this protocol. Also inform Stephens & Associates 
by e-mail at areaka@stephens-associates.com, the same as GLLP. 
3. Complete the AE CRF/eCRF with as much information as possible. 
4. Complete the SAE Form. Fax the completed form accompanied by the demography 
CRF/eCRF, the Medical History CRF/eCRF, the Previous and Concomitant 
Medication/TherapiesCRF/eCRF, the AE CRF/eCRF, and any other relevant information 
(e.g. test results) immediately to GLLP at 682-831-9197. 
5. Monitor and record the progress of the event until it resolves or reaches a clinically stable 
outcome, with or without sequel. Every effort should be made to obtain further safety 
details and follow-up information from the subject and his/her doctors within limits 
described by local laws and regulations. 
6. Obtain and maintain in his/her files all pertinent medical records, information, and medical 
judgments from who may have assisted in the treatment and follow-up of the subject. If 
necessary, contact the subject’s personal physician or hospital to obtain further 
information. 
7. Inform GLLP of the ongoing progress and final outcome of the event. Send a revised or 
updated SAE Form, if appropriate to the above fax number. 
8. Comply with the applicable regulatory requirement(s) related to the reporting of serious 
adverse events to the regulatory authority (ies) and the IRB.  
 
8. 
STATISTICAL METHODS PLANNED  
8.1 
STATISTICAL AND ANALYTICAL PLANS 
A separate document, named the Statistical Analysis Plan (SAP), will be developed by Stephens 
during the conduct of the study and approved by GLLP prior to database lock. It will contain a 
more detailed and technical description of specific data conventions, calculations and of statistical 
procedures for executing the analyses that are specified in the sections of the protocol below.  
Any changes to the statistical analyses planned in the protocol will be justified and documented 
in the SAP if they were decided before database lock. Any change made to the SAP after the 
database lock will be documented in the final clinical study report as deviations from the planned 
analysis. 
8.1.1. Variables to be analyzed 
The following variables will be analyzed or summarized: 
8.1.1.1. Primary Variables 
 
Percent Change in Total Lesions at Week 12 
8.1.1.2. Secondary Variables 
 
Change in lesion count from baseline. 
 
Change in Investigator’s Global Assessment (IGA) 
 
Change in clinical grading of efficacy parameters through digital images from 
baseline. 
 
Subject self-assessment questionnaire at Weeks 1, 2, 6, 12, and 24.   
 
Change in tolerance grading from baseline. 
 
8.1.1.3. Safety Variables 
 
Incidence of adverse events 


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8.1.1.4. Data Transformations 
No data transformations are planned. 
8.1.2. Populations Analyzed, Evaluability and Limitation / Evaluation of Bias 
Statistical analyses will be performed based on the following subject populations.  
8.1.2.1. Intent-to-Treat (ITT) Population 
The ITT population is defined as all subjects who are randomized and have at least one post-
treatment administration evaluation. This is the primary population for efficacy analyses. All 
primary efficacy variables and secondary efficacy variables will be analyzed based on the ITT 
population. LOCF (Last Observation Carried Forward) will be used to impute missing efficacy data 
for this population.  
8.1.2.2. Safety Population 
The safety population is defined as all subjects who are enrolled and receive at least one dose of 
study product. In practice, only the subjects who return their study product unopened will be 
excluded from the safety population. Safety variables will be analyzed based on the safety 
population. 
8.1.3. Data Presentation and Graphics  
The subject disposition, demographics, baseline characteristics, compliance (number of missed 
applications, total number of applications, etc.), visit dates including informed consent date, 
inclusion/exclusion criteria, previous therapies and concomitant therapies by treatment will be 
listed or summarized. All primary and safety variables listed will be summarized at each visit. The 
categorical variables will be summarized by frequency and percentage for each response 
category (N, %). The continuous variables will be summarized using means, medians, minimum, 
maximum, and standard deviations (SD) for each visit.  
Additional summary tables will be provided for AEs that are considered serious (SAEs), related 
to the study product, and AEs leading to discontinuation. All AE summary tables are based on the 
number of subjects in safety population who have experienced AE(s). For a given AE, a subject 
will be counted once, even if he or she has experienced multiple episodes for that particular AE. 
8.2 
SAMPLE SIZE DETERMINATION 
Sample size is determined according to Sponsor’s recommendation.  
  
9. 
STUDY CONDUCT CONDISERATIONS 
9.1 
CLINICAL MONITORING 
The conduct of the study will be closely monitored by representatives of GLLP following GCP, 
ICH guidelines, applicable SOPs, regulatory guidelines and all local regulations. The clinical 
investigation will be monitored to ensure that:  the rights and well-being of the subjects are 
protected; the reported data are accurate, complete and verifiable from applicable source 
documents; and the study is conducted in accordance with the currently approved protocol and 
any other study agreements, GCP, and all applicable regulatory requirements. The investigator 


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will allow the GLLP representatives to have access to all study records, CRF, corresponding 
subject medical records, and any other documents considered source documentation. The 
investigator also agrees to assist the representatives, if required, which can include AE reporting.  
DATA COLLECTION 
Investigators must keep accurate records of all subjects' visits and all procedures done, being 
sure to include all pertinent study related information from which CRF/eCRF data will be recorded. 
Data for this study may be recorded in the subject's chart (e.g. source documents / electronic 
records) or if approved by the GLLP directly into CRF. If electronic records are maintained, the 
method of verification must be determined in advance of starting the study. A statement should 
be made indicating that the subjects have been enrolled in protocol GLI.04.SPR.US10329 and 
have been provided with a copy of the signed informed consent. The process of administering the 
informed consent must also be documented. Any and all side effects and AEs with the 
concomitant therapies associated must be thoroughly documented. Results of any diagnostic 
tests conducted during the study should be included in the source documentation. Pertinent 
telephone conversations with the subjects and/or GLLP concerning the study will be documented 
and kept on file. 
It is required that the author of an entry in the source documents be identifiable. Direct access to 
all source documentation (medical records) must be allowed for the purpose of verifying that the 
data recorded in the CRF/eCRF are consistent with the original source.  
Only designated individuals may complete the CRF. The principal investigator will review the 
reported data and certify that the CRF are accurate and complete.  
After monitoring has occurred at the clinical site(s) and the CRF have been reviewed, additional 
data clarifications and/or additions may be needed including AE reporting. Data clarifications 
and/or additions are documented and are part of each subject’s CRF. 
9.2 
QUALITY ASSURANCE / AUDIT / INSPECTION 
To ensure compliance with GCP and all applicable regulatory requirements, GLLP may conduct 
a quality assurance audit of the site records, and the regulatory agencies may conduct a 
regulatory inspection at any time during or after completion of the study. The investigator must 
agree to grant the auditor(s) and inspector(s) direct access to all relevant documents and to 
allocate their time and the time of their staff to discuss any findings/relevant issues.  
9.3 
RECORD RETENTION 
The investigator is required to maintain up-to-date, complete regulatory documentation as 
indicated by GLLP and the investigator’s files will be reviewed as part of the ongoing study 
monitoring. The records must be easily accessible when needed (e.g., for a Galderma 
Laboratories L.P.’s audit or regulatory inspection) and must be available for review in conjunction 
with assessment of the facility, supporting systems, and relevant site personnel. Financial 
information is not subject to regulatory inspection and should be kept separately.  
GLLP will inform the investigator of the time period for retaining the site records in order to comply 
with all applicable regulatory requirements. The minimum retention time will meet the strictest 
standard applicable to a particular site, as dictated by local laws/regulations, GLLP SOPs, and/or 
institutional requirements. 
The investigator should take measures to prevent accidental or premature destruction of these 
documents. If the investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. GLLP must be notified in writing of the name and address of the new 
custodian. 


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9.4 
CHANGES IN STUDY CONDUCT / AMENDMENTS 
No amendment will be done for modification(s) due to change in logistical or administrative aspect 
of the study (e.g., change in monitors, change of telephone numbers). In such a case, the 
appropriate institution(s) and/or person(s) will be notified of the changes. 
Modification of the protocol is prohibited without prior written agreement in the form of a protocol 
amendment. All amendments will be created by GLLP and must be approved by the IEC/IRB prior 
to implementation except when required to mitigate immediate safety risks or when the changes 
involve only logistical or administrative revisions.  
Amendments may necessitate that the informed consent and other study-related material be 
revised. If the consent form is revised, all patients/subjects currently enrolled in the study may be 
required by the IRB/IEC to sign the approved, revised informed consent form.  
 
10. 
ETHICS 
This study will be conducted in accordance with the HELSINKI Declaration (1964) and it’s TOKYO 
(1975), VENICE (1983), HONG-KONG (1989), SOMERSET WEST (1996) and EDINBURGH 
(2000), Washington (2002). Tokyo (2004), Seoul (2008), and Brazil (2013) amendments, the ICH 
Good Clinical Practice (GCP) guidelines, FDA Code of Federal Regulations (CFR), Health 
Insurance Portability and Accountability Act (HIPAA) and local regulatory requirements. The 
investigator and all clinical study staff will conduct the clinical study in compliance with the 
protocol. The investigator will ensure that all personnel involved in the conduct of the study are 
qualified to perform their assigned responsibilities through relevant education, training, and 
experience. 
Before clinical study initiation, this protocol, the informed consent form with any other written 
information given to subjects, and any advertisements planned for subject recruitment must be 
approved by an IEC/IRB. The investigator must provide documentation of the IEC/IRB approval 
to GLLP. The approval must be dated and must identify the applicable protocol, amendments (if 
any), informed consent form, all applicable recruiting materials, written information for subject, 
and subject compensation programs. The IEC/IRB will be provided with any periodic safety 
updates, and all other information required by local regulation and/or the IEC/IRB. At the end of 
the study, the investigator will notify the IEC/IRB about the study’s completion. The IEC/IRB also 
will be notified if the study is terminated prematurely. Finally, the investigator will report to the 
IEC/IRB on the progress of the study at intervals stipulated by the IEC/IRB. 
Voluntary informed consent will be obtained from every subject prior to the initiation of any 
screening or other study-related procedures. The investigator must have a defined process for 
obtaining consent. Specifically, the investigator, or designee, will explain the clinical study to each 
potential subject and the subject must indicate voluntary consent by signing and dating the 
approved informed consent form. The subject must be provided an opportunity to ask questions 
of the investigator, and if required by local regulation, other qualified personnel. The investigator 
must provide the subject with a copy of the consent form written in a language the subject 
understands. The consent document must meet all applicable local laws and will provide subjects 
with information regarding the purpose, procedures, requirements, and restrictions of the study, 
along with any known risks and potential benefits of the study product, the available 
compensation, and the established provisions for maintaining confidentiality of personal, 
protected health information. Subjects will be told about the voluntary nature of participation in 
the study and will be provided with contact information for the appropriate individuals should 
questions or concerns arise during the study. The subject also will be told that their records may 
be accessed by appropriate authorities and Sponsor-designated personnel. The investigator must 
keep the original, signed copy of the consent and must provide a duplicate copy to each subject. 
 
 


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11. 
STUDY FLOW CHART 
 
 
11.1 
Study flow chart  
 
 
PROCEDURES 
Study Visits 
Visit 1 
Screening a 
Visit 2 
Baseline a 
 
Visit 
3 
Week 
1 
(±2 
Days) 
/Early 
Exit 
Visit 
4 
Week 
2 
(±2 
Days) 
/Early 
Exit 
Visit 
5 
Week 
6 
(±3 
Days) 
/Early 
Exit 
Visit 6 
Week 
12 
(±3 
Days)/Early 
Exit 
Visit 7 
Week 
18 
(±3 
Days)/Early 
Exit 
Visit 8 
Week 
24 
(±3 
Days)/Early 
Exit 
Unscheduled 
Visit (USV)c 
Informed Consent 
X 
 
 
 
 
 
 
 
 
Inclusion/Exclusion Criteria 
X 
X 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
Previous Therapies & Procedures 
X 
 
 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
 
 
Urine pregnancy test 
X 
 
 
 
 
 
 
X 
X 
Diaries Dispensed/Collected 
 
X 
 
X 
X 
X 
X 
X 
X 
Concomitant  therapies & 
procedures 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Lesion count 
X 
X 
X 
X 
X 
X 
 
X 
X 
IGA 
X 
X 
X 
X 
X 
X 
 
X 
X 
Clinical 
Grading 
of 
Efficacy 
Parameters through digital images  
 
X 
 
 
X 
X 
 
X 
X 
Clinical Grading of Tolerance 
Parameters 
X 
X 
X 
X 
X 
X 
 
X 
X 
Imaging procedures 
 
X 
 
 
X 
X 
 
X 
X 
Self-Assessment Questionnaire 
 
 
X 
X 
X 
X 
 
X 
X 
Test Products dispensing 
 
X 
 
 
X 
X 
X 
X 
X 
Adverse Events b  
 
X 
X 
X 
X 
X 
X 
X 
X 
Exit Form 
 
 
 
 
 
 
 
X 
X 
a Screening and Baseline visit may be combined. 
b Adverse events are to be collected starting from the signing of the Informed Consent Form.   
c If a subject is discontinued at Week 1, Week 2, Week 6, Week 12, Week 18 or USV, Week 24/Exit or Early 
Exit Procedures are to be completed 


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12. 
REFERENCES 
 
 
1. U.S. Food and Drug Administration. Guidance for industry: acne vulgaris: developing 
drugs for treatment. September 2005. http://www.fda.gov. 
2. Shai, A., Maibach, HI, Baran, R. Baran.  Acne in Handbook of Cosmetic skin Care. 
Publisher Martin Duntiz Ltd., Chapter 9, 81-100, 2001. 
3. Rizer, RL, Mills, OH, Trookman, NS. The assessment of acne: a re-evaluation of grading 
strategies. Scientific Poster, Annual Meeting of the Am. Acad. Dermatol (2001). 
4. Griffiths CE, Wang TS, Hamilton TA, Voorhees JJ, Ellis CN. A photonumeric scale for the 
assessment of cutaneous photodamage. Arch Dermatol. 1992 Mar;128(3):347-351. 
 
 
13. 
ATTACHMENTS 
Attachment 12.1 – Elements of Informed Consent  
Attachment 12.2 – Assessment Scale and Descriptions 
13.1 
ELEMENTS OF INFORMED CONSENT 
The following information must be provided to each subject in obtaining informed consent. If 
written consent is being obtained, the subject (or subject’s legal representative) should be 
provided with a copy of the signed written informed consent. 
1. State that the study involves RESEARCH. 
a. Explain the PURPOSES of the research 
b. State the expected DURATION of the subject’s participation 
c. Explain the trial treatments 
d. Describe the PROCEDURES to be followed  
e. Identify any EXPERIMENTAL procedures 
f. Explain the subject’s responsibilities 
2. Describe any reasonably foreseeable RISKS OR DISCOMFORTS to the subject (skin 
irritation) 
3. Describe any BENEFITS to the subject or to others which may reasonably be expected 
from research 
4. Note appropriate ALTERNATIVE procedures or courses of treatment, if any that might be 
advantageous to the subject. 
5. Describe the extent, if any, to which CONFIDENTIALITY of records identifying the subject 
will be maintained. Note that the monitors, the auditors, the IRB and the Food and Drug 
Administration (FDA) will be granted access to the subject’s original medical records for 
verification of clinical trial procedures and/or data without violating the confidentiality of the 
subject, to the extent permitted by the applicable laws and regulations and that by signing 
a written informed consent form, the subject or the subject’s legally acceptable 
representative is authorizing such access. 
6. Describe the anticipated prorated payment, if any, to the subject for participating in the 
trial. 
7. For research involving more than minimal risk, explain if any COMPENSATION or medical 
treatments are available should injury occur. If so, explain (a) what they consist of, OR (b) 
where further information may be obtained.  
8. Tell whom to contact for ANSWERS to pertinent questions about (a) the research and (b) 
research subject’s rights. 


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9. State that: 
a. participation is VOLUNTARY 
b. refusal to participate will involve NO PENALTY or loss of benefits to which the 
subject is otherwise entitled, and 
c. the subject MAY DISCONTINUE participation at any time without penalty or loss 
of benefits to which the subject is otherwise entitled 
 
Additional Elements of Informed Consent 
When appropriate, one or more of the following elements of information shall also be provided to 
each subject. 
1. A statement that the particular treatment or procedure may involve risks to the subject 
which are currently unforeseeable. 
2. Any additional costs to the subject that may result from participation in the research. 
3. The consequences of a subject’s decision to withdraw from the research and procedures 
for orderly termination of participation by the subject. 
4. A statement that significant new findings developed during the course of the research 
which may relate to the subject’s willingness to continue participation will be provided  to 
the subject or the subject’s legally acceptable representative in a timely manner. 
5. The approximate number of subjects involved in the study. 
6. A statement that a description and/or summary of this clinical trial will be available on 
www.clinicaltrials.gov, as required by U.S. Law. The subject may review the information 
posted in this web site at any time. The web site will not include information that can 
identify the subject. 
References:  
21 CFR Part 50.25 – Protection of Human Subjects, Basic Elements of Informed Consent  
International Conference on Harmonization Guidance for Industry E6 Good Clinical Practice: 
Consolidated Guidance, 4.8 Informed Consent of Trial Subjects (April 1996) 
The informed consent requirements in these regulations are not intended to pre-empt any 
applicable federal, state, or local laws. 
 
 
 


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13.2 
Assessment Scales and Descriptions 
13.2.1. Lesion Count 
Clinic Day Assessments: Screening/Baseline, Week 1, Week 2, Week 6, Week 12, Week 24  
A trained grader will count and record the number of open comedones, closed comedones 
papules, and pustules on each subject’s face. Note that papules and pustules are classified as 
inflammatory acne lesions while open and closed comedones are classified as non-inflammatory 
lesions.  
 
Acne lesion counts will be assessed globally on the face for each of the following facial 
locations/quadrants: forehead, left cheek, chin (including the area above the upper lip), and right 
cheek. Lesions on the nose, under the jaw line or along the hairline (including eye brows) will not 
be included in the counts.3 
 
13.2.2. Investigator’s Global Assessment (IGA)  
Clinic Day Assessments: Screening/Baseline, Week 1, Week 2, Week 6, Week 12, and Week 
24  
A trained grader will evaluate each subject’s global face for Investigator’s Global Improvement 
Assessment.  
 
FDA Investigator’s Global Assessment of Acne Severity scale 
0 
Clear 
No inflammatory or non-inflammatory lesions 
1 
Almost 
Clear 
Rare non-inflammatory lesions with no more than one small 
inflammatory lesion 
2 
Mild 
Greater than Grade 1, some non-inflammatory lesions with no 
more than a few inflammatory lesion (papules/pustules only, no 
nodular lesions) 
3 
Moderate 
Greater than Grade 2, up to many non-inflammatory lesions and 
may have some inflammatory lesions, but no more than one 
small nodular lesion 
4 
Severe 
Greater than Grade 3, up to many non-inflammatory and 
inflammatory lesions, but no more than a few nodular lesions 
 
13.2.3. Clinical Grading of Efficacy Parameters through digital images 
Clinic Day Assessments: Baseline, Week 6, Week 12, and Week 24  
Stephen’s trained grader will evaluate each digital images for clinical grading of efficacy 
parameters. The efficacy parameters will be assessed globally on each subject’s face using a 
modified Griffiths’ 10-point scale4 according to the following numerical definitions (half-point 
scores may be used as necessary to more accurately describe the skin condition):  
0 = none (best possible condition) 
1 to 3 = mild 
4 to 6 = moderate  
7 to 9 = severe (worst possible condition) 
 
The following parameters will be evaluated using the indicated scale anchors:  
 
 
Parameter 
0 = 
9 = 
Skin texture 
Smooth, even looking skin 
Rough, uneven looking skin 


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Parameter 
0 = 
9 = 
texture 
texture 
Skin tone evenness 
Even skin tone 
Severely uneven skin tone 
Clarity 
 Translucent skin appearance 
Dull/flat matte skin appearance 
Overall skin complexion 
Excellent 
Poor 
 
13.2.4. Clinical Grading of Tolerability Parameters  
Tolerability evaluations will be performed at screening, baseline, and weeks 1, 2, 6, 12, and 24. Local 
cutaneous tolerability will be evaluated by assessing the signs and symptoms of erythema, dryness, 
and scaling, and by subject reporting of the degree of stinging/burning on the global face (treatment 
area).  
 
For subject assessments of subjective irritation, subjects will report the degree of any parameters that 
they typically experience when using a product similar to the test material(s) at the baseline visit. At 
post-baseline time points, subjects will report the degree of any of these symptoms they have 
experienced since the previous time point.  
 
The following static (without reference to any prior visits) scales and definitions will be used for 
tolerability evaluations (with half-point scores used as necessary to better describe the clinical 
condition):  
 
Objective Irritation Parameters 
 
Erythema 
0 = None 
No erythema of the treatment area 
1 = Mild 
Slight, but definite redness of the treatment area 
2 = Moderate 
Definite redness of the treatment area 
3 = Severe 
Marked redness of the treatment area 
 
Dryness 
0 = None 
No dryness of the treatment area 
1 = Mild 
Slight, but definite dryness of the treatment area 
2 = Moderate 
Definite dryness of the treatment area 
3 = Severe 
Marked dryness of the treatment area 
 
Scaling 
0 = None 
No scaling of the treatment area 
1 = Mild 
Barely perceptible, fine scales in limited areas of the treatment area 
2 = Moderate 
Fine scaling generalized to all areas of the treatment area 
3 = Severe 
Scaling and peeling of skin over all areas of the treatment area 
 
Subjective Irritation Parameters 
 
Burning/stinging 
0 = None 
No burning/stinging of the treatment area 
1 = Mild 
Slight burning/stinging sensation of the treatment area; not really bothersome 
2 = Moderate 
Definite warm, burning/stinging of the treatment area that is somewhat 
bothersome 
3 = Severe 
Hot burning/marked stinging sensation of the treatment area that causes definite 
discomfort and may interrupt daily activities and/or sleep 


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13.2.5. 
Digital images 
Clinic Day Assessments: Baseline, Week 6, Week 12, and Week 24  
Prior to photography procedures, clinic personnel will ensure that subjects have a clean face with 
no makeup as described in the study procedures. Subjects will remove any jewelry from the 
area(s) to be photographed and equilibrate for at least 15 minutes to ambient conditions (68-75ºF 
and 35-65% humidity) within the clinic before any photographs are taken. 
 
VISIA Imaging: 
Subjects will be provided with a black or gray matte headband to keep hair away from the face 
and instructed on proper headband placement. Subjects will be provided with a black matte shirt 
or a black or gray matte cloth will be draped over the subjects’ clothing. Subjects will be instructed 
to adopt neutral, non-smiling expressions with their eyes gently closed. Subjects will be carefully 
positioned for each photograph, for the center, right, and left side views.  
 
Full-face digital images will be taken of each subject (right side, left side, and center views) using 
the VISIA CR photo-station (Canfield Imaging Systems, Fairfield, New Jersey) with a Canon Mark 
II 5D or 6D digital SLR camera (Canon Incorporated, Tokyo, Japan) under the following lighting 
conditions:     
Standard lighting 1 
Standard lighting 2 
Cross-polarized 
Parallel polarized 
UV fluorescence 
 
Visible Light Imaging (Beauty shot) 
For subjects completing at sites 1 and 2 (Stephens’ Texas and Colorado locations), digital images 
will be taken of each subject’s face using visible light. Full-face images will be taken of each 
subject’s center view. Subjects will not be wearing any headband or using any headrest/chinrest. 
Subjects will be instructed to adopt neutral, non-smiling expressions with their eyes open.  
13.2.6. 
Self-Assessment Questionnaires 
Clinic Day Assessments: Week 1, Week 2, Week 6, Week 12, and Week 24  
Subjects will be asked to complete a self-assessment questionnaire.  This  questionnaire has a 
5-point Likert Response Scale (1=Strongly Agree; 5=Strongly Disagree).  Responses for each 
item will be transformed into percent agreement (percentage of subjects with a score of 1 or 2) 
and presented descriptively.  The individual items will be asked at the indicated time points: 
 
Questions 
Visit 2: 
Week 1 
Visit 3: 
Week 2 
Visit 4: 
Week 6 
Visit 5: 
Week 12 
Visit 7: 
Week 24 
I experienced noticeable improvement in my 
skin tone 
  
  
  
X 
X 
I experienced noticeable improvement in my 
skin texture 
  
  
  
X 
X 
I experienced noticeable improvement in my 
skin radiance 
  
  
  
X 
X 
My skin has a more youthful appearance 
  
  
  
X 
X 
My skin is clearer skin using this treatment 
  
X 
X 
X 
X 


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I feel my skin is now clear 
  
  
X 
X 
X 
This treatment works faster than my previous 
acne treatment. 
X 
X 
  
  
  
This treatment is strong enough to give me 
clear, acne free skin. 
  
  
  
X 
X 
The treatment helped to reduce redness and 
inflammation caused by my acne. 
  
  
X 
X 
X 
I feel that this treatment deep cleans and 
unblocks my pores. 
X 
X 
X 
  
  
This treatment visually minimized my pore 
size. 
  
  
X 
X 
X 
I noticed an improvement in my acne. 
Strongly agree to Strongly disagree 
X 
X 
  
  
X 
This treatment reduces my acne without 
leaving behind dry, flakey skin. 
  
  
X 
X 
X 
I have noticed I had fewer breakouts than my 
previous treatments.                                                
X 
X 
X 
X 
X 
My skin looks better than before 
  
  
X 
X 
X 
This treatment breaks my cycle of acne and 
keeps my skin clear                                                   
  
  
  
X 
X 
I saw improvement in the overall health of my 
skin since starting the regimen     
X 
  
X 
X 
X 
My skin looks noticeably smoother and 
healthier 
  
  
X 
X 
  
The areas of my skin where I used to have 
acne is now clear and radiant after daily 
treatment.                                                                  
  
X 
X 
X 
X 
I feel better about my skin  since I’ve started 
the treatment regimen 
  
  
X 
X 
X 
I feel more confident since I’ve started the 
treatment 
  
  
X 
X 
X 
Has your quality of life improved now that 
you have started using this product? 
  
  
  
X 
X 
I would continue using this treatment beyond 
24 weeks as a regular part of my skincare 
routine. 
  
  
  
  
X 
What is your overall satisfaction with the 
regimen? 
  
  
X 
X 
X 
I have noticed a positive difference in the 
appearance of my skin with this regimen. 
  
  
X 
X 
X 
This once a day regimen is easy to use every 
day. 
X 
  
X 
  
  
I liked the feel of this product. 
X 
  
 
  
  
I would recommend this product to others. 
  
  
  
X 
X 
My acne is as clear as if I went to a doctor or 
received a prescription. 
  
  
  
X 
X 


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I don’t feel the need for a prescription after 
using this product. 
  
  
  
X 
X 
Total: 
7 
6 
16 
24 
25 
 
 
 
 
 




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APPENDIX I: FITZPATRICK SKIN TYPE 
 
The Fitzpatrick skin classification is based on the skin’s unprotected response to the first 30 to 45 minutes 
of sun exposure after a winter season without sun exposure.  The categories of skin types are as follows: 
 
I 
White; very fair; red or blonde hair; blue eyes; freckles 
Always burns easily; never tans 
II 
White; fair; red or blonde hair; blue, hazel, or green eyes 
Always burns easily; tans minimally 
III 
Cream white; fair with any eye or hair color; very common 
Burns moderately; tans gradually 
IV 
Brown; typical Mediterranean white skin 
Burns minimally; always tans well 
V 
Dark Brown; mid-eastern skin types, black hair, olive skin 
Rarely burns; tans profusely 
VI 
Black; black hair, black eyes, black skin 
Never burns; deeply pigmented 
 
 
 

SAP_001.pdf: 


GALDERMA LABORATORIES, L.P.  
 
CONFIDENTIAL 
Protocol GLI.04.SPR.US10354 
 
SAP Date:  22 April 2016 Version 1.0 
 
Page 2 of 15 
 
 
Table of Contents 
Table of Contents .................................................................................................................................................... 2 
1 
Abbreviations and Definitions ....................................................................................................................... 3 
2 
Introduction .................................................................................................................................................... 4 
2.1 
Purpose of the Analyses ........................................................................................................................ 4 
3 
Study Objectives and Endpoints .................................................................................................................... 4 
3.1 
Study Objectives ................................................................................................................................... 4 
3.2 
Endpoints............................................................................................................................................... 4 
3.3 
Derived Variables .................................................................................................................................. 4 
4 
Study Methods ............................................................................................................................................... 5 
4.1 
General Study Design and Plan ............................................................................................................. 5 
4.2 
Inclusion-Exclusion Criteria and General Study Population ................................................................. 6 
4.3 
Study Variables ..................................................................................................................................... 7 
4.3.1 
Lesion Count (Clinic Day Assessments: Screening/Baseline, Week 1, Week 2, Week 6, Week 12, 
Week 24) 7 
4.3.2 
Investigator’s Global Assessment (IGA) (Clinic Day Assessments: Screening/Baseline, Week 1, 
Week 2, Week 6, Week 12, and Week 24) .................................................................................................... 7 
4.3.3 
Clinical Grading of Efficacy Parameters though Digital Images (Clinic Day Assessments: Baseline, 
Week 6, Week 12, and Week 24) ................................................................................................................... 8 
4.3.4         Tolerability Evaluation (Clinic Day Assessments: Screening/Baseline, Week 1, Week 2, Week 
6, Week 12, Week 24) ……………………………………………………………………………..8 
 
4.3.5 
Digital Images (Clinic Day Assessments: Baseline, Week 6, Week 12, and Week 24) 
…..9 
4.3.6 
Self-Assessment Questionnaires (Clinic Day Assessment: Baseline, Week 1, Week 2, Week 6, 
Week 12, and Week 24) ................................................................................................................................. 9 
5 
Sample Size .................................................................................................................................................. 10 
6 
General Considerations ................................................................................................................................ 10 
6.1 
Timing of Analyses ............................................................................................................................. 10 
6.2 
Analysis Populations ........................................................................................................................... 10 
6.2.1 
Intent-to-Treat (ITT) Population ................................................................................................. 11 
6.2.2 
Safety Population ........................................................................................................................ 11 
6.3 
Missing Data ....................................................................................................................................... 11 
6.4 
Interim Analyses and Data Monitoring ............................................................................................... 11 
7 
Summary of Study Data ............................................................................................................................... 11 
7.1 
Subject Disposition ............................................................................................................................. 11 
7.2 
Protocol Deviations ............................................................................................................................. 11 
7.3 
Demographic and Baseline Variables ................................................................................................. 11 
7.4 
Medical History and Current Medical Condition ................................................................................ 12 
7.5 
Prior and Concomitant Medications/Therapies ................................................................................... 12 
7.6 
Treatment Compliance ........................................................................................................................ 12 
8 
Efficacy Analyses ........................................................................................................................................ 12 
8.1 
Lesion Count, Investigator’s Global Assessment (IGA), Clinical Grading of tolerance parameters and 
Clinical Grading of Efficacy Parameters through Digital Images .................................................................... 12 
8.2 
Subject Satisfaction Questionnaire ...................................................................................................... 12 
9 
Safety Analyses ............................................................................................................................................ 13 
9.1 
Adverse Events, Serious Adverse Events and other Significant Adverse Events ............................... 13 
9.2 
Pregnancies ......................................................................................................................................... 13 
10 
Reporting Conventions ................................................................................................................................ 13 
11 
Technical Details.......................................................................................................................................... 13 
12 
Listing of Tables, Listings and Figures ........................................................................................................ 13 
13 
References .................................................................................................................................................... 15 
  
 
 
 
 
 


GALDERMA LABORATORIES, L.P.  
 
CONFIDENTIAL 
Protocol GLI.04.SPR.US10354 
 
SAP Date:  22 April 2016 Version 1.0 
 
Page 3 of 15 
 
1 
Abbreviations and Definitions 
AE  
Adverse Event 
CRF 
Case Report Form 
eCRF 
Electronic Case Report Form 
etc. 
et cetera 
e.g.  
for example (Latin; exempla gratia) 
FDA 
The Food and Drug Administration 
GCP 
Good Clinical Practice 
GLLP 
Galderma Laboratories, L.P. 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
ICH 
International Conference on Harmonization  
IEC 
Independent Ethics Committee 
IPL 
Intesnse Pulse Light 
IRB 
Institutional Review Board 
LOCF 
Last Observation Carried Forward 
N or n 
Number 
OTC 
Over-the-Counter 
% 
Percent 
P  
Probability (as in significance level) 
Rx 
Prescription 
SAE 
Serious Adverse Event 
SAP 
Statistical Analyses Plan 
SD 
Standard deviation 
SOP 
Standard Operating Procedure 
i.e.  
that is (Latin:  id est) 
USV 
Unscheduled Visit 
 
 
 


GALDERMA LABORATORIES, L.P.  
 
CONFIDENTIAL 
Protocol GLI.04.SPR.US10354 
 
SAP Date:  22 April 2016 Version 1.0 
 
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2 
Introduction 
 
2.1 
Purpose of the Analyses 
 
Acne is an inflammatory disease of the sebaceous gland that occurs during adolescence and persists into adulthood. 
Non-inflammatory acne lesions form when the opening of the follicle becomes blocked by the presence of dense 
keratin and sebum. Inflammatory acne lesions develop when the orifice of the follicle becomes completely occluded 
and bacteria replicate and excrete substances that induce an inflammatory reaction.  
 
Treatment with acne medications has been shown to help dissolve keratin plugs and help prevent the proliferation of 
bacteria in the sebaceous gland. This results in a reduction in the numbers of non-inflammatory and inflammatory 
acne lesions.1,2 
 
The multicenter, double-blind, randomized, controlled clinical trial is being conducted to evaluate the efficacy of 2 
acne treatments for 24 weeks of use in adult men and women 21 to 45 years of age with mild to moderate facial 
acne, with at least 5 inflammatory lesions, and 10 – 100 non-inflammatory lesions. 
 
3 
Study Objectives and Endpoints 
 
3.1 
Study Objectives 
 
 
To characterize the effect of the acne treatment in lesion count at week 1, week 2, week 6, week 12, and week 
24 as compared to baseline and compare between treatments 
 
To characterize the effect of the acne treatment in Investigator’s Global Assessment at week 1, week 2, week 6, 
week 12, and week 24 as compared to baseline and compare between treatments 
 
To characterize the effect of the acne treatment in clinical grading of efficacy parameters through digital images 
at week 6, week 12, and week 24 as compared to baseline and compare between treatments 
 
To characterize the effect of the acne treatment in subject self-assessment questionnaire responses at week 1, 
week 2, week 6 week 12, and week 24 as compare between treatments 
 
To characterize the effect of objective irritation parameters and subjective irritation parameters at week 1, week 
2, week 6, week 12, and week 24 as compared to baseline and compare between treatments 
 
Monitoring of adverse events throughout the course of the study. 
 
3.2 
Endpoints 
 
Clinic assessment:  
 
Lesion count at baseline, week 1, week 2, week 6, week 12, and week 24. 
 
Investigator’s Global Assessment  (IGA) at baseline, week 1, week 2, week 6, week 12, and week 24. 
 
Clinical grading of efficacy parameters through digital images taken at baseline, week 6, week 12, and 
week 24. 
 
Clinical grading of tolerance parameters at baseline, week 1, week 2, week 6, week 12, and week 24. 
 
Digital images at baseline, week 6, week 12, and week 24. 
 
Subject self-assessment: 
 
Subject self-assessment questionnaires at week 1, week 2, week 6 week 12, and week 24 
 
Safety: 
 
Number of adverse events 
 
3.3 
Derived Variables 
 
None 


GALDERMA LABORATORIES, L.P.  
 
CONFIDENTIAL 
Protocol GLI.04.SPR.US10354 
 
SAP Date:  22 April 2016 Version 1.0 
 
Page 5 of 15 
 
 
4 
Study Methods 
 
4.1 
General Study Design and Plan 
 
 
This is a multicenter, double-blind, randomized, controlled clinical trial to be conducted in the United States at 4 
testing facilities. The study will examine the effect of 2 acne treatments (Product A when used once daily and 
Product B when used 1-3 times a day) for 24 weeks in adult men and women 21 to 45 years of age with mild to 
moderate facial acne, with at least 5 inflammatory lesions, and 10 – 100 non-inflammatory lesions at enrollment. 
Subjects meeting the inclusion/exclusion criteria are to be enrolled in the study. There will be up to 8 visits 
during the course of the study: Screening, Baseline, Week 1, Week 2, Week 6, Week 12, Week 18, and Week 
24. 
 
Approximately 130 subjects will be enrolled to complete with 100 subjects (50 per cell). For the purposes of this 
protocol, enrolled is defined as a subject who has been consented, screened and eligibility has been verified. 
Each site is to enroll no more than 40 subjects, with at least 100 subjects expected to complete when combined. 
 
Adverse event assessments will be conducted for all subjects at every visit after Informed Consent is signed. 
 
Type of control(s): No controls.  
 
Level and method of blinding: Double-blind. 
 
Method of treatment assignment: Randomized to use Product A or Product B. 
 
Sequence and duration of all study periods:  
 
 
 
 
 


GALDERMA LABORATORIES, L.P.  
 
CONFIDENTIAL 
Protocol GLI.04.SPR.US10354 
 
SAP Date:  22 April 2016 Version 1.0 
 
Page 6 of 15 
 
4.2 
Inclusion-Exclusion Criteria and General Study Population 
Inclusion Criteria  
 
1. Men and women age 21 to 45 years at the time of enrollment. 
2. Individuals with mild to moderate acne (score of 2-3 on FDA Investigator’s Global Assessment Scale1) 
on the face. 
3. Individuals with at least 5 inflammatory lesions. 
4. Individuals with 10 – 100 non-inflammatory lesions. 
5. Individuals willing to use the test products as instructed for 24 weeks.  
6. Fitzpatrick skin type I-VI). 
7. Individuals willing and able to comply with all of the time commitments and procedural requirements 
of the clinical trial protocol. 
8. Individuals willing to provide written informed consent including photo release, Health Insurance 
Portability and Accountability Act (HIPAA), and are able to read, speak, write, understand English and 
are willing to share personal information and data, as verified by signing a written authorization at the 
screening. 
9. Willing to withhold all facial treatments during the course of the study including botulinum toxin, 
injectable fillers, microdermabrasion, IPL, peels, facials, laser treatments and tightening treatments.  
Waxing and threading is allowed but not facial laser hair removal. 
10. Males who are regular shavers and willing to shave on the day of the study visits (prior to clinic visits). 
11. Women of child bearing potential who are willing to take a urine pregnancy test prior to study 
enrollment, at week 24, and when deemed appropriate by the Investigator and/or Sponsor. 
12. Individuals of child bearing potential who use an acceptable method of contraception throughout the 
study.  Acceptable methods of birth control include: 
 
Oral and other system contraceptives. Individuals must be on a stable use for 3 months prior to 
study enrollment. Individuals on oral contraceptives must not alter their use, including dose or 
regimen for the duration of the study 
 
Double barrier 
 
Bilateral tubal ligation 
 
Partner vasectomy 
 
Abstinence 
13. Individuals willing to follow study requirements and report any changes in health status or medications, 
adverse event symptoms, or reactions immediately. 
14. Subjects must be stable on any medication they are taking for at least 30 days  
 
Exclusion Criteria  
 
1. Individuals diagnosed with allergies to topical acne products. 
2. Individuals having a condition and/or disease of the skin that the Investigator deems inappropriate for 
participation. 
3. Women who are nursing, pregnant, or planning to become pregnant during the study. 
4. Individuals who have pre-existing or dormant dermatologic conditions on the face (e.g., psoriasis, rosacea, 
eczema, seborrheic dermatitis, severe excoriations etc.) which in the opinion of the Investigator could 
interfere with the outcome of the study. 
5. Individuals with a history of immunosuppression/immune deficiency disorders (including (HIV infection or 
AIDS) 
or 
currently 
using 
immunosuppressive 
medications 
(e.g., 
azathioprine, 
belimumab, 
cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, 
Stelara.).  
6. Individuals with an uncontrolled disease such as asthma, diabetes, hypertension, hyperthyroidism, or 
hypothyroidism. Individuals having multiple health conditions may be excluded from participation even if 
the conditions are controlled by diet, medication, etc. at the Investigator’s discretion. 
7. Individuals who are currently participating in another facial usage study or have participated in a clinical 
trial within 4 weeks prior to inclusion into the study. 
8. Individuals with a history of skin cancer on the face within the past 5 years. 
9. Individuals with any planned surgeries and/or invasive medical procedures during the course of the study. 
10. Individuals who started hormone replacement therapies (HRT) or hormones for birth control less than 3 
months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for 
birth control during the study. 
11. Individuals with facial sunburn or excessive tanned facial skin or that are not willing to avoid daily sun 


GALDERMA LABORATORIES, L.P.  
 
CONFIDENTIAL 
Protocol GLI.04.SPR.US10354 
 
SAP Date:  22 April 2016 Version 1.0 
 
Page 7 of 15 
 
exposure on the face and the use of tanning beds or sunless tanning products for the duration of the study. 
12. Individuals with severe acne, acne conglobata, multiple nodules or cysts (more than 2). 
13. Individuals currently taking a natural or prescription testosterone blocker (e.g. saw palmetto, blask cohosh, 
chaste tree, chasteberry, spironolactone, drospirenone, progestins). 
14. Individuals currently on a testosterone booster or prescription testosterone (e.g. DHEA, tribulus, 
testosterone 
cypionate, 
testosterone 
enanthate, 
Sustanon, 
testosterone 
propionate, 
testosterone 
phenylpropriate, Omnadren etc.). 
15. Individuals that are currently taking or have taken within the last 30 days oral or topical prescription 
medications for acne such as Doxycycline, Minocycline, Clindamycin, Bactrim, Tetracycline, 
Erythromycin, Vibramycin and topical tretinoin.(Retin A Renova, Adapalene, Tazarotene), Azelaic acid, 
benzoyl peroxide, Dapsone, Sodium sulfacetamide, Differin, Epiduo. 
16. Individuals that have used oral isotretinoin (Accutane) within the past 6-months. 
17. Individuals routinely using (3x a week or more) topical OTC acne product (e.g. benzoyl peroxide, salicylic 
acid, alpha hydroxyl, beta hydroxyl and/or poly-hydroxy products or medicated cleansers, wipes, masks, 
scrubs, gels and creams) within 14 days of the study entry. 
18. Individuals using or who have used any systemic medication considered to affect the course of acne, 
specifically, but not exclusively antibiotics or steroids within the last 30 days prior to entry into the study. 
19. Individuals with excessive facial hair, including beard, mustache or goatee, or scars, which could interfere 
with evaluations by Investigator or designee. 
 
4.3 
Study Variables 
 
4.3.1 
Lesion Count (Clinic Day Assessments: Screening/Baseline, Week 1, Week 2, Week 6, Week 12, Week 
24) 
 
A trained grader will count and record the number of open comedones, closed comedones papules, and pustules on 
each subject’s face. Note that papules and pustules are classified as inflammatory acne lesions while open and closed 
comedones are classified as non-inflammatory lesions.  
 
Acne lesion counts will be assessed globally on the face for each of the following facial locations/quadrants: 
forehead, left cheek, chin (including the area above the upper lip), and right cheek. Lesions on the nose, under the 
jaw line or along the hairline (including eye brows) will not be included in the counts3. 
 
4.3.2 
Investigator’s Global Assessment (IGA) (Clinic Day Assessments: Screening/Baseline, Week 1, Week 
2, Week 6, Week 12, and Week 24) 
 
A trained grader will evaluate each subject’s global face for Investigator’s Global Improvement Assessment.  
 
FDA Investigator’s Global Assessment of Acne Severity scale 
0 
Clear 
No inflammatory or non-inflammatory lesions 
1 
Almost Clear 
Rare non-inflammatory lesions with no more than one small inflammatory 
lesion 
2 
Mild 
Greater than Grade 1, some non-inflammatory lesions with no more than a 
few inflammatory lesion (papules/pustules only, no nodular lesions) 
3 
Moderate 
Greater than Grade 2, up to many non-inflammatory lesions and may have 
some inflammatory lesions, but no more than one small nodular lesion 
4 
Severe 
Greater than Grade 3, up to many non-inflammatory and inflammatory 
lesions, but no more than a few nodular lesions 
 


GALDERMA LABORATORIES, L.P.  
 
CONFIDENTIAL 
Protocol GLI.04.SPR.US10354 
 
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Page 8 of 15 
 
 
4.3.3 
Clinical Grading of Efficacy Parameters though Digital Images (Clinic Day Assessments: Baseline, 
Week 6, Week 12, and Week 24) 
 
Stephen’s trained grader will evaluate each digital images for clinical grading of efficacy parameters. The efficacy 
parameters will be assessed globally on each subject’s face using a modified Griffiths’ 10-point scale according to 
the following numerical definitions (half-point scores may be used as necessary to more accurately describe the skin 
condition):  
0 = none (best possible condition) 
1 to 3 = mild 
4 to 6 = moderate  
7 to 9 = severe (worst possible condition) 
The following parameters will be evaluated using the indicated scale anchors:  
 
 
Parameter 
0 = 
9 = 
Skin texture 
Smooth, even looking skin texture 
Rough, uneven looking skin texture 
Skin tone evenness 
Even skin tone 
Severely uneven skin tone 
Clarity 
 
Translucent skin appearance 
Dull/flat matte skin appearance 
Overall skin complexion 
Excellent 
Poor 
 
4.3.4 
Tolerability Evaluation (Clinic Day Assessments: Screening/Baseline, Week 1, Week 2, Week 6, Week 
12, Week 24) 
 
Tolerability evaluations will be performed at screening, baseline, and weeks 1, 2, 6, 12, and 24. Local cutaneous 
tolerability will be evaluated by assessing the signs and symptoms of erythema, dryness, and scaling, and by 
subject reporting of the degree of stinging/burning on the global face (treatment area).  
For subject assessments of subjective irritation, subjects will report the degree of any parameters that they 
typically experience when using a product similar to the test material(s) at the baseline visit. At post-baseline 
time points, subjects will report the degree of any of these symptoms they have experienced since the previous 
time point.  
The following static (without reference to any prior visits) scales and definitions will be used for tolerability 
evaluations (with half-point scores used as necessary to better describe the clinical condition):  
 
Objective Irritation Parameters 
Erythema 
0 = None 
No erythema of the treatment area 
1 = Mild 
Slight, but definite redness of the treatment area 
2 = Moderate 
Definite redness of the treatment area 
3 = Severe 
Marked redness of the treatment area 
 
Dryness 
0 = None 
No dryness of the treatment area 
1 = Mild 
Slight, but definite dryness of the treatment area 
2 = Moderate 
Definite dryness of the treatment area 
3 = Severe 
Marked dryness of the treatment area 
 
Scaling 
0 = None 
No scaling of the treatment area 
1 = Mild 
Barely perceptible, fine scales in limited areas of the treatment area 
2 = Moderate 
Fine scaling generalized to all areas of the treatment area 
3 = Severe 
Scaling and peeling of skin over all areas of the treatment area 
 
Subjective Irritation Parameters 
 
Burning/stinging 
0 = None 
No burning/stinging of the treatment area 
1 = Mild 
Slight burning/stinging sensation of the treatment area; not really bothersome 
2 = Moderate 
Definite warm, burning/stinging of the treatment area that is somewhat bothersome 
3 = Severe 
Hot burning/marked stinging sensation of the treatment area that causes definite 
discomfort and may interrupt daily activities and/or sleep 


GALDERMA LABORATORIES, L.P.  
 
CONFIDENTIAL 
Protocol GLI.04.SPR.US10354 
 
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Page 9 of 15 
 
 
4.3.5 
Digital Images (Clinic Day Assessments: Baseline, Week 6, Week 12, and Week 24) 
 
Prior to photography procedures, clinic personnel will ensure that subjects have a clean face with no makeup as 
described in the study procedures. Subjects will remove any jewelry from the area(s) to be photographed and 
equilibrate for at least 15 minutes to ambient conditions (68-75ºF and 35-65% humidity) within the clinic before any 
photographs are taken. 
 
VISIA Imaging: 
 
Subjects will be provided with a black or gray matte headband to keep hair away from the face and instructed on 
proper headband placement. Subjects will be provided with a black matte shirt or a black or gray matte cloth will be 
draped over the subjects’ clothing. Subjects will be instructed to adopt neutral, non-smiling expressions with their 
eyes gently closed. Subjects will be carefully positioned for each photograph, for the center, right, and left side 
views.  
 
Full-face digital images will be taken of each subject (right side, left side, and center views) using the VISIA CR 
photo-station (Canfield Imaging Systems, Fairfield, New Jersey) with a Canon Mark II 5D or 6D digital SLR camera 
(Canon Incorporated, Tokyo, Japan) under the following lighting conditions:     
Standard lighting 1 
Standard lighting 2 
Cross-polarized 
Parallel polarized 
UV fluorescence 
 
Visible Light Imaging (Beauty shot) 
 
For subjects completing at sites 1 and 2 (Stephens’ Texas and Colorado locations), digital images will be taken of 
each subject’s face using visible light. Full-face images will be taken of each subject’s center view. Subjects will not 
be wearing any headband or using any headrest/chinrest. Subjects will be instructed to adopt neutral, non-smiling 
expressions with their eyes open. 
 
4.3.6 
Self-Assessment Questionnaires (Clinic Day Assessment: Baseline, Week 1, Week 2, Week 6, Week 
12, and Week 24) 
 
Subjects will be asked to complete a self-assessment questionnaire.  This questionnaire has a 5-point Likert 
Response Scale (1=Strongly Agree; 5=Strongly Disagree).  Responses for each item will be transformed into percent 
agreement (percentage of subjects with a score of 1 or 2) and presented descriptively.  The individual items will be 
asked at the indicated time points: 
 
Questions 
Visit 2: 
Week 1 
Visit 3: 
Week 2 
Visit 4: 
Week 6 
Visit 
5: 
Week 12 
Visit 
7: 
Week 24 
I experienced noticeable improvement in my skin 
tone 
  
  
  
X 
X 
I experienced noticeable improvement in my skin 
texture 
  
  
  
X 
X 
I experienced noticeable improvement in my skin 
radiance 
  
  
  
X 
X 
My skin has a more youthful appearance 
  
  
  
X 
X 
My skin is clearer skin using this treatment 
  
X 
X 
X 
X 
I feel my skin is now clear 
  
  
X 
X 
X 
This treatment works faster than my previous acne 
treatment. 
X 
X 
  
  
  
This treatment is strong enough to give me clear, 
acne free skin. 
  
  
  
X 
X 
The treatment helped to reduce redness and 
inflammation caused by my acne. 
  
  
X 
X 
X 
I feel that this treatment deep cleans and unblocks 
my pores. 
X 
X 
X 
  
  


GALDERMA LABORATORIES, L.P.  
 
CONFIDENTIAL 
Protocol GLI.04.SPR.US10354 
 
SAP Date:  22 April 2016 Version 1.0 
 
Page 10 of 15 
 
This treatment visually minimized my pore size. 
  
  
X 
X 
X 
I noticed an improvement in my acne. Strongly 
agree to Strongly disagree 
X 
X 
  
  
X 
This treatment reduces my acne without leaving 
behind dry, flakey skin. 
  
  
X 
X 
X 
I have noticed I had fewer breakouts than my 
previous treatments.                                                     X 
X 
X 
X 
X 
My skin looks better than before 
  
  
X 
X 
X 
This treatment breaks my cycle of acne and keeps 
my skin clear                                                    
  
  
  
X 
X 
I saw improvement in the overall health of my skin 
since starting the regimen     
X 
  
X 
X 
X 
My skin looks noticeably smoother and healthier 
  
  
X 
X 
  
The areas of my skin where I used to have acne is 
now clear and radiant after daily treatment.                 
  
X 
X 
X 
X 
I feel better about my skin  since I’ve started the 
treatment regimen 
  
  
X 
X 
X 
I feel more confident since I’ve started the 
treatment 
  
  
X 
X 
X 
Has your quality of life improved now that you 
have started using this product? 
  
  
  
X 
X 
I would continue using this treatment beyond 24 
weeks as a regular part of my skincare routine. 
  
  
  
  
X 
What is your overall satisfaction with the regimen? 
  
  
X 
X 
X 
I have noticed a positive difference in the 
appearance of my skin with this regimen. 
  
  
X 
X 
X 
This once a day regimen is easy to use every day. 
X 
  
X 
  
  
I liked the feel of this product. 
X 
  
  
  
I would recommend this product to others. 
  
  
  
X 
X 
My acne is as clear as if I went to a doctor or 
received a prescription. 
  
  
  
X 
X 
I don’t feel the need for a prescription after using 
this product. 
  
  
  
X 
X 
Total: 
7 
6 
16 
24 
25 
 
5 
Sample Size  
 
Approximately 130 subjects will be enrolled to complete with 100 subjects (50 per cell). For the purposes of this 
protocol, enrolled is defined as a subject who has been consented, screened and eligibility has been verified. Each 
site is to enroll no more than 40 subjects, with at least 100 subjects expected to complete when combined.  
Sample size is determined according to Sponsor’s recommendation.  
6 
General Considerations 
 
6.1 
Timing of Analyses 
 
The final analysis will be performed after all subjects exit from the study. 
 
6.2 
Analysis Populations 
 
All statistical analyses will be performed based on the following subject populations. Data from the 4 sites will be 
pool together prior to the statistical analysis. 
 
 


GALDERMA LABORATORIES, L.P.  
 
CONFIDENTIAL 
Protocol GLI.04.SPR.US10354 
 
SAP Date:  22 April 2016 Version 1.0 
 
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6.2.1 
Intent-to-Treat (ITT) Population 
 
The ITT population is defined as all subjects who are randomized and have at least one post-treatment administration 
evaluation. This is the primary population for efficacy analyses. All primary efficacy variables and secondary 
efficacy variables will be analyzed based on the ITT population. LOCF (Last Observation Carried Forward) will be 
used to impute missing efficacy data for this population. 
 
6.2.2 
Safety Population 
 
The safety population is defined as all subjects who are enrolled and receive at least one dose of study product. In 
practice, only the subjects who return their study product unopened will be excluded from the safety population. 
Safety variables will be analyzed based on the safety population. 
 
6.3 
Missing Data 
 
If there are missing post-baseline data of primary and secondary variables for the ITT population, these data will be 
imputed using the LOCF method.  
 For the safety population, all evaluable data obtained will be used.  No imputation will be carried forward for the 
missing data.  In addition, missing last used date will be imputed using the last visit date and the missing first used 
date will be imputed using the baseline date.  
 
6.4 
Interim Analyses and Data Monitoring 
 
Interim analyses will be performed after Week 1, 2, 6 and 12 visit. No other interim analyses will be conducted. 
 
The conduct of the study will be closely monitored by representatives of GLLP following GCP, ICH guidelines, 
applicable SOPs, regulatory guidelines and all local regulations. The clinical investigation will be monitored to 
ensure that:  the rights and well-being of the subjects are protected; the reported data are accurate, complete and 
verifiable from applicable source documents; and the study is conducted in accordance with the currently approved 
protocol and any other study agreements, GCP, and all applicable regulatory requirements. The investigator will 
allow the GLLP representatives to have access to all study records, CRF, corresponding subject medical records, and 
any other documents considered source documentation. The investigator also agrees to assist the representatives, if 
required, which can include AE reporting.  
 
7 
Summary of Study Data 
 
The subject disposition, demographics, baseline characteristics, compliance (number of missed applications, total 
number of applications, etc.), visit dates including informed consent date, inclusion/exclusion criteria, previous 
therapies and concomitant therapies by treatment will be listed or summarized. All primary and safety variables 
listed will be summarized at each visit. The categorical variables will be summarized by frequency and percentage 
for each response category (N, %). The continuous variables will be summarized using means, medians, minimum, 
maximum, and standard deviations (SD) for each visit.  
Additional summary tables will be provided for AEs that are considered serious (SAEs), related to the study product, 
and AEs leading to discontinuation. All AE summary tables are based on the number of subjects in safety population 
who have experienced AE(s). For a given AE, a subject will be counted once, even if he or she has experienced 
multiple episodes for that particular AE. 
 
7.1 
Subject Disposition 
 
The summary will be produced in accordance with section 12. 
 
7.2 
Protocol Deviations 
 
The summary will be produced in accordance with section 12. 
 
7.3 
Demographic and Baseline Variables 
 
The following demographic parameters will be captured at the screening visit: 
 Age 
 Gender  
 Ethnicity and Race (subject self-identified) 
 Fitzpatrick Skin Type Classification 


GALDERMA LABORATORIES, L.P.  
 
CONFIDENTIAL 
Protocol GLI.04.SPR.US10354 
 
SAP Date:  22 April 2016 Version 1.0 
 
Page 12 of 15 
 
 
The summary will be produced in accordance with section 12.  
 
7.4 
Medical History and Current Medical Condition 
 
A listing of medical history and current medical condition will be provided. 
 
7.5 
Prior and Concomitant Medications/Therapies 
 
A listing of prior and concomitant medications/therapies will be provided. 
 
7.6 
Treatment Compliance 
 
Compliance will be assessed from subjects’ daily diary where test material applications will be recorded. Subjects 
will be considered compliant with the treatment product if they use at least 80% of the expected applications for each 
of the test product during participation in the study. Subjects will be considered non-compliant if usage is over 
120%. The percent dosing compliant subjects received (= number of product use recorded in diary / number of 
excepted application*100%) of each subject will be reported in a data listing.  The percent dosing compliant subjects 
received will be summarized. The number and percent of subjects who take 80-120% of the expected applications 
will also be reported. 
 
8 
Efficacy Analyses 
 
8.1 
Lesion Count, Investigator’s Global Assessment (IGA), Clinical Grading of tolerance parameters and 
Clinical Grading of Efficacy Parameters through Digital Images 
 
A descriptive statistical summary will be provided. The descriptive statistical summary includes the number of 
observations (N), mean, median, standard deviation (SD), minimum (MIN) and maximum (MAX) of scores/values 
at all applicable time points. Mean of the change from baseline (defined as post-baseline value minus baseline value) 
will be estimated at post-baseline time points. The null hypothesis, that the mean change from baseline is zero, will 
be tested.  Wilcoxon signed-rank test will be employed. 
The following will be calculated and reported for each evaluation parameter at the applicable post-baseline time 
point(s):  
 
Percent mean change from baseline = 
(visit mean score – baseline mean score) x 100 
baseline mean score 
 
Percent of subjects improved/worsened = 
(number of subjects improved/worsened from baseline) x 100 
total number of subjects 
 
For applicable parameters, comparisons between the treatment cells will be made in terms of changes from baseline. 
The null hypothesis, that the mean change from baseline is equal between the 2 treatment cells at post-baseline time 
points, will be tested using a Wilcoxon rank sum test. 
 
Each of the following lesions will be analyzed separately for forehead, left cheek, chin, right cheek, and the total of 4 
areas as global face: 
 Inflammatory acne lesions (sum of papules and pustules) 
 Non-inflammatory acne lesions (sum of open comedones and closed comedones) 
 Total lesion counts (sum of inflammatory and non-inflammatory acne lesions counts 
 
8.2 
Subject Satisfaction Questionnaire 
 
For Subject Satisfaction Questionnaire data, a tabulation including frequency and percentage of all response options 
will be reported for each question. In addition, frequency and percentage of agree (combining “Strongly Agree” and 
“Agree”), neutral (“Neither Agree nor Disagree”) and disagree (combining “Strongly Disagree” and “Disagree”) will 
also be reported for each question. A binomial (sign) test will be performed to test if the proportion of the combined 
agree responses is equal to the combined disagree responses for each applicable question. For applicable questions, 
responses will also be compared between treatments by Fisher’s exact test. The test null hypothesis is that the 
proportion of the combined agree responses is equal between treatment cells. A more appropriate analysis may be 
performed based on the questionnaire design, which will be recorded in a note to file and in the study report.  
 


GALDERMA LABORATORIES, L.P.  
 
CONFIDENTIAL 
Protocol GLI.04.SPR.US10354 
 
SAP Date:  22 April 2016 Version 1.0 
 
Page 13 of 15 
 
9 
Safety Analyses 
 
9.1 
Adverse Events, Serious Adverse Events and other Significant Adverse Events 
 
Adverse events will be summarized.  A listing of adverse events will be provided. 
Additional summary tables will be provided for AEs that are considered serious (SAEs), related to the study product, 
and AEs leading to discontinuation. All AE summary tables are based on the number of subjects who have 
experienced AE(s). For a given AE, a subject will be counted once, even if he or she has experienced multiple 
episodes for that particular AE. 
 
9.2 
Pregnancies 
 
Pregnancy test will be performed at screening and week 24/early exit. These data will not be statistically analysed. 
 
10 
Reporting Conventions 
 
 
All statistics will be reported to one decimal place unless specified.  
 
All statistical tests will be 2-sided at significance level alpha=0.05. P-values will be reported to 3 decimal 
places (0.000).  P-values less than 0.001 will be displayed as <0.001. 
 
11 
Technical Details 
 
SAS software version 9.30 or later ((SAS Statistical Institute).) will be used to statistically analyze the data and 
all output will be in Excel formats. 
 
12 
Listing of Tables, Listings and Figures 
 
The data will not be presented in Figures for this study. 
 
The following listings will be made and submitted along with the final report: 
 
Subject Demographics and Disposition 
 
Subject Compliance (individual responses to product usage compliance query at applicable visits, subject’s 
visit dates, Informed Consent and Inclusion/Exclusion tables) 
 
Concomitant Medications/ Therapies 
 
Subject’s Medical History (including medical and surgical procedures) 
 
Adverse Events 
 
All efficacy and tolerability endpoints: lesion count, Investigator’s global assessment (IGA), clinical 
grading of tolerance parameters, clinical grading of efficacy parameters through digital images, and subject 
satisfaction questionnaire 
 
Protocol deviations  
 
The listings will contain a minimum of the following: 
 
Title 
 
Footnotes (if any) 
 
Population 
 
Endpoint(s) 
 
Time Points  
 
Summary statistics 


GALDERMA LABORATORIES, L.P.  
 
CONFIDENTIAL 
Protocol GLI.04.SPR.US10354 
 
SAP Date:  22 April 2016 Version 1.0 
 
Page 14 of 15 
 
 
The following is a partially complete example of listing of tables: 
Table Title 
Population 
Endpoint 
Time 
Points 
Summary 
Statistics 
Formal 
Analysis 
Foot 
Notes 
Subject 
Demographics 
All enrolled 
Age, Gender, 
Ethnicity and Race, 
Fitzpatrick Skin 
Type 
Screening 
N, Mean, 
SD, Median, 
Min-Max, 
Percent 
NA 
 
Subject Disposition 
All enrolled 
Disposition 
Screening, 
Baseline-
Week 24 
NA 
NA 
 
Individual responses 
to product usage 
compliance query 
All enrolled 
N (%) of dosing 
compliant subjects 
Week 1 - 
Week 24 
N, Percent 
NA 
 
Subject’s visit dates 
All enrolled 
All visits 
Screening, 
Baseline – 
Week 24 
NA 
NA 
 
Informed Consent 
All enrolled 
Date of signature 
Screening 
NA 
NA 
 
Inclusion/Exclusion 
All enrolled 
Inclusion Criteria 
and Exclusion 
Criteria 
Screening 
NA 
NA 
 
Concomitant 
Medications/ 
Therapies 
All enrolled 
Medication, Dose 
and units, 
Frequency, Route, 
Indication, start and 
stop date, Ongoing 
or not, relation to 
AE 
Screening, 
Baseline – 
Week 24 
NA 
NA 
 
Subject’s Medical 
History (including 
medical and surgical 
procedures) 
All enrolled 
Condition/surgery/ 
procedure and 
start/stop dates 
Screening 
NA 
NA 
 
Urine Pregnancy test 
All enrolled 
Date, 
positive/negative 
Screening 
and week 
24 
NA 
NA 
 
Lesion count 
ITT 
Number of open 
comedones, closed 
comedones, 
papules, and 
pustules on 
forehead, left 
cheek, chin and 
right cheek on each 
subject’s face 
Screening, 
Baseline – 
Week 24 
(except 
week 18)  
Summary of  
N, Mean, 
SD, Median, 
Min-Max, 
change from 
baseline 
statistics, 
treatment 
comparisons 
NA 
 
Investigator’s 
Global Assessment 
ITT 
Investigator’s 
global assessment 
of acne severity 
Screening, 
Baseline – 
Week 24 
(except 
week 18)   
Summary of  
N, Mean, 
SD, Median, 
Min-Max, a 
change from 
baseline 
statistics, 
treatment 
comparisons 
NA 
 
Clinical Grading of 
Tolerance 
Parameters 
ITT 
Erythema, dryness, 
scaling, 
burning/stinging  
Screening, 
Baseline – 
Week 24 
(except 
week 18)   
Summary of  
N, Mean, 
SD, Median, 
Min-Max, 
change from 
baseline 
statistics, 
treatment 
NA 
 


GALDERMA LABORATORIES, L.P.  
 
CONFIDENTIAL 
Protocol GLI.04.SPR.US10354 
 
SAP Date:  22 April 2016 Version 1.0 
 
Page 15 of 15 
 
Table Title 
Population 
Endpoint 
Time 
Points 
Summary 
Statistics 
Formal 
Analysis 
Foot 
Notes 
comparisons 
Clinical Grading of 
Efficacy Parameters 
through Digital 
Images 
ITT 
Lines/wrinkles (if 
present), skin 
texture, skin tone 
evenness, clarity, 
and overall skin 
complexion 
Baseline, 
Week 6, 
Week 12, 
and Week 
24 
Summary of  
N, Mean, 
SD, 
Median, 
Min-Max, 
change from 
baseline 
statistics, 
treatment 
comparisons 
NA 
 
Digital Imaging 
ITT 
N/A 
Baseline, 
Week 6, 
Week 12, 
and Week 
24 
NA 
Stephens 
will not 
perform 
image 
analysis 
 
Self-Assessment 
Questionnaire 
ITT 
Self-Assessment 
Questionnaire 
Week1 – 
Week 24 
N, Percent, 
sign test, 
treatment 
comparisons 
NA 
 
Adverse Events 
Safety 
Description of 
event, start and stop 
date, Frequency, 
Severity, 
Relationship to test 
product, Action 
taken, Treatment 
and Final outcome 
Baseline – 
Week 24 
NA 
NA 
 
 
13 
References 
1. U.S. Food and Drug Administration. Guidance for industry: acne vulgaris: developing drugs for treatment. 
September 2005. http://www.fda.gov. 
2. Shai, A., Maibach, HI, Baran, R. Baran.  Acne in Handbook of Cosmetic skin Care. Publisher Martin Duntiz 
Ltd., Chapter 9, 81-100, 2001. 
3. Rizer, RL, Mills, OH, Trookman, NS. The assessment of acne: a re-evaluation of grading strategies. 
Scientific Poster, Annual Meeting of the Am. Acad. Dermatol (2001). 
4. Griffiths CE, Wang TS, Hamilton TA, Voorhees JJ, Ellis CN. A photonumeric scale for the assessment of 
cutaneous photodamage. Arch Dermatol. 1992 Mar;128(3):347-351.