Clinical trial NCT03170388
Conditions: Acne Vulgaris
Sponsor: Bausch Health Americas, Inc.
Start date: 2017-10-05; Completion date: 2019-04-23
Enrollment: 741 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris

Detailed description:
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris

Arms: arm 1: Gel arm 2: Component A arm 3: Component B arm 4: Component C arm 5: Vehicle Gel
Interventions: intervention 1: IDP-126 Gel intervention 2: IDP-126 Component A intervention 3: IDP-126 Component B intervention 4: IDP-126 Component C intervention 5: IDP-126 Vehicle Gel
Intervention descriptions: intervention 1: Gel intervention 2: Component A intervention 3: Component B intervention 4: Component C intervention 5: Vehicle Gel

Protocol documents:
Prot_SAP_000.pdf: 
CLINICAL STUDY PROTOCOL 
IDP-126 
Protocol V01-126A-201 
A Phase 2, Multicenter, Randomized, Double-Blind, 
Vehicle-Controlled, Parallel-Group, Clinical Study Comparing the 
Efficacy and Safety of IDP-126 Gel in the Treatment of  
Acne Vulgaris 
Development Phase: 
2 
Study Design: 
Multicenter, randomized, double-blind, vehicle-controlled efficacy 
and safety study 
Date: 
22 August 2017 (Amendment 2) 
01 August 2017 (Amendment 1) 
30 May 2017 
Sponsor: 
Dow Pharmaceutical Sciences, a Division of Valeant 
Pharmaceuticals North America, LLC 
1330 Redwood Way, Suite C 
Petaluma, CA 94954 
707-793-2600
CONFIDENTIAL 
Nothing herein is to be disclosed without prior approval of the sponsor. 
NCT03170388




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Personnel Responsible for Conducting the Study 
 
A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 
Parallel-Group Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel  
in the Treatment of Acne Vulgaris 
 
Contract Research Organization / Medical Monitor 


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Principal Investigator Protocol Agreement Page 
I agree: 
• To assume responsibility for the proper conduct of this clinical study at this study 
center and to conduct the study in compliance with this protocol, any future 
amendments, and with any other study conduct procedures provided by the sponsor. 
• That I am aware of, and will comply with, the internationally recognized code of Good 
Clinical Practices (GCP) and all other applicable regulatory requirements to obtain 
written and dated approval from the Institutional Review Board (IRB) or Independent 
Ethics Committee (IEC) for the study protocol, written informed consent, consent form 
updates, subject-recruitment procedures (eg, advertisements), and any other written 
information to be provided to the subjects, before initiating this clinical study. 
• Not to implement any changes to, or deviations from the protocol without prior 
agreement from the sponsor and review and documented approval from the IRB/IEC, 
except to eliminate an immediate hazard to the study subjects, or when change(s) 
involves only logistical or administrative aspects of the clinical study. 
• To permit direct monitoring and auditing by the sponsor or sponsor’s representatives 
and inspection by the appropriate regulatory authority(ies). 
• That I am thoroughly familiar with the appropriate use of the study drugs(s), as 
described in this protocol, and any other information provided by the sponsor or 
designee, including, but not limited to, the current Investigator Brochure or equivalent 
document and approved product label (if applicable). 
• To provide sufficient time, and adequate numbers of qualified staff and facilities for the 
foreseen duration of the clinical study to conduct the study properly, ethically, and 
safely. 
• To ensure that all persons assisting in this study are adequately informed about the 
protocol, study drug(s), and their clinical study-related duties and functions. 
 
 
 
 
Principal Investigator (print name) 
 
 
 
 
Principal Investigator (signature) 
 
Date 
 


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2 Synopsis 
Name of Sponsor/Company: Dow Pharmaceutical Sciences, a division of Valeant Pharmaceuticals North 
America, LLC 
Name of Investigational Product: IDP-126 Gel 
Name of Active Ingredients: Fixed combination of clindamycin phosphate 1.2%, benzoyl peroxide 
(BPO)  3.1%, and adapalene 0.15% 
Title of Study: A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group 
Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris 
Number of Clinical Centers: Multicenter, approximately 35 study centers in North America 
Objective:  
The primary objective of this study is to compare the efficacy, safety and tolerability of IDP-126 Gel in 
subjects with moderate to severe acne vulgaris. The safety and efficacy of once daily application of 
IDP-126 Gel will be compared to IDP-126 Component A, IDP-126 Component B, IDP-126 Component C 
and IDP-126 Vehicle Gel. 
Methodology:  
This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the 
safety, tolerability, and efficacy of IDP-126 Gel in comparison with IDP-126 Component A, IDP-126 
Component B,  IDP-126 Component C and IDP-126 Vehicle Gel at Weeks 2, 4, 8, and 12. To be eligible 
for the study, subjects must be at least 9 years of age and have a clinical diagnosis of moderate to severe 
acne (defined as an Evaluator’s Global Severity Score [EGSS] of 3 or 4), presenting with 30-100 
inflammatory facial lesions (papules, pustules, and nodules), 35-150 non-inflammatory facial lesions 
(open and closed comedones), and ≤ 2 facial nodules.      
All subjects will receive once daily, topically applied treatment to the face for 12 weeks. Subject visits 
include Screening, Baseline, Week 2, Week 4, Week 8, and Week 12, at which safety and efficacy 
assessments will be conducted (Screening and Baseline may occur on the same day if no washout is 
required). One pump of study drug will be dispensed to the subjects at the Baseline, Week 4, and Week 8 
study visits. Subjects will be evaluated for drug usage compliance at each post baseline study visit (Weeks 
2, 4, 8, and 12). Subjects will apply their treatments at home, once daily (in the evening), as instructed by 
the study coordinator or designee at each study center.  
The investigator will assess the subject’s face at each study visit. Information on reported and observed 
AEs will be obtained at each visit. An abbreviated physical examination and vital sign measurements will 
be performed at Baseline and Week 12 (end of study) for all subjects. Blood samples will be collected 
from subjects at Baseline and Week 12, for CBC/Diff and serum chemistry. For all female subjects of 
childbearing potential (FOCBP), urine pregnancy testing will be performed at Screening, Baseline (prior 
to randomization), and at Weeks 2, 4, 8, and 12. Additionally, serum pregnancy testing will be performed 
at Baseline and Week 12. 
In addition, at selected study centers, standardized photography of the face will be performed at Baseline, 
and Weeks 4, 8 and 12. 
Number of subjects planned:  
Approximately 750 subjects will be randomized in a1:1:1:1:1 ratio to the following treatment groups: 
• 
150 Subjects to IDP-126 Gel (clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15%) 
• 
150 Subjects to IDP-126 Component A (BPO 3.1%/adapalene 0.15%) 
• 
150 Subjects to IDP-126 Component B (clindamycin phosphate 1.2%/BPO 3.1%) 
• 
150 Subjects to IDP-126 Component C (clindamycin phosphate 1.2%/adapalene 0.15%) 
• 
150 Subjects to IDP-126 Vehicle Gel 
 
 


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Inclusion criteria:  
1. Male or female at least 9 years of age and older. 
2. Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an 
assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches 
age of consent during the study they should be re-consented at the next study visit). 
3. Subject must have an EGSS of 3 (moderate) or 4 (severe) at the baseline visit. 
4. Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 
30, but no more than 100. 
5. Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 
35, but no more than 150. 
6. Subjects with 2 or fewer facial nodules. 
7. FOCBP and females who are premenses must be willing to practice effective contraception for the 
duration of the study. (Effective contraception is defined as stabilized on oral contraceptive for at least 
3 months, intrauterine device, condom with spermicide, diaphragm with spermicide, implant, 
NuvaRing®, injection, transdermal patch or abstinence.) Females on birth control pills must have 
taken the same type pill for at least 3 months prior to entering the study and must not change type 
during the study. Those who have used birth control pills in the past must have discontinued usage at 
least 3 months prior to the start of the study. Women who use birth control for acne control only 
should be excluded. 
8. Premenses females and FOCBP must have a negative urine pregnancy test at Screening Visit, and a 
negative urine pregnancy test at Baseline Visit.  
9. Subjects must be willing to comply with study instructions and return to the clinic for required visits. 
Subjects under the age of consent must be accompanied by the parent or legal guardian at the time of 
assent/consent signing. 
10. If a cleanser, moisturizer or sunscreen is needed during the study, subjects must be willing to use only 
allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products (see 
Appendix 17.2). The subject must agree to use non-comedogenic products (including makeup and 
shaving products).  
Exclusion Criteria: 
1. Use of an investigational drug or device within 30 days of enrollment or participation in a research 
study concurrent with this study. 
2. Any dermatological conditions on the face that could interfere with clinical evaluations such as acne 
conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, 
gram-negative folliculitis, dermatitis, eczema. 
3. Any underlying disease(s) or some other dermatological condition of the face that requires the use of 
interfering topical or systemic therapy or makes evaluations and lesion count inconclusive. 
4. Subjects with a facial beard or mustache that could interfere with the study assessments. 
5. Subjects with more than 2 facial nodules. 
6. Evidence or history of cosmetic-related acne. 
7. Subject has a history of experiencing significant burning or stinging when applying any facial 
treatment (eg, makeup, soap, masks, washes, sunscreens, etc) to their face. 
8. Female subjects who are pregnant, nursing mothers, planning a pregnancy during the course of the 
study, or become pregnant during the study. 
9. Use of estrogens (eg, Depogen, Depo-Testadiol, Gynogen, Valergen, etc) for less than 12 weeks 
immediately preceding study entry; subjects treated with estrogens 12 or more consecutive weeks 
immediately prior to study entry need not be excluded unless the subject expects to change dose, drug 
or discontinue estrogen use during the study. 
10. If female, subject has a history of hirsutism, polycystic ovarian disease or clinically significant 
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11. History of regional enteritis, ulcerative colitis, inflammatory bowel disease, pseudomembranous 
colitis, chronic or recurrent diarrhea, or antibiotic-associated colitis.  
12. Treatment of any type of cancer within the last 6 months, with the exception of complete surgical 
excision of skin cancer outside the treatment area.  
13. Subject uses medications and/or vitamins during the study which are reported to exacerbate acne 
(azathioprine, haloperidol, Vitamin D, Vitamin B12, halogens such as iodides or bromides, lithium, 
systemic or topical mid-to super-high potency corticosteroids on the treatment area, phenytoin and 
phenobarbital). Multivitamins, including Vitamin A, at recommended daily doses and Vitamin D at 
stable doses, are acceptable. 
14. History of hypersensitivity or allergic reactions to any of the study preparations as described in the 
Investigator’s Brochure, including known sensitivities to any dosage form of clindamycin phosphate, 
BPO, or adapalene. 
15. Concomitant use of potentially irritating over-the-counter products that contain ingredients such as 
BPO, alpha-hydroxy acid, salicylic acid, retinol or glycolic acids. 
16. Subjects who have not undergone the specified washout period(s) for the following topical 
preparations or physical treatments used on the face or subjects who require the concurrent use of any 
of the following in the treatment area: 
 
 
 
 
 
 
 
 
 
 
 
If the subject requires topical treatment for acne on areas other than the face (eg, chest and/or back), 
the investigator may prescribe a product that does not contain clindamycin phosphate, BPO, or 
adapalene, and must be noted in the source documents and the electronic case report form (eCRF).  
17. Subjects who have not undergone the specified washout period(s) for the following systemic 
medications or subjects who require the concurrent use of any of the following systemic medications: 
Corticosteroids (including intramuscular injections)  
    (inhaled corticosteroids allowed)  
4 weeks 
Antibiotics 
4 weeks 
Other systemic acne treatments 
4 weeks 
Systemic retinoids 
6 months 
18. Subject intends to use a tanning booth or sunbathe during the study. 
19. Subjects who are unable to communicate or cooperate with the investigator due to language problems, 
poor mental development, or impaired cerebral function. 
20. Subjects with any underlying disease that the investigator deems uncontrolled, and poses a concern 
for the subject’s safety while participating in the study. 
- 
Topical astringents and abrasives (including comedone 
removal strips) on the face 
1 week 
- 
Non-allowed moisturizers or sunscreens on the face 
1 week 
- 
Antibiotics on the face 
2 weeks 
- 
Other topical anti-acne drugs on the face  
2 weeks 
- 
Soaps containing antimicrobials on the face  
2 weeks 
- 
Anti-inflammatory agents and corticosteroids on the face 
4 weeks 
- 
Retinoids, including retinol on the face  
4 weeks 
- 
Facial procedures, including chemical peel, 
microdermabrasion, light (PDT, LED) and laser therapy, and 
acne surgery  
4 weeks 
Investigational product, dosage and mode of administration:  
Investigational Product: IDP-126 Gel (clindamycin phosphate 1.2%, BPO 3.1%, and adapalene 0.15%), 
applied topically to the face once daily for 12 weeks.  
Duration of treatment:  
12 weeks for all subjects. 
 
 


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Reference therapy, dosage and mode of administration:  
• IDP-126 Component A (BPO 3.1%/adapalene 0.15%) applied once daily for 12 weeks. 
• IDP-126 Component B (clindamycin phosphate 1.2%/BPO 3.1%) applied once daily for 12 weeks. 
• IDP-126 Component C (clindamycin phosphate 1.2%/adapalene 0.15%) applied once daily for 12 
weeks.  
• IDP-126 Vehicle Gel applied once daily for 12 weeks. 
Criteria for evaluation: 
Primary efficacy: 
The co-primary efficacy endpoints are intended to compare the numerical superiority of once daily 
application of IDP-126 Gel with IDP-126 Vehicle Gel and each of the gel components (Components A, B 
and C). Specifically, the endpoints to be summarized using descriptive and inferential statistics are: 
(1) Absolute change from Baseline to Week 12 in mean inflammatory lesion counts. 
(2) Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts.  
(3) Percent of subjects who achieve at least a 2-grade reduction from baseline and are “clear” or 
“almost clear” at Week 12 based on the Evaluator’s Global Severity Score (EGSS). 
Secondary efficacy: 
The secondary efficacy endpoints are intended to compare the numerical superiority of once daily 
application of IDP-126 Gel with IDP-126 Vehicle Gel and each of the gel components (Components A, B 
and C). Specifically, the secondary endpoints to be summarized using descriptive statistics are: 
(1) Absolute change in inflammatory and non-inflammatory lesion counts from baseline at Weeks 2, 
4, and 8. 
(2) Percent of subjects who achieve at least a 2-grade reduction from baseline and are “clear” or 
“almost clear” at Week 2, 4, and 8 based on the EGSS. 
(3) Mean percent change in inflammatory and non-inflammatory lesion counts from baseline at 
Weeks 2, 4, 8, and 12. 
Efficacy Measurements: 
Lesion Counts 
At each visit, the evaluator will count the total number of inflammatory lesions (papules, pustules, and 
nodules) on the subject’s face. Nodules will be counted separately, but will be included in the total 
inflammatory lesion count. At baseline, eligible subjects may have no more than 2 nodules. Nodules will 
be included in the statistical analysis of inflammatory lesion counts. All inflammatory lesions will be 
counted at the same time rather than counting papules and pustules separately. The evaluator will also 
count the total number of non-inflammatory lesions (open and closed comedones). The same blinded 
evaluator should perform the lesion counts and EGSS evaluations at all visits from baseline to week 12 for 
the same subject.  
Inflammatory lesions are defined as follows: 
Papule – a small, solid elevation less than 5 mm in diameter. Most of the lesion is above the surface of the 
skin.  
Pustule – a small, circumscribed elevation less than 5 mm in diameter that contains yellow-white exudate. 
Nodule – a subcutaneous lesion greater than or equal to 5 mm in diameter. 
Non-inflammatory lesions are defined as follows: 
Open comedones (black head) – a lesion in which the follicle opening is widely dilated with the contents 
protruding out onto the surface of the skin. 
Closed comedones (white head) – a lesion in which the follicle opening is closed, but the sebaceous gland 
is enlarged by the pressure of the sebum build up, which in turn causes the skin around the follicle to thin 
and become elevated with a white appearance. 


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Evaluator’s Global Severity Score (EGSS) 
At each visit, the severity will be determined based on evaluator-blinded evaluations of the signs and 
symptoms of acne vulgaris. Every effort should be made to have the same evaluator assess the same 
subject at each visit. If this is not possible, the same evaluator should assess the subject at both the 
Baseline and Week 12 visits. Evaluations will be scored on a scale of 0-4, with 0 being clear and 4 being 
severe. Please see the table below for complete definitions. The EGSS should always be completed prior 
to the lesion counts. 
Score 
Grade 
Description 
0 
Clear 
Normal, clear skin with no evidence of acne vulgaris 
1 
Almost clear 
Rare non-inflammatory lesions present, with rare non-inflamed papules (papules must 
be resolving and may be hyperpigmented, though not pink-red) 
2 
Mild 
Some non-inflammatory lesions are present, with few inflammatory lesions 
(papules/pustules only; no nodulocystic lesions) 
3 
Moderate 
Non-inflammatory lesions predominate, with multiple inflammatory lesions evident: 
several to many comedones and papules/pustules, and there may or may not be 
1 nodulocystic lesion 
4 
Severe 
Inflammatory lesions are more apparent, many comedones and papules/pustules, there 
may or may not be up to 2 nodulocystic lesions 
 
Safety Measurements: 
Safety evaluations will include the following: 
- 
The percent of subjects who experience a cutaneous reaction (erythema, scaling, 
hypo/hyper-pigmentation, itching, burning, or stinging) graded at a level of 3 at any point in the 
study following the first application of study drug. 
- 
The percent of subjects who experience a cutaneous adverse event (AE) irrespective of severity 
grade at any point in the study following the first application of study drug. 
- 
Changes from baseline in all safety laboratory values and vital sign measurements as summarized 
using descriptive statistics by treatment group and study visit. 
- 
Subjects will be assessed for the occurrence of new and ongoing AEs.  
Cutaneous safety and tolerability will be evaluated by tabulations of AEs and Cutaneous Safety and 
Tolerability Evaluation scores (scaling, erythema, hypo/hyper-pigmentation, itching, burning, and 
stinging) to be assessed at each study visit.  Itching, burning and stinging (cutaneous tolerability) will be 
reviewed with the subject at each study visit as an average over the period since the previous visit. 
Scaling, erythema, and hypo/hyper-pigmentation (cutaneous safety) will be assessed by the evaluator at 
each visit. Cutaneous tolerability signs and symptoms that result in the subject requiring a concomitant 
therapy, interruption of treatment, or discontinuation from the study will be reported as an AE. 
Statistical Methods 
All statistical processing will be performed using SAS® version 9.3 or later unless otherwise stated. 
Statistical significance will be based on two-tailed tests of the null hypothesis resulting in p-values of 0.05 
or less. P-values for selected variables will be presented to assist the reviewer in evaluating the outcome of 
the study. Failure to achieve a statistically significant result at an alpha level of 0.05 does not imply a 
failed study. 
The absolute change in mean inflammatory and non-inflammatory lesion counts from baseline to Week 12 
will be analyzed with an analysis of covariance (ANCOVA) with factors of treatment group and analysis 
center and a covariate of their respective baseline lesion count. A non-parametric analysis may be used. 
Additionally, 4 pairwise tests will be conducted comparing the IDP-126 Gel to IDP-126 Vehicle Gel and 
IDP-126 Gel to each of the dual component gels. 
The percent of subjects with treatment success, defined as at least a 2-grade improvement from baseline in 
the EGSS and an EGSS equating to “clear” or “almost clear”, will be analyzed with a logistic regression 
test with factors of treatment group and analysis center and a covariate of baseline severity at Week 12. 
Four pairwise tests will be conducted comparing the IDP-126 Gel to IDP-126 Vehicle Gel and IDP-126 


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Gel to each of the dual component gels.  
The primary method of handling missing efficacy data will be MCMC multiple imputation. Other 
methods, as well as the MCMC imputation, will be specified in the statistical analysis plan which will be 
finalized prior to data base lock. 
Populations Analyzed and Treatment Groups: 
Inflammatory and non-inflammatory lesion counts will be recorded for each subject at baseline and at 
Weeks 2, 4, 8, and 12. The absolute and percent change from baseline in inflammatory and non-
inflammatory lesions will be derived for each subject at Weeks 2, 4, 8, and 12.  
The EGSS will be recorded for each subject. The EGSS will be dichotomized into “success” and “failure” 
with a subject considered a success if the EGSS at Weeks 2, 4, 8, and 12 is at least 2 grades less than 
baseline and achieving “clear” or “almost clear.”  
An intent-to-treat (ITT) analysis will be conducted on all study subjects. The ITT population will consist 
of all randomized subjects who received study drug. 
The safety population will consist of all randomized subjects who are presumed to have used the study 
drug at least once and who provide at least 1 post-baseline evaluation. A per-protocol (PP) analysis will 
also be conducted. Subjects will be eligible for the PP analysis if they complete the 12-week evaluation 
without noteworthy study protocol violations (i.e., any subject or investigator activity that could have 
possibly interfered with the therapeutic administration of the treatment or the precise evaluation of 
treatment efficacy). The PP population will include subjects in the ITT population who do not meet any of 
the following criteria: 
• Failed any of the inclusion/exclusion criteria. 
• Have taken any interfering concomitant medications. 
• Did not attend the Week 12 visit, with the exception of a discontinuation from the study due to an AE 
related to study treatment or documented lack of treatment effect. 
• Missed more than 1 post baseline study visit prior to Week 12 
• Have not been compliant with the dosing regimen (i.e., subjects may not miss more than 5 
consecutive days of dosing and must take 80%-120% of expected doses). The number of expected 
doses will be determined for each subject based on the length of their participation in the study. 
• Out of visit window at the Week 12 visit. 
Prior to breaking the blind, other additional criteria may be added to the list to accommodate for 
unforeseen events that occurred during the conduct of the trial that result in noteworthy study protocol 
violations. Subject demographic and baseline characteristics will be summarized by treatment group using 
descriptive statistics for the ITT, PP, and safety analysis sets. 
Efficacy Evaluation: 
Primary: 
Co-primary efficacy analyses of the absolute change in inflammatory and in non-inflammatory lesions, 
from baseline, will be conducted on the ITT population. The pre-specified time point will be Week 12. 
Descriptive statistics will be presented by treatment group for inflammatory and for non-inflammatory 
lesions as well as the absolute change in inflammatory and in non-inflammatory lesions. All of the testing 
relating to the analysis of inflammatory and non-inflammatory lesions will use the methods introduced in 
Section 12 of the protocol. 
The co-primary analysis of the dichotomized EGSS (success being at least a 2-grade improvement and 
achieving “clear” or “almost clear”) for the ITT population will be based on the logistic regression test 
with factors of treatment group and analysis center and a covariate of baseline severity. 
Secondary:  
Mean percent change in inflammatory and non-inflammatory lesion counts from baseline, as well as 
proportion of subjects with at least a 2-grade improvement in the EGSS from baseline, will be evaluated at 


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Weeks 2, 4, 8, and 12. 
Safety Evaluation: 
All subjects who receive medication and provide at least 1 post-baseline evaluation will constitute the 
safety population. Safety will be evaluated by tabulations of AEs, Cutaneous Safety and Tolerability 
Evaluations, vital signs/abbreviated physical examinations, and safety laboratory results.  
Cutaneous Safety and Tolerability Evaluation scores (erythema, scaling, hypo/hyper-pigmentation, 
itching, burning, and stinging) will be presented with descriptive statistics at baseline and at Weeks 2, 4, 8, 
and 12 for each treatment group. Frequencies and percentages for each outcome category will be included 
in these statistics. Mean values will be presented graphically by week and treatment group. 
Vital sign measurements, an abbreviated physical examination, and safety laboratory results will be 
conducted on all subjects at specified visits. For pre-menses females and FOCBP, urine pregnancy and 
serum pregnancy testing will occur at specified visits. Changes from baseline in safety laboratory values 
and vital sign measurements will be summarized with descriptive statistics for each treatment group at all 
applicable study visits. Shift tables will be presented for changes in safety laboratory values to summarize 
laboratory test results collected at Baseline and Week 12. Normal ranges established by the central 
laboratory will be used to determine the shifts. A listing of all out-of-range laboratory test results at any 
assessment time point will also be provided.  
Determination of clinical significance for all out-of-range laboratory values will be made by each 
investigator and included in the listing. In addition, a listing of all clinically significant laboratory test 
results will be provided.  
All previous concomitant medications will be classified based on terminology from the World Health 
Organization Drug Dictionary. Previous therapies and concomitant medications data will be presented in 
the data listings. 
All AEs occurring during the study will be recorded and classified using the Medical Dictionary for 
Regulatory Activities (MedDRA) terminology. Descriptions of AEs will include the date of onset, the date 
the AE ended, the severity of the AE, the relationship to study drug, the action taken regarding study drug 
usage, the action taken to treat the AE, and the outcome. Adverse events will be summarized by treatment 
group and severity. Each subject will be counted only once within a system organ class or a preferred term 
by using the AEs with the highest severity within each category. 
Adverse events will be summarized by treatment group and relationship to study drug. Each subject will 
be counted only once within a system organ class or a preferred term by using the AEs with the greatest 
relationship within each category. 
All information pertaining to AEs noted during the study will be listed by subject, detailing the verbatim 
descriptions given by the investigator, preferred term, system organ class, start date, stop date, severity, 
actions taken, and drug relatedness. The AE onset will also be shown relative (in number of days) to the 
day of initial dose of the randomized study drug. 
Serious adverse events (SAEs) will be tabulated by subject within treatment groups. In addition, a list of 
subjects who discontinued from the study and a list of subjects who experienced SAEs will also be 
provided. 
 
 


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Subject Self-Assessments 
Subjects will be asked to complete an Acne-Specific Quality of Life Questionnaire during the study. The 
Investigator assessments (EGSS and lesion counts) will be conducted independently of this subject self-
assessment. Inferential statistical analysis will not be performed on the questionnaire; the subjective 
responses will be compared between treatment groups for trends.  
 
This study will be performed in compliance with Good Clinical Practice including the archiving of 
essential study documents. This protocol follows guidelines outlined by the International Conference for 
Harmonisation. All data furnished to the investigator and his/her staff, and all data obtained through this 
stud, will be regarded as confidential and proprietary in nature and will not be disclosed to any third party, 
except for the United States Food and Drug Administration or other regulatory body, without written 
consent from the sponsor. 


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3 Table of Contents 
1 
TITLE PAGE ...........................................................................................................1 
2 
SYNOPSIS ...............................................................................................................5 
3 
TABLE OF CONTENTS .......................................................................................13 
4 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ........................17 
5 
INTRODUCTION .................................................................................................18 
6 
STUDY OBJECTIVES AND PURPOSE .............................................................20 
7 
INVESTIGATIONAL PLAN ................................................................................20 
7.1 
Overall Study Design and Plan: Description .............................................20 
8 
SELECTION AND WITHDRAWAL OF SUBJECTS .........................................23 
8.1 
Subject Inclusion Criteria ..........................................................................23 
8.2 
Subject Exclusion Criteria .........................................................................23 
8.3 
Subject Withdrawal Criteria ......................................................................25 
9 
TREATMENT PLAN ............................................................................................27 
9.1 
Methods of Assigning Subjects to Treatment Groups ...............................27 
9.2 
Randomization and Blinding .....................................................................27 
9.3 
Unblinding .................................................................................................27 
9.4 
Prior and Prohibited Concomitant Medication or Therapy........................28 
9.5 
Treatment Compliance ...............................................................................29 
9.6 
Protocol Deviations and Violations ...........................................................29 
10 
STUDY DRUG MATERIALS AND MANAGEMENT ......................................30 
10.1 
IDP-126 Gel, IDP-126 Component A, B and C Gel, and IDP-126 Vehicle 
Gel ..............................................................................................................30 
10.1.1 Packaging and Labeling .................................................................31 
10.1.2 Storage, Handling, and Disposal of Study Drug ............................32 
10.1.3 Administration ...............................................................................32 
10.2 
Study Drug Accountability ........................................................................33 
11 
STUDY PROCEDURES AND EVALUATIONS ................................................34 
11.1 
Schedule of Evaluations and Procedures ...................................................34 
11.1.1 Visit 1: Screening Visit (Day −35 to Day 0) .................................34 
11.1.2 Visit 2: Baseline Visit (Day 0) .......................................................35 
11.1.3 Visit 3: Week 2 (Day 14 ± 3 Days) Visit .......................................36 
11.1.4 Visit 4: Week 4 (Day 28 ± 3 Days) Visit .......................................37 
11.1.5 Visit 5: Week 8 (Day 56 ± 3 Days) Visit .......................................38 
11.1.6 Visit 6: Week 12 (Day 84 -3/+5 Days) Visit – End of Study Visit39 


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11.2 
Evaluation of Efficacy ...............................................................................40 
11.2.1 Evaluator’s Global Severity Score .................................................40 
11.2.2 Lesion Counts ................................................................................41 
11.2.3 Other Assessments .........................................................................41 
11.3 
Evaluation of Safety ...................................................................................41 
11.3.1 Cutaneous Safety Evaluations ........................................................41 
11.3.2 Tolerability Evaluations .................................................................42 
11.3.3 Medical History and Abbreviated Physical Examination ..............43 
11.3.4 Laboratory Tests ............................................................................43 
11.3.5 Pregnancy Tests .............................................................................43 
11.4 
Adverse Events ..........................................................................................43 
11.4.1 Definition of Adverse Event ..........................................................43 
11.4.2 Documenting Adverse Experiences ...............................................44 
11.4.3 Serious Adverse Events .................................................................44 
11.4.4 Assessment of Severity ..................................................................45 
11.4.5 Assessment of Causality ................................................................45 
11.4.6 Reporting of Serious Adverse Events ............................................46 
11.4.7 Expedited Serious Adverse Event Reports ....................................47 
11.4.8 Pregnancy .......................................................................................47 
12 
STATISTICS .........................................................................................................48 
12.1 
Assessment of Efficacy ..............................................................................48 
12.1.1 Primary Efficacy ............................................................................49 
12.1.2 Secondary Efficacy ........................................................................49 
12.1.3 Test of Superiority for Lesion Count Variables Evaluator's Global 
Severity Score ................................................................................49 
12.1.4 Statistical Hypothesis Testing and Control of Multiplicity ...........50 
12.1.5 Descriptive Statistics ......................................................................50 
12.1.6 Missing Efficacy Data Imputations ...............................................50 
12.2 
Assessment of Safety .................................................................................53 
12.2.1 Adverse Events ..............................................................................53 
12.2.2 Safety Laboratory Tests .................................................................53 
12.2.3 Vital Sign Measurements ...............................................................54 
12.2.4 Concomitant Medications ..............................................................54 
12.2.5 Subject Self-Assessments ..............................................................54 
12.3 
Subject Disposition ....................................................................................54 
12.4 
Demographics and Baseline Characteristics ..............................................54 
12.5 
Protocol Deviations ....................................................................................54 
12.6 
Compliance ................................................................................................54 


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12.7 
Interim Analyses ........................................................................................54 
12.8 
Additional Statistical Considerations .........................................................55 
12.8.1 Analysis Sets ..................................................................................55 
12.8.2 Sample Size Determination............................................................56 
12.8.3 Handling of Missing Data ..............................................................56 
12.8.4 Multicenter Issues ..........................................................................56 
12.8.5 Multiplicity Issues ..........................................................................58 
12.8.6 Windowing Rules...........................................................................58 
13 
QUALITY CONTROL AND QUALITY ASSURANCE .....................................58 
13.1 
Study Monitoring .......................................................................................58 
13.2 
Audits and Inspections ...............................................................................58 
13.3 
Data Quality Assurance .............................................................................59 
14 
ETHICS AND ADMINISTRATIVE ISSUES ......................................................59 
14.1 
Ethical Conduct of the Study .....................................................................59 
14.2 
Ethics Review ............................................................................................59 
14.3 
Written Informed Consent/Assent .............................................................59 
14.4 
Subject Data Protection..............................................................................60 
14.5 
Data Monitoring Committee ......................................................................60 
14.6 
Financial Disclosure...................................................................................60 
14.7 
Investigator Obligations .............................................................................60 
14.8 
Changes to the Protocol .............................................................................61 
14.9 
Confidentiality/Publication of the Study ...................................................61 
15 
DATA HANDLING AND RECORD KEEPING .................................................61 
15.1 
Inspection of Records ................................................................................61 
15.2 
Retention of Records..................................................................................62 
16 
REFERENCES ......................................................................................................63 
17 
APPENDICES .......................................................................................................65 
17.1 
Subject Instruction Sheet ...........................................................................65 
17.2 
Cleansers, Moisturizers and Sunscreen Use Guidelines ............................67 
17.3 
Acne-Specific Quality of Life Questionnaire (Acne-QoL) .......................68 
 
 
 
 


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LIST OF TABLES 
Table 1. 
Study Design and Schedule of Assessments ..................................................22 
Table 2. 
Drug Substances Identification .......................................................................30 
Table 3. 
Study Drug Identification ...............................................................................31 
Table 4. 
Evaluator’s Global Severity Score ..................................................................40 
 


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4 List of Abbreviations and Definitions of Terms 
Abbreviation or Specialist Term 
Definition or Explanation 
AE 
Adverse event 
BPO 
Benzoyl peroxide 
cGCP 
Current Good Clinical Practice 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
eCRF 
Electronic case report form 
EGSS 
Evaluator’s Global Severity Score 
ET 
Early termination 
FDA 
United States Food and Drug Administration 
FOCBP 
Female of Childbearing Potential  
G 
Gram 
GCP 
Good Clinical Practice 
ICH 
International Conference for Harmonisation 
IEC 
Independent Ethics Committee 
IRB 
Institutional Review Board 
ITT 
Intent-to-treat  
IWRS 
Interactive Web Response System 
LED 
Light Emitting Diode 
MedDRA 
Medical Dictionary for Regulatory Affairs 
OTC 
Over-the-counter 
PDT 
Photodynamic Therapy 
PP 
Per protocol 
QoL 
Quality of Life 
SAE 
Serious adverse event 
UPT 
Urine Pregnancy Test 
WHO 
World Health Organization 
 
In this protocol, “sponsor duties” refer to responsibilities that will be performed by the 
sponsor, the sponsor’s designee, or the sponsor’s designated contract research organization 
(CRO). In this protocol, “investigator” refers to the principal investigator or his/her designee, 
who is responsible for performing the study procedures and assessments. 


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5 Introduction 
Acne is a very common disorder of sebaceous follicles that is most prevalent among 
teenagers, usually triggered by the increase in androgen production occurring at puberty 
(Krakowski 2008). Although acne generally resolves by the age of 25, approximately 3% to 
8% of adults 25 to 44 years of age present with acne (Goodman 2006, White 1998). The 
pathogenesis is complex and appears to involve 4 primary features: stimulation of sebum 
gland activity, bacterial proliferation (especially Propionibacterium acnes), abnormal 
follicular hyperkeratinization and resultant obstruction of the sebaceous follicles, and the 
release of inflammatory mediators (Thiboutot 2009). These changes in acne patients result in 
the formation of clinical inflammatory lesions including superficial pustules such as 
comedones (popularly known as “blackheads” or “whiteheads”) and more deeply located 
papules, nodules, and cysts (Krakowski 2008). The areas most affected by the disease include 
the pilosebaceous follicles of the head and upper trunk, where the sebaceous glands are 
particularly active (Webster 2002). 
Given the complexity of the pathogenic mechanisms that lead to acne, for maximum 
efficacy, consensus guidelines recommend the use of combination therapy consisting of 
medications with different, but complementary, mechanisms of action (Thiboutot 2009). In 
particular, the guidelines advocate the use of a retinoid and an antibiotic (eg, clindamycin 
phosphate) or antibacterial (eg, benzoyl peroxide [BPO]) as first-line and maintenance 
therapy in patients with both inflammatory and non-inflammatory lesions (Ghali 2009, 
Thiboutot 2009).  
Although antibiotics like clindamycin were among the first effective treatments for acne, 
recent acne management guidelines discourage the use of antibiotics as monotherapy due to 
the development of bacterial resistance (Nast 2012, Thiboutot 2009). The guidelines also 
recommend limiting both the frequency and duration of antibiotic use for acne, and to use 
antibiotics in conjunction with BPO to minimize the development of resistance at sites of 
application (Thiboutot 2009). Topically applied BPO is keratolytic, comedolytic, and 
anti-inflammatory, and has bactericidal activity against Propionibacterium acnes (Gollnick 
2003, Harper 2010, Tanghetti 2009). To date, there is no evidence of P acnes resistance to 
BPO (Harper 2010). Further, the combination of BPO with chemical structures that contain a 
tertiary amine within their structure, such as clindamycin, increases the generation of BPO 
radicals and thereby creates a real biologic synergism (Burkhart 2008) that contributes to 
their complementary effects on acne pathogenesis. 
Retinoids (eg, adapalene, tretinoin, tazarotene) are anticomedogenic, anti-inflammatory, and 
inhibit microcomedone formation (Ghali 2009, Zaenglein 2008). Topical, daily retinoid 
monotherapy is used to inhibit the formation of comedones and usually clear even severe 
comedonal acne within a few months (Shalita 2001). Adapalene, a synthetic retinoid, is a 


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naphthoic acid derivative with retinoid-like properties. In the cell, adapalene can bind 
specifically to retinoic acid nuclear (and not cytosolic) receptors to exert its effects 
(Zaenglein 2008). Biochemical and pharmacological profile studies have demonstrated that 
adapalene is a modulator of cellular differentiation, keratinization, and inflammatory 
processes (Piskin 2007). Topical formulations of adapalene have been used to treat acne in 
the United States (US) for more than 20 years. 
Retinoids have also been paired with antibiotic/BPO fixed-dose combination products 
(Bowman 2005, Del Rosso 2007, Kircik 2007, Tanghetti 2006) and, consistently across 
studies of these products, regimens that included a topical retinoid were more effective than 
regimens that did not (Thiboutot 2009). Adapalene (0.1% gel and cream formulations) has a 
lower irritation potential relative to other retinoids (Dosik 2005a, Dosik 2005b) and is 
therefore well suited for use in combination topical regimens, particularly those containing 
BPO, which is also potentially irritating (Del Rosso 2007).  
Thus, treatment with a combination of topical clindamycin phosphate, BPO, and adapalene 
can be expected to provide optimal overlapping benefits for maximal efficacy: each of these 
agents has some degree of anti-inflammatory activity; both the antibiotic and BPO decrease 
P acnes proliferation (Weiss 2004); BPO is also keratolytic (Harper 2010); and adapalene 
additionally regulates keratinization (Zaenglein 2008).  
A fixed-dose combination treatment is optimal to enhance patient adherence due to 
simplified application regimens (eg, once daily versus sequential morning/evening 
administration of each active agent) and also to preclude substance incompatibilities due to 
application errors (eg, oxidation by using incompatible single agents) (Thielitz 2013). Of 
note, when an adapalene 0.1% gel and a clindamycin 1.2%/BPO 5% fixed-dose combination 
gel were combined in equal amounts by weight, there was no resultant instability of any of 
the active components for up to 24 hours (Bikowski 2006).  
The current study is intended to evaluate the safety and efficacy of IDP-126 Gel, a novel 
fixed-dose combination of clindamycin phosphate, BPO, and adapalene (1.2%/3.1%/0.15%), 
relative to its vehicle and dual component combinations (BPO/Adapalene,clindamycin/BPO 
and clindamycin/adapalene) for the treatment of acne vulgaris in subjects 9 years of age and 
older. 
 
 


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6 Study Objectives and Purpose  
The objective of this study is to evaluate the efficacy, safety and tolerability of once daily 
application of IDP-126 Gel compared with each of its dual components (IDP-126 Component 
A Gel, IDP-126 Component B Gel and IDP-126 Component C Gel) and vehicle (IDP-126 
Vehicle Gel) in subjects with moderate to severe acne vulgaris.  
7 Investigational Plan 
7.1 
Overall Study Design and Plan: Description 
This is a multicenter, randomized, double-blind, vehicle-controlled, parallel-group study 
designed to assess the safety, efficacy and tolerability of IDP-126 Gel in comparison with its 
gel components and vehicle gel. To be eligible for the study, subjects must be at least 9 years 
of age or older, and have a clinical diagnosis of moderate to severe acne vulgaris (a score of 
3 or 4 [moderate to severe] on the Evaluator’s Global Severity Scale [EGSS]), presenting 
with 30-100 inflammatory facial lesions (papules, pustules, and nodules), 35-150 non-
inflammatory facial lesions (open and closed comedones), and ≤ 2 facial nodules.  
Approximately 750 subjects will be enrolled into this study and randomized into 1 of 
5 treatment groups in a 1:1:1:1:1 ratio:  
• 150 subjects to receive IDP-126 Gel, once daily application 
• 150 subjects to receive IDP-126 Component A Gel, once daily application 
• 150 subjects to receive IDP-126 Component B Gel, once daily application 
• 150 subjects to receive IDP-126 Component C Gel, once daily application 
• 150 subjects to receive IDP-126 Vehicle Gel, once daily application 
Subjects will be enrolled at approximately 35 independent study centers. The duration of 
treatment will be 12 weeks. Subjects will be evaluated at Screening, Baseline, and at 
subsequent follow-up visits (Weeks 2, 4, 8, and 12). 
An interactive web based response system (IWRS) will be employed to facilitate 
randomization of study subjects. Treatment assignments and study drug kit numbers will be 
generated centrally by the IWRS. At each study center, subject numbers will be assigned 
consecutively at the Screening visit, starting with 001. 
The assigned study drug will be applied topically to the face once daily at home, in the 
evening, for 12 weeks (up to the evening prior to the Week 12 visit), with the exception of 
study visit days (Baseline, Week 2, 4 and 8) where study drug will be applied (also by the 
subject) after the study visit is completed, at the investigational center. The initial application 
will be done at the investigational center as per instruction from the study coordinator or 


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designee. The subjects will be instructed to avoid exposure to direct sunlight in order to 
prevent sunburn. Use of sunscreens with at least a sun protection factor (SPF) of 15 and 
protective clothing (eg, a hat) is recommended when exposure cannot be avoided. Subjects 
will apply their daily treatments at home as explained by the study coordinator or designee at 
each study center. During post baseline study visits (Weeks 2, 4, 8 and 12), the subjects will 
be asked to return their used pumps of study drug and will be dispensed new pumps of study 
drug (new pumps dispensed on Weeks 4 and 8 only; Week 2 will have no new study drug 
dispensed; and Week 12 will be final visit). During the study, each subject will only be 
permitted to use approved, non-medicated cleansers, moisturizers, and sunscreens. 
During the study, subjects will be asked to complete the Acne-Specific Quality of Life 
questionnaire (Acne-QoL, Appendix 17.3). The Investigator assessments (EGSS, lesion 
counts) will be conducted independently of this subject self-assessment. The EGSS should be 
completed prior to the lesion counts.  The Acne-QoL questionnaire will be completed at 
Baseline and Week 12. Inferential statistical analyses will not be performed on the 
questionnaire; the subjective responses will be compared between treatment groups for 
trends. Information on reported and observed adverse events (AEs) will be obtained at each 
visit. An abbreviated physical examination, along with vital sign measurements, will be 
performed at Baseline and Week 12 (end of study, final visit) for all subjects. 
Blood samples will be collected from subjects at Baseline and Week 12 for CBC/Diff and 
serum chemistry.  For all female subjects of childbearing potential (FOCBP), urine 
pregnancy testing will be performed at Screening, confirmed at prior to randomization at 
Baseline, and then repeated at Weeks 2, 4, 8 and 12. Serum pregnancy test will also be 
conducted at Baseline and Week 12. 
Subjects who terminate their study participation early will be asked to complete all Week 12 
assessments, as appropriate. Subjects who discontinue from the study during the treatment 
period will not be replaced. 


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Table 1. 
Study Design and Schedule of Assessments 
PROCEDURES 
VISIT 1a 
Screening Visit 
(Day -35 to 0) 
VISIT 2 
Baseline 
Day 0 
VISIT 3 
Week 2 
(Day 14 ±3 days) 
VISIT 4 
Week 4 
(Day 28 ±3 days) 
VISIT 5 
Week 8 
(Day 56 ± 3 days) 
VISIT 6b 
Week 12  
(Day 84 -3/+5 days) 
Informed Consent/Assent 
X 
 
 
 
 
 
Obtain Subject Number from IWRS 
X 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
Medical Historyc 
X 
X 
 
 
 
 
Inclusion/Exclusion Criteriac 
X 
X 
 
 
 
 
Previous Therapiesc 
X 
X 
 
 
 
 
Acne-QoL 
 
X 
 
 
 
X 
Pregnancy Test (pre-menses and FOCBP)d 
X 
X 
X 
X 
X 
X 
Abbreviated Physical Examinationc,e 
X 
X 
 
 
 
X 
Vital Sign Measurementsc  
X 
X 
 
 
 
X 
Safety Labs (CBC/Diff, serum chemistry) 
 
X 
 
 
 
X 
EGSS 
X 
X 
X 
X 
X 
X 
Lesion Counts 
X 
X 
X 
X 
X 
X 
Photographs (select study centers only) 
 
X 
 
X 
X 
X 
Cutaneous Safety Evaluation 
 
X 
X 
X 
X 
X 
Tolerability Evaluation 
 
X 
X 
X 
X 
X 
Randomization in IWRS (obtain kit #) 
 
X 
 
X 
X 
 
Administer Subject Instructions (see Appendix 17.1) 
 
X 
 
 
 
 
Dispense Study Drug  
 
X 
 
X 
X 
 
Weigh Study Drug  
 
X 
X 
X 
X 
X 
Study Drug Applied at Study Center 
 
X 
X 
X 
X 
 
Study Drug Collected 
 
 
 
X 
X 
X 
Subject Diary Calendar Dispensed 
 
X 
X 
X 
X 
 
Subject Compliance Reviewed / Diary Reviewed 
 
 
X 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 
X 
X 
Concomitant and Prohibited Therapies/Medication 
Review  
X 
X 
X 
X 
X 
X 
End of Study 
 
 
 
 
 
X 
a If no washout is needed, Visits 1 and 2 may occur on the same day. If a washout is needed, Visit 2 must occur after the appropriate washout period. 
b All Week 12 procedures must be completed for all subjects who terminate early 
c Update at Baseline visit prior to randomization.  
d For pre-menses females and FOCBP, the urine pregnancy test must be completed at all scheduled visits. Serum pregnancy testing will be completed at Baseline and Week 12 only. Subjects with a positive pregnancy test 
at any time during the study will be discontinued.  
e Height will be measured at Screening only; weight measurements and examinations of other abbreviated physical parameters will be performed at Baseline and Week 12.


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8 Selection and Withdrawal of Subjects 
8.1 
Subject Inclusion Criteria 
Subjects meeting all of the following criteria will be eligible for study entry: 
1. Male or female at least 9 years of age and older. 
2. Written and verbal informed consent must be obtained. Subjects less than age of 
consent must sign an assent for the study and a parent or a legal guardian must sign 
the informed consent (if subject reaches age of consent during the study they should 
be re-consented at the next study visit). 
3. Subject must have an EGSS of 3 (moderate) or 4 (severe) at the baseline visit. 
4. Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) 
count no less than 30, but no more than 100. 
5. Subjects with a facial acne non-inflammatory lesion (open and closed comedones) 
count no less than 35, but no more than 150. 
6. Subjects with 2 or fewer facial nodules. 
7. FOCBP1 and females who are premenses must be willing to practice effective 
contraception for the duration of the study. (Effective contraception is defined as 
stabilized on oral contraceptive for at least 3 months, intrauterine device, condom 
with spermicide, diaphragm with spermicide, implant, NuvaRing®, injection, 
transdermal patch or abstinence.) Females on birth control pills must have taken the 
same type pill for at least 3 months prior to entering the study and must not change 
type during the study. Those who have used birth control pills in the past must have 
discontinued usage at least 3 months prior to the start of the study. Women who use 
birth control for acne control only should be excluded. 
8. Premenses females and FOCBP must have a negative urine pregnancy test2 at the 
Screening Visit, and a negative urine pregnancy test at the Baseline Visit.  
9. Subjects must be willing to comply with study instructions and return to the clinic for 
required visits. Subjects under the age of consent must be accompanied by the parent 
or legal guardian at the time of assent/consent signing. 
10. If a cleanser, moisturizer or sunscreen is needed during the study, subjects must be 
willing to use only allowed cleansers, moisturizers, sunscreens, or 
moisturizer/sunscreen combination products (see Appendix 17.2). The subject must 
agree to use non-comedogenic products (including makeup and shaving products).  
8.2 
Subject Exclusion Criteria 
                                                 
1 Premenses females and FOCBP include any female who has not undergone successful surgical sterilization 
(hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea 
> 12 consecutive months; or women on hormone replacement therapy with documented plasma follicle-stimulating 
hormone level > 35mLU/mL). Even women who are using oral, implanted or, injectable contraceptive hormones, an 
intrauterine device, barrier methods (diaphragm, condoms, spermicidal) to prevent pregnancy, practicing abstinence 
or where partner is sterile (eg, vasectomy), should be considered to be of child bearing potential.           
2   Urine pregnancy tests must have a minimum sensitivity of 25mIU HCG/mL of urine and must be performed 
within 72 hours prior to the start of study drug. Kits will be provided by the CRO/designee. 


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Subjects meeting any of the following criteria will be excluded from the study: 
1. Use of an investigational drug or device within 30 days of enrollment or participation 
in a research study concurrent with this study. 
2. Any dermatological conditions on the face that could interfere with clinical 
evaluations such as acne conglobata, acne fulminans, secondary acne, perioral 
dermatitis, clinically significant rosacea, Gram-negative folliculitis, dermatitis, 
eczema. 
3. Any underlying disease(s) or some other dermatological condition of the face that 
requires the use of interfering topical or systemic therapy or makes evaluations and 
lesion count inconclusive. 
4. Subjects with a facial beard or mustache that could interfere with the study 
assessments. 
5. Subjects with more than two (2) facial nodules. 
6. Evidence or history of cosmetic-related acne. 
7. Subject has a history of experiencing significant burning or stinging when applying 
any facial treatment (eg, makeup, soap, masks, washes, sunscreens, etc) to their face. 
8. Female subjects who are pregnant, nursing mothers, planning a pregnancy during the 
course of the study, or become pregnant during the study. 
9. Use of estrogens (eg, Depogen, Depo-Testadiol, Gynogen, Valergen, etc) for less than 
12 weeks immediately preceding study entry; subjects treated with estrogens 12 or 
more consecutive weeks immediately prior to study entry need not be excluded unless 
the subject expects to change dose, drug or discontinue estrogen use during the study. 
10. If female, subject has a history of hirsutism, polycystic ovarian disease or clinically 
significant menstrual irregularities. 
11. History of regional enteritis, ulcerative colitis, inflammatory bowel disease, 
pseudomembranous colitis, chronic or recurrent diarrhea, or antibiotic-associated 
colitis.  
12. Treatment of any type of cancer within the last 6 months, with the exception of 
complete surgical excision of skin cancer outside the treatment area.  
13. Subject uses medications and/or vitamins during the study which are reported to 
exacerbate acne (azathioprine, haloperidol, Vitamin D, Vitamin B12, halogens such 
as iodides or bromides, lithium, systemic or topical mid-to super-high potency 
corticosteroids on the treatment area, phenytoin and phenobarbital). Multivitamins, 
including Vitamin A, at recommended daily doses, and Vitamin D at stable doses, are 
acceptable. 
14. History of hypersensitivity or allergic reactions to any of the study preparations as 
described in the Investigator’s Brochure, including known sensitivities to any dosage 
form of clindamycin phosphate, BPO, or adapalene. 
15. Concomitant use of potentially irritating over-the-counter products that contain 
ingredients such as BPO, alpha-hydroxy acid, salicylic acid, retinol or glycolic acids. 


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16. Subjects who have not undergone the specified washout period(s) for the following 
topical preparations or physical treatments used on the face or subjects who require 
the concurrent use of any of the following in the treatment area: 
 
     
 
 
 
 
 
 
 
 
 
 
 
If the subject requires topical treatment for acne on areas other than the face (eg, chest 
and/or back), the investigator may prescribe a product that does not contain 
clindamycin phosphate, BPO, or adapalene and must be noted in the source 
documents and the electronic case report form (eCRF). 
17. Subjects who have not undergone the specified washout period(s) for the following 
systemic medications or subjects who require the concurrent use of any of the 
following systemic medications: 
 
Corticosteroids (including intramuscular injections) 
    (inhaled corticosteroids are allowed)  
4 weeks 
Antibiotics 
4 weeks 
Other systemic acne treatments 
4 weeks 
Systemic retinoids 
6 months 
 
18. Subject intends to use a tanning booth or sunbathe during the study. 
19. Subjects who are unable to communicate or cooperate with the investigator due to 
language problems, poor mental development, or impaired cerebral function. 
20. Subjects with any underlying disease that the investigator deems uncontrolled, and 
poses a concern for the subject’s safety while participating in the study. 
8.3 
Subject Withdrawal Criteria 
Reasons for withdrawal may include, but are not limited to, the following: 
• Acne flare, as determined by the investigator, which requires treatment with a 
disallowed therapy. 
• Either at the investigator's request, for tolerability reasons (eg, severe adverse 
reactions), or at the subject’s request. 
• When the requirements of the protocol are not followed. 
Topical astringents and abrasives (including comedone 
removal strips) on the face 
1 week 
Non-allowed moisturizers or sunscreens on the face  
1 week 
Antibiotics on the face  
2 weeks 
Other topical anti-acne drugs on the face  
2 weeks 
Soaps containing antimicrobials on the face 
2 weeks 
Anti-inflammatory agents and corticosteroids on the face  
4 weeks 
Retinoids, including retinol on the face  
4 weeks 
Facial procedures, including chemical peel, 
microdermabrasion, light (PDT, LED) and laser therapy, and 
acne surgery  
4 weeks 


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• When a concomitant therapy likely to interfere with the results of the study is 
reported or required by the subject (the investigators will report all such information 
on the source documents/eCRFs and decide, in accordance with the Sponsor, whether 
the subject is to be withdrawn). 
• When a subject is lost to follow-up. The investigators will try twice to reach the 
subject by telephone, email and/or text message, and will send a follow-up letter by 
certified mail before considering that the subject is lost to follow-up. These actions 
will be reported on the End of Study source documents and the final eCRF and a copy 
of the follow-up letter will be maintained in the investigator’s file. 
All premature discontinuations and their associated reasons must be carefully documented by the 
investigator on source documents and the final eCRF, and, if need be, on the AE form. In any 
case, no subject who has been included and has an assigned study number can be replaced by 
another if the subject discontinues prematurely for whatever reason. All data gathered on the 
subject prior to termination will be made available to the Sponsor. 
Reasons for study completion/discontinuation as listed on the final report form are defined as 
follows: 
Normal Study Completion – Subject completes the study as planned in the protocol. 
Adverse Event – Complete an AE form. 
Death – Complete a serious adverse event (SAE) form. 
Subject Request – Consent withdrawal, subject moved, schedule conflicts. 
Protocol Violation – Contact the Sponsor or designee before making decision. 
Lost to Follow-Up – Document with 2 phone calls, emails and/or text messages, and a 
certified letter. 
Pregnancy – Subject will discontinue study drug immediately, but will be followed to term. 
Complete a pregnancy form. 
Worsening Condition – Subject requires alternate treatment for acne before the end of the 
study and the investigator determines it is not due to lack of efficacy. 
Lack of Efficacy – Subject requires alternate treatment for acne after at least 2 weeks of 
study drug treatment and the risk of continuing the subject in the study outweighs the benefit 
as determined by the investigator. 
Withdrawal by Parent/Guardian – An indication that the study participant has been 
removed from the study by the parent or legal guardian; includes consent withdrawal, subject 
moves, schedule conflicts, etc. 
Study Terminated by Sponsor – An indication that a clinical study was stopped by its 
Sponsor. 
Other – Specify in the comments section of the eCRF. 


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Subjects who terminate study drug early will be asked to complete all Week 12 assessments and 
procedures prior to commencement of any alternative therapy for acne (if possible). Subjects 
who discontinue from the study during the treatment period will not be replaced. 
All subjects are free to withdraw from participating in this study at any time and for whatever 
reason, specified or unspecified, and without prejudice. No constraints will be placed on ordinary 
subject management, and subjects, when appropriate, will be placed on other conventional 
therapy upon request or whenever clinically necessary as determined by their physician. 
9 Treatment Plan 
9.1 
Methods of Assigning Subjects to Treatment Groups 
This is a double-blind study in which the identity of the study drug will be unknown to the 
investigator/evaluator and all subjects, as well as all individuals closely associated with the 
study. 
Eligible subjects will be randomized to 1 of the 5 study drug groups in a ratio of 1:1:1:1:1 
(IDP-126 Gel : IDP-126 Component A Gel : IDP-126 Component B Gel : IDP-126 Component 
C Gel: IDP-126 Vehicle Gel).  
The study center will assign each screened subject a unique 6-digit study subject number. The 
number will consist of the 3-digit study center number (pre-assigned by Sponsor/designee) and 
the 3-digit chronological screening number, starting with 001 (eg, 101001, 101002). The IWRS 
will assign the study drug kit to subjects based on a randomization code; the kit will be dispensed 
to the subjects at Baseline and Weeks 4 and 8 by the study center staff. A study drug log will 
document the inventory, dispensing, and collecting of study drug at each study center. 
9.2 
Randomization and Blinding 
The study drugs will be packaged and labeled identically, and the study drug kits will be 
numbered sequentially and dispensed randomly to the subjects entering the study within each 
study center. Study drug supplies will be distributed to the study centers to maintain the 
randomization ratio within each study center.  
As a double-blind study, the investigators/evaluators, the study center staff, the Sponsor, and the 
clinical monitors will not be aware of the treatment assigned to the individual study subjects. 
Delegated staff members at each study center will dispense the study drugs and will collect all 
used and unused study drug pumps as scheduled. 
9.3 
Unblinding  
The treatment assignments for all enrolled subjects will be unblinded only after the conclusion of 
the study. Specifically, the blind will be broken only after all data are verified, entered into the 
database, and validated; subject evaluability assessments are performed and entered into the 
database; and the database is locked. 


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In the case of a medical emergency, the investigator can break the blind for the subject involved, 
preferably by first discussing the situation with the medical monitor and the Sponsor (or 
designee) immediately. After confirmation, the investigator will be contacted with unblinding 
information by a Sponsor representative or via IWRS. The investigator will record the code 
break in the subject’s source documents. 
9.4 
Prior and Prohibited Concomitant Medication or Therapy 
Any concomitant medication or therapy stopped for washout as indicated below is to be 
recorded. As noted in the exclusion criteria, there are mandatory washout periods and restrictions 
during the study for the following topical treatments or physical treatments on the face that have 
a known beneficial effect for acne vulgaris: 
Topical astringents and abrasives (including 
comedone removal strips) on the face 
1 week 
Non-allowed moisturizers or sunscreens on the face 1 week 
Antibiotics on the face 
2 weeks 
Other topical anti-acne drugs on the face 
2 weeks 
Soaps containing antimicrobials on the face 
2 weeks 
Anti-inflammatory agents and corticosteroids on 
the face 
4 weeks 
Retinoids, including retinol on the face  
4 weeks 
Facial procedures, including chemical peel, 
microdermabrasion, light (PDT, LED) and laser 
therapy, and acne surgery 
4 weeks 
 
If the subject requires topical treatment for acne on areas other than the face, the investigator 
may prescribe a product that does not contain adapalene, clindamycin phosphate, or BPO. Any 
such medications must be noted in source documents and the eCRF. 
In addition, there is a mandatory washout period and restriction on use during the study for the 
following systemic drugs: 
Corticosteroids (including intramuscular injections; 
inhaled corticosteroids are allowed) 
4 weeks 
Antibiotics 
4 weeks 
Other systemic acne treatments 
4 weeks 
Systemic retinoids 
6 months 
 
Subjects using concomitant therapies during the course of the study that could interfere with the 
interpretation of the study results (including, but not limited to, those listed above) should not be 
withdrawn, but the use of the concomitant product should be discontinued. With the exception of 
the study drug and the products/treatments listed above, no other topical and/or physical 
treatment for acne will be permitted. 


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Information on concomitant medications or therapies will be recorded in the Prior and 
Concomitant Medication or Therapy source document and eCRF. Any therapy used by the 
subject will be considered concomitant therapy (e.g., facial procedures, surgical procedures, 
investigations, and operations), and any medication, both over-the-counter (OTC) or 
prescription, used by the subject will be considered concomitant medication  (eg, aspirin, 
Tylenol, birth control pills, vitamins). Every attempt should be made to keep concomitant 
medication / therapy dosing constant during the study. Any change to concomitant medication / 
therapy should be noted on the Concomitant Therapy or Medication source document and eCRF. 
All cleansers, moisturizers, sunscreens and other topical products used on the treatment area that 
are not medicated will be captured on the Prior and Concomitant Therapy source document and 
eCRF. Subjects must use investigator-approved, non-medicated cleansers, moisturizers, and 
sunscreens. 
Subjects should avoid excessive ultraviolet (UV) exposure by such activities as sun bathing or 
tanning booths. Use of sunscreens with at least SPF 15 and protective clothing during the day 
(eg, a hat) are recommended when exposure cannot be avoided.  
9.5 
Treatment Compliance 
Each subject will be instructed on the importance of returning his or her study drug at each 
applicable study visit. If a subject does not return his or her study drug at a particular study visit, 
he or she will be instructed to return it as soon as possible. The subjects will bring the pump(s) 
dispensed at each specified study visit to the next subsequent study visit. Each pump will be 
weighed on a calibrated scale (with the cap on, and to the nearest tenth of a gram) by a study 
coordinator or designee prior to dispensing and after collecting. The subject will also be asked to 
complete a diary calendar and will be questioned regarding study drug use since the previous 
visit in order to judge the subject’s compliance with applying the study drug. A subject who 
deviates meaningfully from the prescribed application amount will be counseled. Any missed 
applications of study drug will be noted by the subject on the diary, which will be collected and 
placed in the appropriate source document. Missed applications will be documented in the eCRF.  
9.6 
Protocol Deviations and Violations 
The investigators must read the protocol thoroughly and must follow the instructions exactly. 
A deviation from the protocol is an unintended and/or unanticipated departure from the 
procedures and/or processes approved by the Sponsor and the Institutional Review Board 
(IRB)/Independent Ethics Committee (IEC) and agreed to by the investigator. Deviations usually 
have an impact on individual subjects or a small group of subjects and do not involve 
inclusion/exclusion or primary endpoint criteria. 
A protocol violation occurs when there is non-adherence to the protocol that results in a 
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critical protocol requirements (eg, inclusion/exclusion criteria) and the subject was enrolled 
without prior Sponsor approval, or when there is non-adherence to FDA regulations and/or ICH 
GCP guidelines. 
The investigator or designee must document and explain in the subject’s source documentation 
any deviation from the approved protocol. The investigator may implement a deviation or 
protocol change to eliminate an immediate hazard to a study subject without prior IRB/IEC 
approval. As soon as possible after such an occurrence, the implemented deviation or change, the 
reasons for it, and any proposed protocol amendment(s) to prevent future occurrences, should be 
submitted to the IRB/IEC for review and approval, to the Sponsor for agreement, and to the 
regulatory authorities, if required. 
10 Study Drug Materials and Management 
The study drug will be dispensed by an appropriately qualified member of the study staff 
assigned by the investigator to this task. 
10.1 
IDP-126 Gel, IDP-126 Component A, B and C Gel, and IDP-126 Vehicle Gel 
The chemical names, chemical classes, and therapeutic classes of the active ingredients in 
IDP-126 Gel, IDP-126 Component A Gel, IDP-126 Component B Gel and IDP-126 Component 
C Gel are listed in Table 2. Information regarding the study drugs is presented in Table 3.  
Table 2. 
Drug Substances Identification 
Established Name 
Clindamycin Phosphate 
Chemical Name 
Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-
pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galactooctopyranoside 
2-(dihydrogen phosphate). 
Chemical Class 
Lincosamide antibiotic 
Therapeutic Class 
Anti-acne 
 
Established Name 
Benzoyl Peroxide 
Chemical Name 
Peroxide, Dibenzoyl 
Chemical Class 
Peroxide  
Therapeutic Class 
Anti-acne 
 
Established Name 
Adapalene 
Chemical Name 
(6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid) 
Chemical Class 
Synthetic retinoid 
Therapeutic Class 
Anti-acne 
 
 


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Table 3. Study Drug Identification  
 
Investigational Products 
Vehicle 
IDP-126  
Gel 
IDP-126  
Component A 
Gel 
IDP-126  
Component B 
Gel 
IDP-126  
Component C 
Gel 
IDP-126  
Vehicle Gel 
Name of 
Active 
Ingredient 
Clindamycin 
phosphate, BPO, 
and adapalene, 
USP 
BPO, 
USP/adapalene, 
USP 
Clindamycin 
phosphate/ 
BPO, USP 
Clindamycin 
phosphate/ 
adapalene, USP 
None 
Drug Name / 
Formulation/ 
Concentration 
Clindamycin 
phosphate 
1.2%/BPO 3.1%/ 
adapalene 
0.15%,  Gel 
BPO 
3.1%/Adapalene 
0.15%, Gel 
Clindamycin 
phosphate 1.2%/ 
BPO 3.1%, Gel 
Clindamycin 
phosphate 1.2%/ 
adapalene 0.15%, 
Gel 
IDP-126 Vehicle 
Gel 
Manufacturer 
 
Valeant Pharmaceuticals International, Inc. 
2150 St. Elzear Blvd West, Laval (Quebec), Canada H7L 4A8 
Packaging 
50 g White Pump 
Storage 
Requirements 
Store at 2-8 °C (36-46 °F) prior to dispensing. Once dispensed, the product should be stored at room 
temperature up to 25°C (77°F) and assigned a 5-week use-by date. Do not freeze. 
Appearance 
Opaque white to off-white gel 
Dosing 
Schedule 
Once daily × 12 weeks 
Route of 
Administration 
Topical Application 
 
10.1.1 Packaging and Labeling 
IDP-126 Gel, IDP-126 Component A Gel, IDP-126 Component B Gel, IDP-126 Component C 
Gel and IDP-126 Vehicle Gel will be supplied in subject kits. Instructions will be provided to the 
designated study drug technician at each study center. When a subject is randomized into the 
study, the IWRS-specified kit number will be assigned to be used for that randomized subject. 
Each subject kit will contain one pump, containing 50 g of study material. One pump will be 
dispensed to the subject at each dispensing visit: Baseline, Week 4, and Week 8. Each pump will 
be weighed on a calibrated scale, prior to dispensing (with the cap on, and to the nearest tenth of 
a gram). After weighing the pump and prior to first use of the study drug pump, the pump will 
need to be actuated approximately 10 times until the gel begins to dispense.  The pump is 
actuated by depressing the pump head using one or two fingers. This is to remove the air from 
the pump prior to product dispensing and is known as “priming the pump”. Priming the pump 
must occur at each dispensing visit (or if/when a replacement pump is issued).  
The subject will bring the pump to the next study visit (Week 2), where it will be collected and 
weighed (with the cap on, and to the nearest tenth of a gram) – a new pump will not be dispensed 
at this visit, and the original pump will be returned to the subject. The subject will then bring the 
same pump to the subsequent study visit (Week 4), where it will be collected and weighed (with 
the cap on) to the nearest 0.1 gram; one new pump will be dispensed again by the IWRS at Week 
4, weighed (with the cap on) to the nearest 0.1 gram and provided to the subject. The same will 


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occur at the Week 8 visit. If the subject loses a pump (lost or damaged pump), another kit will be 
dispensed via IWRS. All used and unused study drug pumps will be collected and weighed at the 
final study visit (Week 12). All dispensing and collecting of study drug pumps will be 
documented on the study drug accountability log.  
Each subject kit (and pump) label will have a double panel. Labels will contain, at a minimum, 
the following information: 
• Protocol Number 
• Kit Number 
• Contents 
• Space for entry of the subject initials and subject number 
• Space for entry of date dispensed 
• The sponsor name, Dow Pharmaceutical Sciences, a division of Valeant 
Pharmaceuticals NA, LLC 
• The quantity of product (50 g) 
• A statement reading, “For external use only; avoid contact with eyes and lips” 
• A statement reading,   “Store at 2-8 °C (36-46 °F) prior to dispensing. Once 
dispensed, the product should be stored at room temperature up to 25°C (77°F) and 
assigned a 5-week use by date. Do not freeze.” 
• A statement reading, “Caution: New Drug Limited by Federal Law to Investigational 
Use” 
10.1.2 Storage, Handling, and Disposal of Study Drug 
At the investigational center, the study drug should be stored at 2°C to 8°C (36°F to 46°F), and 
should not be frozen. Once opened and dispensed to the subject, the study drug should be stored 
at room temperature up to 25°C (77°F). All empty, partially used and unused study drug will be 
returned to the Sponsor or designee upon study completion of the study for documented disposal. 
10.1.3 Administration 
The study drug will be applied topically to the face once daily at home in the evening, at least 30 
minutes before bedtime, for a period of 12 weeks, with the exception of study visit days 
(Baseline, Week 2, 4, and 8) where study drug will be applied by the subject after the study visit 
is completed at the investigational center. The study drug will be applied as a thin coating that is 
gently rubbed into the skin. Study drug use will be limited to the face. 
The investigator and/or trained study center staff member will instruct the subject on the proper 
study drug application procedure during the Baseline visit (see Appendix 17.1). All subjects will 
be instructed to apply the study drug at approximately the same time every day for 12 weeks, 
after cleansing with an investigator-approved cleanser. On study visit days (Baseline, Weeks 2, 


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4, and 8) subjects should be instructed to wait until the end of their study visit to apply study 
medication at the investigational site (note, this will affect evening application times on study 
visit days, which is acceptable. Subjects should not apply another dose of study drug in the 
evening on the study visit days). No time interval between dosing and meals or any other activity 
is specified. Study center personnel oversight of a subject’s on-site application of study drug is 
required at Baseline, Week 4 and Week 8, to ensure training/reinforcement of proper application 
technique.  
During daily application, subjects will be instructed to gently wash their faces with an 
investigator-approved, non-medicated cleanser and warm (not hot) water. After washing, the 
subjects will be asked to thoroughly rinse and gently pat their faces dry. The subjects should use 
the pump to dispense one pea size amount of the study drug onto the fingertip.  The study drug 
gel should be dotted onto 6 areas of the face: the chin, left cheek, right cheek, nose, left forehead, 
and right forehead. After distributing the gel in this manner, the subject should gently rub the gel 
into the skin. This amount of drug should be sufficient to cover the entire face excluding the 
mouth, eyes, inside the nose, and lips. It is important for the subject to treat their entire face 
(excluding the mouth, eyes and lips) and they should be instructed NOT to treat only specific 
lesions. The subjects should gently smooth the study drug over the face evenly. The study drug 
should become invisible almost immediately following application with gentle rubbing. If this 
does not happen, the investigator should instruct the subject on the use of a smaller dosage. The 
subject should wash his/her hands after applying the study drug to the face. Subjects should also 
be instructed to place the cap back onto the pump after every use. 
At each study visit, study staff will review the subject instructions for application of study drug 
to ensure proper use and compliance with application. The subjects will be instructed to continue 
using the same investigator-approved, non-medicated facial cleanser, moisturizer, and sunscreen, 
and not to change products during the study. At each visit, subjects are to be asked if they have 
changed their cleansing routine. Facial makeup may be applied according to the subject’s normal 
daily routine; however, subjects should be instructed not to wear makeup during study visits as it 
may interfere with the evaluator’s assessments. Subjects must also agree to use non-
comedogenic makeup during the study if they use makeup. No other products should be used on 
the face. Subjects should be instructed to minimize sun exposure and to use investigator-
approved, non-medicated sunscreens of at least SPF 15 and to wear protective clothing during 
the day (eg, a hat) if exposure cannot be avoided.  
Subjects should be instructed to store the study drug at room temperature. If a subject loses or 
misplaces the pump cap at any point during the study, the subject should contact the study center 
to return the exposed pump and receive a replacement pump.  
10.2 
Study Drug Accountability 
Upon receipt of the study drug, the investigator is responsible for ensuring that the designated 
study center staff member will conduct a complete inventory of the study drugs and assume 


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responsibility for their appropriate storage and dispensing. In accordance with federal 
regulations, the investigators must agree to keep all study drugs in a secure location with 
restricted access. The investigator will keep a record of the inventory, dispensing, and collecting 
of all study drugs. This record will be made available to the Sponsor’s monitor for the purpose of 
accounting for all study drugs. Any significant discrepancy and/or deficiency must be recorded 
with an explanation. 
All supplies sent to the investigators will be accounted for and, in no case, used in any 
unauthorized situation. Pumps will be weighed on a calibrated scale (with the cap on, and to the 
nearest tenth of a gram) before dispensing to and upon return by the subjects, and weights will be 
recorded on the pharmacy log and appropriate eCRF. All used and unused supplies will be 
returned to Sponsor/designee for destruction at the conclusion of the study. If a subject 
loses/misplaces a cap, the pump should still be weighed using a cap from another pump/kit.  
11 Study Procedures and Evaluations 
All subject information and data obtained during the study visits will be recorded in the source 
documents, applicable study logs, and eCRFs. 
Evaluators must have appropriate, documented experience and training, or obtain approval from 
the Sponsor based on experience (or through additional training organized by the Sponsor). 
At each study visit, every attempt should be made to ensure that the same investigator/evaluator 
assesses the same subject.  
11.1 
Schedule of Evaluations and Procedures 
11.1.1 Visit 1: Screening Visit (Day −35 to Day 0) 
The following procedures will be conducted at this visit: 
1. Obtain written informed consent prior to performing any study procedures. Subjects less 
than the age of consent must sign an assent form, and the parent or legal guardian must 
sign the informed consent form. 
2. Assign the subject a 6-digit subject number by accessing IWRS. The number will consist 
of the 3-digit study center number (pre-assigned to your study center) and the 3-digit 
sequential order screening number assigned by the IWRS (eg, 101001, 101002; in this 
example study center number is 101). 
3. Record the subject’s demographic information. 
4. Record the subject’s medical history. 
5. Record all previous medications (including acne medications) used for the past 4 weeks 
(past 6 months for systemic retinoids). Record any therapies that will be used 
concomitantly during the study.  


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6. Perform an abbreviated physical examination, including height and weight, and measure 
vital signs (blood pressure, heart rate, respiration rate, and oral temperature). Note: height 
will only be measured at Screening, and not at subsequent study visits. 
7. Assess the subject using the EGSS, followed by inflammatory and non-inflammatory 
lesion counting to determine eligibility.  
8. Perform a urine pregnancy test for all females who are premenses and FOCBP. The urine 
pregnancy tests will be supplied by the CRO/designee.  
9. Verify that the subject meets the applicable inclusion/exclusion criteria as outlined in 
Sections 8.1 and 8.2.  
10. Discuss allowed cleansers, moisturizers, and sunscreens, and record any cleanser, 
moisturizer, and sunscreen use (Appendix 17.2). 
11. If subject wears makeup, remind the subject not to wear makeup during any future visits. 
12. If the subject requires a washout, schedule the Baseline visit to occur after the washout is 
complete. If no washout is required, the Screening and Baseline visits may occur on the 
same day.  
13. Schedule the subject to return for the Baseline/Day 0 visit. If the subject requires a 
washout, schedule the Baseline/Day 0 visit to occur after the washout is complete. 
NOTE: At the Baseline and Week 12 visits, serum pregnancy testing is mandatory for all pre-
menses females and FOCBP. A urine pregnancy test must be completed at all scheduled study 
visits. The decision may be made by the investigator to do additional pregnancy tests during the 
course of the study. 
11.1.2 Visit 2: Baseline Visit (Day 0)  
If a washout is not needed, this visit may occur on the same day as the Screening Visit (Visit 1). 
If a washout is needed, Visit 2 (Baseline) must occur after the appropriate washout period based 
on the criteria provided in Section 8.2.  
The following procedures will be conducted at this visit: 
1. The baseline Acne-QoL questionnaire will be completed by the subject and collected 
prior to conducting any other study-related procedures.  
2. Verify that the subject continues to meet the applicable inclusion/exclusion criteria as 
outlined in Sections 8.1 and 8.2. 
3. Record any changes in medical history since screening. 
4. Record changes in any concomitant medications or therapies since the previous visit 
under Prior and Concomitant Medications or Therapies. Check for prior and concomitant 
medications / therapies as per Section 9.4. 
5. Perform a urine pregnancy test for all females who are premenses and FOCBP. The urine 
pregnancy tests will be supplied by the CRO/designee. 


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6. Perform an abbreviated physical examination, including measurements of weight and 
vital signs (blood pressure, heart rate, respiration rate, and oral temperature). Any 
abnormal physical examination findings will be recorded. 
7. The evaluator will perform the Baseline efficacy evaluations including an assessment 
based on the EGSS, and counts of inflammatory and non-inflammatory lesions. The 
EGSS is performed prior to the lesion counting. Every effort should be made for the same 
qualified, validated evaluator to perform the efficacy evaluations at all visits from 
Baseline to Week 12 for the same subject.  
8. The evaluator will perform the Cutaneous Safety and Tolerability Evaluations. 
9. Collect blood samples for routine laboratory analysis (CBC/Diff, serum chemistry, and 
serum pregnancy for pre-menses females and FOCBP). 
10. Select Sites Only – Obtain representative photographs of the face. 
11. Assign the subject the appropriate kit number(s) (this number will be generated from the 
IWRS).  
12. The study coordinator or designee will weigh a pump from the assigned kit and dispense 
it to the subject. The pump will be weighed (with the cap on) using a calibrated scale. 
Record the weight of the pump to the nearest 0.1 g. A study diary calendar will also be 
dispensed and the subject will be instructed to bring it to all subsequent visits. 
13. The study coordinator or designee will instruct the subject on the proper application 
procedure for the study drug per Section 10.1.3, and will provide written subject use 
instructions to the subject (Appendix 17.1). For the first application, the subject will 
apply the study drug at the study center under the direction of the study coordinator or 
designee. The study drug should be applied after all clinical assessments. The study 
coordinator or designee will instruct the subjects to apply the study drug once daily at 
home at the same time of day, and will instruct the subject to use an investigator-
approved, non-medicated sunscreen of at least SPF 15, and to wear protective clothing 
during the day (eg, a hat) if exposure cannot be avoided.  
14. Record any AEs or changes in AEs since the screening visit and/or reported 
spontaneously by the subject. 
15. Schedule the next study visit at Week 2 (Day 14 ± 3 days). Remind the subject not to 
apply study drug on day of next study visit. 
NOTE: At the Baseline and Week 12 visits, serum pregnancy testing is mandatory for 
all pre-menses females and females of childbearing potential.  
11.1.3 Visit 3: Week 2 (Day 14 ± 3 Days) Visit 
The following procedures will be conducted at this visit (if a subject terminates early, all final 
visit [Week 12/Final Visit] procedures must be performed): 
1. The evaluator will perform the efficacy evaluations including the EGSS, inflammatory 
and non-inflammatory lesion counts. The EGSS is performed prior to the lesion counting. 
Every effort should be made for the same qualified and validated evaluator to perform the 
efficacy evaluations at all visits from Baseline to Week 12 for the same subject.  


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2. The evaluator will perform the Cutaneous Safety and Tolerability Evaluations. 
3. Record changes in any concomitant medications / therapies since the previous visit under 
Prior and Concomitant Medications or Therapies. Check for prior and concomitant 
medications / therapies as per Section 9.4. 
4. Record any new AEs reported spontaneously by the subject or changes in any ongoing 
AEs. 
5. Perform a urine pregnancy test for all females who are premenses and FOCBP. The urine 
pregnancy tests will be supplied by the CRO/designee. 
6. The study coordinator or designee will retrieve and weigh the used study drug pump. 
Record the weight of the pump (with the cap on) to the nearest 0.1 g. Note: a new pump 
will NOT be dispensed at this visit. The original pump will be re-dispensed back to the 
subject. 
7. The study diary calendar will be collected and reviewed for compliance. Any missed 
doses or deviations should be reported. A new study diary calendar will be dispensed. 
8. The study coordinator or designee will remind the subject of the proper technique for 
application of study drug (Section 10.1.3). At this visit, the subject will apply the study 
drug at the study center under the direction of the study coordinator or designee to 
confirm proper technique. Any necessary retraining can be completed. The study drug 
should be applied after all clinical assessments. The study coordinator or designee will 
remind the subjects to apply the study drug once daily at home in the evening up to the 
evening prior to the Week 12 visit (study drug will not be applied in the evening after this 
study visit). 
9. The study coordinator will instruct the subject to use a Sponsor/investigator-approved, 
non-medicated sunscreen of at least SPF 15, and to wear protective clothing during the 
day (eg, a hat) if exposure cannot be avoided. 
10. Schedule the next study visit at Week 4 (Day 28 ± 3 days). Remind the subject to not 
apply study drug on day of next study visit, prior to the clinic visit. 
11.1.4 Visit 4: Week 4 (Day 28 ± 3 Days) Visit 
The following procedures will be conducted at this visit (if a subject terminates early, all final 
visit [Week 12/Final Visit] procedures must be performed): 
1. The evaluator will perform the efficacy evaluations including the EGSS, inflammatory 
and non-inflammatory lesion counts. The EGSS is performed prior to the lesion counting. 
Every effort should be made for the same qualified and validated evaluator to perform the 
efficacy evaluations at all visits from Baseline to Week 12 for the same subject.  
2. The Evaluator will perform the Cutaneous Safety and Tolerability Evaluations. 
3. Record changes in any concomitant medications / therapies since the previous visit under 
Prior and Concomitant Medications or Therapies. Check for prior and concomitant 
medications / therapies as per Section 9.4. 
4. Record any new AEs reported spontaneously by the subject or changes in any ongoing 
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5. Perform a urine pregnancy test for all females who are premenses and FOCBP. The urine 
pregnancy tests will be supplied by the CRO/designee. 
6. The study coordinator or designee will collect/retrieve and weigh the used study drug 
pump and dispense the subject another pump containing study drug from the same kit 
number (i.e., the number that was generated by the IWRS). The new pump will be 
weighed (with the cap on) using a calibrated scale. Record the weight of the pump to the 
nearest 0.1 g.  
7. The study diary calendar will be collected and reviewed for compliance. Any missed 
doses or deviations should be reported. A new study diary calendar will be dispensed. 
8. Select Sites Only – Obtain representative photographs of the face.  
9. The study coordinator or designee will remind the subject of the proper technique for 
application of the study drug (Section 10.1.3). At this visit, the subject will apply the 
study drug at the study center under the direction of the study coordinator or designee to 
confirm proper technique. Any necessary retraining can be completed. The study drug 
should be applied after all clinical assessments. The study coordinator or designee will 
remind the subjects to apply the study drug once daily at home in the evening up to 
evening prior to Week 12 visit (study drug will not be applied in the evening after this 
study visit). 
10. The study coordinator will instruct the subject to use a Sponsor/Investigator-approved, 
non-medicated sunscreen of at least SPF 15, and to wear protective clothing during the 
day (eg, a hat) if exposure cannot be avoided. 
11. Schedule the next study visit at Week 8 (Day 56 ± 3 days). Remind the subject to not 
apply study drug on day of next study visit, prior to the clinic visit. 
11.1.5 Visit 5: Week 8 (Day 56 ± 3 Days) Visit 
The following procedures will be conducted at this visit (if a subject terminates early, all final 
visit [Week 12/Final Visit] procedures must be performed): 
1. The evaluator will perform the efficacy evaluations including the EGSS, inflammatory 
and non-inflammatory lesion counts. The EGSS is performed prior to the lesion counting. 
Every effort should be made for the same qualified and validated evaluator to perform the 
efficacy evaluations at all visits from Baseline to Week 12 for the same subject.  
2. The Evaluator will perform the Cutaneous Safety and Tolerability Evaluations. 
3. Record changes in any concomitant medications / therapies since the previous visit under 
Prior and Concomitant Medications or Therapies. Check for prior and concomitant 
medications / therapies as per Section 9.4. 
4. Record any new AEs reported spontaneously by the subject or changes in any ongoing 
AEs. 
5. Perform a urine pregnancy test for all females who are premenses and FOCBP. The urine 
pregnancy tests will be supplied by the CRO/designee. 
6. The study coordinator or designee will collect/retrieve and weigh the used study drug 
pump and dispense the subject another pump containing study drug from the same kit 


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number (i.e., the number that was generated by the IWRS). The new pump will be 
weighed (with the cap on) using a calibrated scale. Record the weight of the pump to the 
nearest 0.1 g.  
7. The study diary calendar will be collected and reviewed for compliance. Any missed 
doses or deviations should be reported. A new study diary calendar will be dispensed. 
8. Select Sites Only – Obtain representative photographs of the face. 
9. The study coordinator or designee will remind the subject of the proper technique for 
application of the study drug (Section 10.1.3). At this visit, the subject will apply the 
study drug at the study center under the direction of the study coordinator or designee to 
confirm proper technique. Any necessary retraining can be completed. The study drug 
should be applied after all clinical assessments. The study coordinator or designee will 
remind the subjects to apply the study drug once daily at home in the evening up to 
evening prior to Week 12 study visit (study drug will not be applied in the evening after 
this study visit). 
10. The study coordinator will instruct the subject to use a Sponsor/Investigator approved, 
non-medicated sunscreen of at least SPF 15, and to wear protective clothing during the 
day (eg, a hat) if exposure cannot be avoided. 
11. Schedule the next study visit at Week 12 (Day 84 -3/+5 days). Remind the subject to not 
apply study drug on day of next study visit, prior to the clinic visit. 
11.1.6 Visit 6: Week 12 (Day 84 -3/+5 Days) Visit – End of Study Visit 
The following procedures will be conducted at this visit: 
1. The Acne-QoL questionnaire will be completed by the subject and collected prior to any 
other study related procedures. 
2. Perform an abbreviated physical examination, including measurements of weight and 
vital signs (blood pressure, heart rate, respiration rate, and oral temperature). Any 
abnormal physical examination findings will be recorded. 
3. The evaluator will perform the efficacy evaluations including the EGSS, inflammatory 
and non-inflammatory lesion counts. The EGSS is performed prior to the lesion counting. 
Every effort should be made for the same qualified and validated evaluator to perform the 
efficacy evaluations at all visits from Baseline to Week 12 for the same subject.  
4. The evaluator will perform the Cutaneous Safety and Tolerability Evaluations. 
5. Record changes in any concomitant medications / therapies since the previous visit under 
Prior and Concomitant Medications or Therapies. Check for prior and concomitant 
medications / therapies as per Section 9.4. 
6. Record any new AEs reported spontaneously by the subject or changes in any ongoing 
AEs. 
7. The study diary calendar will be collected and reviewed for compliance. Any missed 
doses or deviations should be reported. 


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8. The study coordinator or designee will retrieve all study drug (pump[s]) from the subject 
and weigh the pump(s) using a calibrated scale. The weight of the pump(s) (with the cap 
on) should be recorded to the nearest 0.1 g. 
9. Perform a urine pregnancy test for all females who are premenses and FOCBP. The urine 
pregnancy tests will be supplied by the CRO/designee. 
10. Collect blood samples for routine laboratory analysis (CBC/Diff, serum chemistry, and 
serum pregnancy for all pre-menses females and FOCBP).  
11. Select Sites Only – Obtain representative photographs of the face. 
12. Exit the subject from the study and complete the end of study eCRFs. 
11.2 
Evaluation of Efficacy 
The determination of efficacy will be based on evaluator-blinded assessments of the signs and 
symptoms of acne vulgaris. Evaluators must be a board-certified/board-eligible dermatologist or 
have appropriate documented experience and training, and be present for formal study training 
and validation at the Investigator Meeting (and/or Site Initiation Visit), or obtain a waiver from 
the Sponsor based on experience (or through additional training organized by the Sponsor).  
The EGSS assessments and lesion counts will be performed at each study visit. The EGSS 
assessments will be collected before the lesion counts. All subject assessments will be performed 
by a trained and validated evaluator. Every effort should be made to have the same evaluator 
assess the same subject at each visit. If this is not possible, the same evaluator should assess the 
subject at both the Baseline and Week 12 visits.  
11.2.1 Evaluator’s Global Severity Score 
The EGSS will be a static assessment that is independent of the baseline score. The investigator 
will make the assessment without referring to the baseline value. Every effort should be made for 
the same evaluator to perform each study assessment for the same study subject, for consistency 
in evaluations.  
Subjects are eligible if they have acne vulgaris with a global severity of 3 (moderate) or 
4 (severe) on the EGSS at the Baseline visit. The following scores will be used to describe the 
severity grade and subsequent score: 
Table 4. 
Evaluator’s Global Severity Score 
Score 
Grade 
Description 
0 
Clear 
Normal, clear skin with no evidence of acne vulgaris 
1 
Almost 
Clear 
Rare non-inflammatory lesions present, with rare noninflamed papules (papules must be 
resolving and may be hyperpigmented, though not pink-red) 
2 
Mild 
Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules 
only; no nodulocystic lesions) 
3 
Moderate 
Non-inflammatory lesions predominate, with multiple inflammatory lesions evident: several 
to many comedones and papules/pustules, and there may or may not be 1 nodulocystic lesion 
4 
Severe 
Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or 


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may not be up to 2 nodulocystic lesions 
 
11.2.2 Lesion Counts 
The facial area lesion counts will be taken from the subject’s face (including the nose). The 
lesion count groups will be inflammatory and non-inflammatory. Facial inflammatory lesions 
(pustules, papules, and nodules) will be counted as follows: pustules and papules will be counted 
and recorded together, not separately; nodular lesions will be counted and recorded separately. 
Non-inflammatory lesions (open and closed comedones) will be counted and recorded together. 
The lesion counts will be collected at each visit and/or upon discontinuation.  The following are 
definitions of each lesion type counted: 
Inflammatory lesions are defined as follows: 
 
Papule – a solid, elevated lesion less than 5 mm 
Pustule – an elevated lesion containing pus less than 5 mm 
Nodule – palpable subcutaneous lesion greater than 5 mm; has depth, not necessarily elevated 
 
Non-inflammatory lesions are defined as follows: 
 
Open comedones (blackhead) – plugged hair follicle with dilated/open orifice; black in color 
Closed comedones (whitehead) – plugged hair follicle: small opening at skin surface 
11.2.3 Other Assessments 
Photography 
At select study centers, photographs of the face will be taken at Baseline and at Weeks 4, 8, and 
12. Only subjects who provide written photographic consent for facial photographs will be 
included in photography. 
11.3 
Evaluation of Safety 
Safety assessments will be conducted at baseline and each subsequent study visit.  
11.3.1 Cutaneous Safety Evaluations 
Cutaneous safety will be evaluated through an assessment, conducted at the time of the study 
visit, of selected local signs (i.e., signs present at the study drug application site) that include the 
following: scaling, erythema, hypopigmentation, and hyperpigmentation. The evaluator will 
assess all cutaneous safety signs. 
Cutaneous safety signs that result in the subject’s requiring a concomitant therapy, interruption 
of treatment, or discontinuation from the study, will be reported as an AE.  
Scaling: 
0 – None  
No scaling  
1 – Mild  
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2 – Moderate Fine scale generalized to all areas of the face 
3 – Severe  
Scaling and peeling of skin over all areas of the face 
 
Erythema: 
0 – None  
No evidence of erythema present  
1 – Mild  
Slight pink coloration 
2 – Moderate Definite redness 
3 – Severe  
Marked erythema, bright red to dusky dark red in color 
Hypopigmentation: 
0 – None  
No evidence  
1 – Mild  
Slight, barely perceptible 
2 – Moderate Definite, evident 
3 – Severe  
Marked, prominent 
Hyperpigmentation: 
0 – None  
No evidence  
1 – Mild  
Slight, barely perceptible 
2 – Moderate Definite, evident 
3 – Severe  
Marked, prominent 
11.3.2 Tolerability Evaluations 
Tolerability will be evaluated through an assessment, at the time of the study visit, of selected 
local symptoms (i.e., symptoms present at the study drug application site) that include itching, 
burning, and stinging. The subject will self-assess all tolerability symptoms; the assessment will 
be based on an average over the period since the previous study visit. 
Tolerability symptoms that result in the subject’s requiring a concomitant therapy, interruption of 
treatment, or discontinuation from the study, will be reported as an AE. 
Itching: 
0 – None   
No itching  
1-   Mild   
Slight itching, not really bothersome  
 
2 – Moderate  Definite itching that is somewhat bothersome 
 
 
3 – Severe  
Intense itching that may interrupt daily activities and/or sleep  
 
Burning: 
0 – None   
No burning 
 
  
1 – Mild  
Slight burning sensation; not really bothersome  
 
2 – Moderate  Definite warm, burning sensation that is somewhat bothersome 
3 – Severe  
Hot burning sensation that causes definite discomfort and may   
 
 
 
 
 
 
 
 
interrupt daily activities and/or sleep  
 
 
Stinging: 
0 – None  
No stinging 
 
  
1 – Mild   
Slight stinging sensation, not really bothersome   
 
2 – Moderate  Definite stinging sensation that is somewhat bothersome 
 


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3 – Severe  
Stinging sensation that causes definite discomfort and may interrupt daily 
activities and/or sleep 
11.3.3 Medical History and Abbreviated Physical Examination 
A medical history will be taken at Screening, and confirmed and revised if needed, at Baseline. 
Medical histories having resolved 2 or more years before Baseline need not be collected unless 
considered relevant by the investigator. 
An abbreviated physical examination including measurements of weight and vital signs (blood 
pressure, heart rate, respiration rate, and oral temperature) will be performed at Screening, 
Baseline and Week 12 (end of treatment/study); height will also be measured, but only at the 
Screening visit. Any abnormal physical examination findings will be recorded. 
11.3.4 Laboratory Tests 
Clinical laboratory analyses (CBC/Diff and serum chemistry) will be conducted on blood 
samples collected from subjects at Baseline and Week 12. All results will be reported, including 
results that are abnormal. Clinically significant results, in the opinion of the investigator, should 
be reported as AEs. If an AE should require laboratory testing, the results of the test must be 
obtained by the study center and filed in the subject’s documentation.  
For pre-menses females and FOCBP, a serum pregnancy test will be conducted at Baseline and 
Week 12.  
11.3.5 Pregnancy Tests 
All females who are pre-menses and FOCBP will undergo serum pregnancy testing at the 
Baseline and Week 12 study visits, and urine pregnancy testing at Screening, prior to 
randomization at Baseline, and at Weeks 2, 4, 8 and 12. The urine pregnancy tests will be 
supplied by the CRO/designee. 
11.4 
Adverse Events 
11.4.1 Definition of Adverse Event 
An AE is any untoward medical occurrence in a patient or clinical investigation subject 
administered a medicinal product and which does not necessarily have a causal relationship with 
the study drug. AEs include any unfavorable and unintended illness, sign, symptom, clinically 
significant laboratory test abnormality, or disease temporally associated with the use of a 
medicinal product that has appeared or worsened during the course of the clinical trial, regardless 
of causal relationship to the study drug(s) under study. AEs include any illness, sign, symptom, 
or out-of-range and clinically significant laboratory finding that has appeared or worsened during 
the course of the clinical trial, regardless of causal relationship to the study. The collection of 
nonserious AEs and SAEs will begin following the subject's completion of the consent process to 
participate in the study. 


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11.4.2 Documenting Adverse Experiences 
It is the responsibility of the investigator to document all AEs that occur during the course of the 
study. The AEs should be documented as a single medical diagnosis. When this is not possible, 
the AE should be documented in terms of signs and/or symptoms observed by the investigator or 
reported by the subject at each study visit. Each AE which appears to be independent of any prior 
event will be reported separately. 
All AEs occurring after the subject signs the informed consent through the last study visit must 
be reported, regardless of whether or not the AEs are considered study drug-related. All AEs, 
whether in response to a query, observed by the study center personnel, or reported 
spontaneously by the subject, will be recorded. Any AEs deemed related to treatment reported or 
observed at the final study/treatment visit will be followed until stabilization or resolution (or up 
to 30 days after final study visit). 
At each visit during the study, the subject will be assessed for the occurrence of new and ongoing 
AEs. Cutaneous safety and tolerability signs and symptoms that result in the subject’s requiring a 
concomitant therapy, interruption of treatment, or discontinuation from the study will be reported 
as an AE. The following data will be collected on all AEs and recorded on the appropriate eCRF: 
• Event description (diagnosis preferred, if unknown, record the signs/symptoms) 
• Onset date and end date 
• Maximum intensity (severity) 
• Seriousness 
• Action taken regarding study drug 
• Corrective treatment, if given 
• Outcome 
In addition, the investigator’s assessment of causality will be recorded. 
Vital sign abnormalities are to be recorded as AEs only if they are clinically significant (for 
example: are symptomatic, requiring corrective treatment, leading to discontinuation or fulfilling 
a seriousness criterion). 
11.4.3 Serious Adverse Events 
All AEs will be assessed as either serious or nonserious. An SAE is defined as any untoward 
medical occurrence that, at any dose: 
• results in death. 
• is immediately life threatening, (the term “life threatening” in the definition of 
“serious” refers to an event in which the subject is at risk of death at the time of the 


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event; it does not refer to an event which hypothetically might have caused death if it 
were more severe). 
• requires in patient hospitalization or prolongation of existing hospitalization 
(hospitalization for elective surgery for a baseline condition is not considered an AE). 
• results in persistent or significant disability/incapacity (permanent or substantial 
disruption of a person’s ability to conduct normal life functions). 
• is a congenital anomaly/birth defect. 
• is a medically important event that may not be immediately life threatening or result 
in death or hospitalization, but may jeopardize the subject and may require medical or 
surgical intervention to prevent one of the above listed outcomes; examples of such 
events include, but are not limited to, allergic bronchospasm requiring intensive 
treatment in an emergency room or at home; blood dyscrasias or convulsions that do 
not result in inpatient hospitalization. 
Note: A spontaneous abortion will be considered an SAE and must be reported per Reporting of 
SAEs under Section 11.4.6. 
11.4.4 Assessment of Severity 
The severity assigned to an AE should be determined by the maximum severity of the AE. The 
categories described below should be used to estimate the severity of AEs: 
• Mild: Transient or mild discomfort; no limitation in activity; no medical 
intervention/therapy required. 
• Moderate: Mild to moderate limitation in activity; some assistance may be needed; no 
or minimal medical intervention/therapy required. 
• Severe: Marked limitation in activity; some assistance usually required; medical 
intervention/therapy required; hospitalization or prolongation of current 
hospitalization possible; may be incapacitating or life threatening. 
11.4.5 Assessment of Causality 
The investigator should assess the relationship of the AE, if any, to the study drug as either 
“Related” or “Not Related.” The following should be taken into account when assessing AE/SAE 
causality: 
• Related: There is at least a reasonable possibility that the AE/SAE is related to the 
study drug. Reasonable possibility means that there is evidence to suggest a causal 
relationship between the drug and the AE. 
• Not Related: There is little or no reasonable possibility that the AE/SAE is related to 
the study drug. This assessment implies that the AE/SAE has little or no temporal 


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relationship to the study drug and/or a more likely or certain alternative etiology 
exists.  
11.4.6 Reporting of Serious Adverse Events 
Adverse events classified as “serious” require expeditious handling and reporting to sponsor or 
designee within 24 hours of study center notification to comply with regulatory requirements. 
All SAEs, whether related or unrelated to study drug, must be immediately reported to the 
medical monitor and CRO contact within 24 hours of the investigator’s awareness of the event. 
All SAEs must be reported via confirmed facsimile or email transmission and must be submitted 
on a written SAE report form signed by the investigator within 24 hours of the investigator’s 
awareness of the event. 
The contact(s) for reporting an SAE are: 
 
 
 
Investigators should not wait to receive additional information to fully document the event 
before notifying medical monitor and Sponsor of an SAE. If only limited information is initially 
available, follow-up reports are required. Additional relevant information such as hospital 
records and autopsy reports should be provided to the Sponsor as soon as they are available. 
Should the investigator become aware of an SAE (regardless of its relationship to study drug) 
that occurs within 30 days after stopping the study drug, the SAE must be reported in accordance 
with procedures specified in this protocol. 
All deaths of subjects, regardless of cause, and which are known to the Investigator will be 
reported on the appropriate eCRF for up to 30 days after the administration of study drug, 
regardless of the Investigator's opinion regarding drug relationship. Documentation of the 
subject’s cause of death and a copy of the autopsy or hospital report will also be provided. The 
Medical Monitor and CRO contact must be notified within 24 hours of knowledge of the event 
by telephone (and/or facsimile/email) of all subject deaths. Written follow-up must be received 
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The investigator should take all appropriate measures to ensure the safety of the subjects, notably 
he/she should follow a subject with an SAE until the event has resolved or the condition has 
stabilized. This may imply that follow-up will continue after the subject has left the study, and 
that additional investigations may be requested by the Sponsor. When a SAE persists at the end 
of the study, the investigator will conduct follow-up contacts with the subject until the 
investigator/Sponsor agree the event is satisfactorily resolved and/or stabilized. If at any time 
after 30 days after administration of study drug, the investigator becomes aware of an SAE 
which he/she feels is related to study drug or procedure, this must also be reported immediately 
(within 24 hours of knowledge of occurrence) by telephone and confirmed facsimile 
transmission/email to the medical monitor and Sponsor and/or Sponsor designee. 
11.4.7 Expedited Serious Adverse Event Reports 
An AE, whether serious or nonserious, is designated unexpected (unlabeled) if it is not reported 
in the clinical safety section of the Investigator Brochure or if it is of greater frequency, 
specificity, or severity than what is reported in the clinical safety section of the Investigator 
Brochure. 
Expedited SAE reports are those that are both unexpected based on the reference document 
(Investigator Brochure) and are related (i.e., the relationship cannot be ruled out) to the study 
drug. These expedited reports are subject to reporting timelines of 7 and/or 15 calendar days to 
the regulatory reporting agency(ies). The Sponsor will notify regulatory authorities of these AEs 
and all participating study centers in writing for submission by the investigator to the IRB/IEC. 
This notification will be in the form of a safety update to the Investigator Brochure (i.e., a “15-
day letter”). 
Upon receiving such notices, the investigator must review and retain the notice with the 
Investigator Brochure and immediately submit a copy of this information to the responsible 
IRB/IEC according to local regulations. The investigator and IRB/IEC will determine if the 
informed consent requires revision. The investigator should also comply with the IRB/IEC 
procedures for reporting any other safety information. 
11.4.8 Pregnancy 
All pre-menses females and FOCBP must use an effective method of birth control during the 
course of the study, in a manner such that risk of contraceptive failure is minimized. Abstinence 
is allowed as a birth control method. 
Before enrolling a pre-menses female or FOCBP in this clinical study, the investigator must 
review the following information about study participation: 
• Informed consent requirements 
• Contraceptives in current use 


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Following review of this information and appropriate subject counseling, the investigator or 
designee and the subject must sign the informed consent/assent before study enrollment. 
During the study, all pre-menses females and FOCBP should be instructed to contact the 
investigator immediately if they suspect they might be pregnant (eg, missed or late menstrual 
period). 
If a subject or investigator suspects that the subject may be pregnant prior to study enrollment, 
the study drug must be withheld until the results of laboratory pregnancy testing are available. If 
pregnancy is confirmed, the subject must not receive study drug and must not be enrolled in the 
study. If pregnancy is suspected while the subject is receiving study drug, the study drug must 
immediately be withheld until the result of pregnancy testing is known. If pregnancy is 
confirmed, the study drug will be permanently discontinued and the subject will be followed 
until the pregnancy comes to term. A Pregnancy Report Form will be submitted to the sponsor, 
initially and at the end of the pregnancy, which includes the outcome of the pregnancy and any 
complications occurring during the pregnancy or the delivery. If any SAEs are associated with 
the pregnancy, including spontaneous abortion/miscarriage, an SAE form must be filled out in 
addition to the Pregnancy Report Form and submitted as per section 11.4.6.  
All confirmed pregnancies must be immediately reported to the medical monitor and CRO 
contact within 24 hours of the investigator’s awareness of the pregnancy. All confirmed 
pregnancies are to be reported on a pregnancy form using the same reporting procedure for an 
SAE under Section 11.4.6.  
12 Statistics 
All statistical processing will be performed using SAS® version 9.3 or later unless otherwise 
stated. Statistical significance will be based on 2-tailed tests of the null hypothesis resulting in 
p-values of 0.05 or less. 
A statistical analysis plan, describing all statistical analyses will be provided as a separate 
document. The SAP will be finalized prior to unblinding of the study treatments. 
All efficacy assessments will be conducted using both the intent-to-treat (ITT) (primary) and 
per-protocol (PP) (supportive) analysis sets. All safety assessments will be conducted using the 
safety analysis set. 
12.1 
Assessment of Efficacy 
Inflammatory lesions and non-inflammatory lesions will be recorded for each subject at Baseline 
and at Weeks 2, 4, 8, and 12. The absolute and percent change from baseline of inflammatory 
lesions and non-inflammatory lesions will be derived for each subject at Weeks 2, 4, 8, and 12. 


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The EGSS will be recorded for each subject throughout the study. Treatment success will be 
defined as at least a 2-grade improvement from Baseline in the EGSS assessment, and an EGSS 
equating to “clear” or “almost clear.” 
12.1.1 Primary Efficacy 
The co-primary efficacy endpoints are intended to compare the numerical superiority of once 
daily application of IDP-126 Gel with IDP-126 Vehicle Gel and each of the dual gel 
components. Specifically, the co-primary efficacy endpoints include: 
• Absolute change in inflammatory lesion count from baseline to Week 12, as 
summarized using descriptive and inferential statistics 
• Absolute change in non-inflammatory lesion count from baseline to Week 12, as 
summarized using descriptive and inferential statistics 
• Proportion of subjects who have a least a 2-grade reduction at Week 12 from baseline 
in the EGSS and are “clear” or “almost clear”, as summarized using descriptive and 
inferential statistics 
12.1.2 Secondary Efficacy 
The secondary efficacy endpoints are intended to compare the numerical superiority of once 
daily application of IDP-126 Gel with IDP-126 Vehicle Gel and each of the dual gel 
components. Specifically, the secondary efficacy endpoints include: 
• 
Absolute change in inflammatory and non-inflammatory lesion counts from baseline 
at Weeks 2, 4, and 8, as summarized using descriptive statistics 
• 
Proportion of subjects who achieve at least a 2-grade reduction from baseline and are 
“clear” or “almost clear” at Week 2, 4, and 8 in the EGSS, as summarized using 
descriptive statistics 
• 
Mean percent change in inflammatory and non-inflammatory lesion counts from 
baseline at Weeks 2, 4, 8, and 12, as summarized using descriptive statistics 
12.1.3 Test of Superiority for Lesion Count Variables Evaluator's Global Severity Score 
P-values for selected variables will be presented to assist the reviewer in evaluating the outcome 
of the study. Failure to achieve a statistically significant result at an alpha level of 0.05 does not 
imply a failed study.  
The absolute change in mean inflammatory and non-inflammatory lesion counts from Baseline to 
Week 12 will be analyzed with an analysis of covariance (ANCOVA) with factors of treatment 
group and analysis center and a covariate of their respective baseline lesion count. Additionally, 
4 pairwise tests will be conducted comparing the IDP-126 Gel to IDP-126 Vehicle Gel and IDP-
126 Gel to each of the component gels (A, B, and C). 
A skewness test, based on the methods presented by Zar (1984) will be applied to the residuals 
resulting from an ANCOVA. A 2-sided p-value for the skewness test significant at 0.01 will 


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imply the use of the nonparametric method. If a parametric analysis is indicated, the results of 
the parametric analysis will be considered the primary analysis. Should a nonparametric analysis 
be indicated, the absolute of percent changes in inflammatory and non-inflammatory lesions will 
be rank transformed prior to submitting them to the ANCOVA. Results of the rank transformed 
analyses then will be considered the primary analysis; however, results of the nonrank 
transformed analyses will also be presented. 
The percent of subjects with treatment success, defined as at least a 2-grade improvement from 
Baseline in the EGSS and an EGSS equating to “clear” or “almost clear” will be analyzed with a 
logistic regression test with factors of treatment group and analysis center and a covariate of 
baseline severity at Week12. Four pairwise tests will be conducted comparing the IDP-126 Gel 
to IDP-126 Vehicle Gel and IDP-126 Gel to each of the component gels (A, B, and C).  
12.1.4 Statistical Hypothesis Testing and Control of Multiplicity 
Not Applicable. 
12.1.5 Descriptive Statistics 
Descriptive statistics will be presented for the following parameters by treatment group for both 
the ITT and PP analysis sets: 
• Frequency and percent distributions of the EGSS at Baseline and Weeks 2, 4, 8, and 
12. 
• Frequency and percent distributions of the dichotomized EGSS at Baseline and 
Weeks 2, 4, 8, and 12. 
• Descriptive statistics including mean, median, standard deviation, minimum, and 
maximum will be used to summarize inflammatory and non-inflammatory lesion 
counts at Baseline and Weeks 2, 4, 8, and 12.  
• Descriptive statistics including mean, median, standard deviation, minimum, and 
maximum will be used to summarize the absolute and percent change in 
inflammatory and non-inflammatory lesion counts at Weeks 2, 4, 8, and 12. 
12.1.6 Missing Efficacy Data Imputations 
Lesion Count Variable Missing Data Imputation 
Missing 12-week data will be estimated by multiple imputation and subsequently analyzed. 
Missing lesion count data will be derived for the analysis using the method of Markov Chain 
Monte Carlo (MCMC) multiple imputation. The pattern of missing observations in each 
treatment group will not influence the missing value estimation in the other because the 
imputation is being conducted independently for each treatment group. 
Multiple imputation and subsequent analysis will involve 4 distinct phases with these principal 
tasks: 
 


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1. Calculate the number of missing values to be estimated by MCMC (nmiss) for 12-week 
value. 
2. Create a data set of subjects, one for each treatment group, with observed values and 
those needing estimation by MCMC.  The missing lesion count values in each data set 
will be filled in using the MCMC method ‘5 x nmiss’ times to generate ‘5 x nmiss’ data 
sets.  The resulting data sets for each treatment arm will be combined into one complete 
data set for each imputation. 
Syntax: 
proc mi data=datain out=dataout seed=&seed. nimpute=5xnmiss <options>; 
where trtpn=(1, 2, 3, 4, 5); 
mcmc chain=multiple; 
var baseline week2 week4 week8 week12; 
run; 
3. For each complete data set, the absolute change in lesion counts for baseline minus the 
12-week value will be computed. Each complete data set will be analyzed as specified for 
the particular analysis. 
4. The results from these analyses will be combined into a single inference using SAS 
PROC MIANALYZE. 
A total of 410 random seeds will be needed to impute inflammatory lesion counts and non-
inflammatory lesion counts for the five treatment groups. Those 410 random seeds have been 
pre-specified by using a random number generator: 
• 
Inflammatory Lesion Counts; IDP-126 Gel: Seed= 1754456209 
• 
Inflammatory Lesion Counts; IDP-126 Component A Gel: Seed= 122264983 
• 
Inflammatory Lesion Counts; IDP-126 Component B Gel: Seed= 976959487 
• 
Inflammatory Lesion Counts; IDP-126 Component C Gel: Seed= 703462539 
• 
Inflammatory Lesion Counts; IDP-126 Vehicle Gel: Seed= 2119568680 
• 
Non-Inflammatory Lesion Counts; IDP-126 Gel: Seed= 2077006677 
• 
Non-Inflammatory Lesion Counts; IDP-126 Component A Gel: Seed= 1107085314 
• 
Non-Inflammatory Lesion Counts; IDP-126 Component B Gel: Seed= 1481157948 
• 
Non-Inflammatory Lesion Counts; IDP-126 Component C Gel: Seed= 804168452 
• 
Non-Inflammatory Lesion Counts; IDP-126 Vehicle Gel: Seed= 970145727 
 
EGSS Missing Data Imputation 
A similar procedure will be used for the analyses based on proportion of EGSS successes 
wherein the ANCOVA analysis is replaced with a logistic regression analysis.  Specifically, 
missing 12 week EGSS values from which the dichotomized EGSS is derived will be estimated 


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by (MCMC). The pattern of missing observations in each treatment group will not  influence the 
missing value estimation in the other because the imputation is being conducted independently 
for each treatment group. 
The missing 12 week EGSS values will be derived for the analysis using the method of Markov 
Chain Monte Carlo (MCMC) multiple imputation. Multiple imputation and subsequent analysis 
will involve 4 principal tasks: 
1. Calculate the number of missing values to be estimated by MCMC (nmiss) for 12-week 
value. 
2. Create a data set, one for each treatment group, of subjects with observed values and 
those needing estimation by MCMC.  The missing EGSS values in each data set will be 
filled in using the MCMC method ‘5 x nmiss’ times to generate ‘5 x nmiss’ data sets. The 
resulting data sets for each treatment arm will be combined into one complete data set by 
imputation. 
Syntax: 
proc mi data=datain out=dataout seed=&seed. nimpute=5xnmiss <options>; 
  where trtpn=(1, 2, 3, 4, 5); 
  mcmc chain=multiple; 
  var baseline week2 week4 week8 week12; 
run; 
3. For each complete data set, the dichotomous success rate (clear or almost clear with a 2-
point change from baseline) will be computed. The 12-week estimated global values will 
be rounded to the nearest integer value prior to evaluating the success rate. Each 
complete data set will be analyzed with a logistic regression with factors of treatment 
group and analysis center. 
4. The results from these analyses will be combined into a single inference using SAS 
PROC MIANALYZE. 
A total of 5 random seeds will be needed to impute EGSS for the five treatment groups. Those 5 
random seeds have been pre-specified by using a random number generator: 
• 
EGSS; IDP-126 Gel: Seed= 1648890376 
• 
EGSS; IDP-126 Component A Gel: Seed= 643914697 
• 
EGSS; IDP-126 Component B Gel: Seed= 221882819 
• 
EGSS; IDP-126 Component C Gel: Seed= 862442634 
• 
EGSS; IDP-126 Vehicle Gel: Seed= 1951544161 
Missing 12 week data will be estimated by MCMC multiple imputation conducted independently 
for each treatment group. The details of this method as well as other methods will be specified in 
the statistical analysis plan which will be finalized prior to data base lock. 


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12.2 
Assessment of Safety 
Safety will be evaluated by tabulations of AEs, and Cutaneous Safety and Tolerability 
Evaluations. Cutaneous Safety Evaluation scores (erythema, scaling, hypo/hyper-pigmentation) 
and Tolerability (itching, burning, and stinging) will be presented with descriptive statistics at 
Baseline and at Weeks 2, 4, 8, and 12 for each treatment group. In addition, the percent of 
subjects who experience a cutaneous reaction graded at a level of 3 at any point in the study 
following the first application of study drug will be tabulated. Frequencies and percentages for 
each outcome category will be included in these statistics. Mean values will be presented 
graphically by week and treatment group. 
12.2.1 Adverse Events 
All AEs occurring during the study will be recorded and classified on the basis of Medical 
Dictionary for Regulatory Activities terminology. Descriptions of AEs will include the date of 
onset, the date the AE ended, the severity of the AE, the relationship to study drug, the action 
taken regarding study drug usage, the action taken to treat the AE, and the outcome.  
Treatment-emergent adverse events (TEAEs) are those events with an onset on or after the date 
of the first study drug application. All reported TEAEs will be summarized by the number of 
subjects reporting TEAEs, system organ class, preferred term, severity, seriousness, and 
relationship to study drug. 
Adverse events will be summarized by treatment group and severity. Each subject will be 
counted only once within a system organ class or a preferred term by using the AEs with the 
highest severity within each category. 
Adverse events will be summarized by treatment group and relationship to study drug. Each 
subject will be counted only once within a system organ class or a preferred term by using the 
AEs with the greatest relationship within each category. 
All information pertaining to AEs noted during the study will be listed by subject, detailing the 
verbatim term given by the investigator, preferred term, system organ class, start date, stop date, 
severity, action taken, and drug relatedness. The AE onset will also be shown relative (in number 
of days) to the day of initial dose of the randomized study drug. 
Serious adverse events will be tabulated by subject within treatment groups. 
In addition, a list of subjects who discontinued from the study and a list of subjects who 
experienced SAEs will also be provided. 
12.2.2 Safety Laboratory Tests 
Changes from baseline in safety laboratory values will be summarized with descriptive statistics 
at all applicable study visits. Shift tables will be presented for changes in safety laboratory 
values. Normal ranges established by the central laboratory will be used to determine the shifts. 
A listing of all out-of-range laboratory test results at any assessment time point will also be 


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provided. Determination of clinical significance for all out-of-range laboratory values will be 
made by each investigator and included in the listing. In addition, a listing of all clinically 
significant laboratory test results will be provided. 
12.2.3 Vital Sign Measurements 
Changes from baseline in vital sign measurements will be summarized with descriptive statistics 
for each treatment group at all applicable study visits. 
12.2.4 Concomitant Medications 
All previous and concomitant medications will be classified based on terminology from the 
World Health Organization Drug Dictionary. Previous therapies and concomitant medications 
data will be presented in data listings. 
12.2.5 Subject Self-Assessments 
Subjects will be asked to complete the Acne-QoL questionnaire (Appendix 17.3). Descriptive 
statistics will be used to summarize the data reported from the questionnaire. No inferential 
statistical analyses will be conducted.  
12.3 
Subject Disposition 
A tabulation of subject disposition will be provided. The tabulation will include the numbers of 
subjects who enter the study, complete the study, and discontinue the study. The reasons for 
discontinuation will be included. 
12.4 
Demographics and Baseline Characteristics 
Subject demographic and baseline characteristics will be summarized by study drug group for 
the Safety, ITT and the PP analysis sets. For continuous variables (eg, age, lesion counts), 
comparisons among the 5 study drug groups will be conducted using a 2-way analysis of 
variance with factors of treatment and analysis center. Ethnicity and race will be analyzed with a 
logistic regression test with factors of treatment group and analysis center. Past and current 
medical conditions, as well as history of disease, will be presented in data listings. 
12.5 
Protocol Deviations 
All protocol deviations will be reported to the Sponsor and recorded throughout the study. A 
tabulation of protocol deviations will be included in the final study report. 
12.6 
Compliance 
No formal evaluations of compliance are planned. 
12.7 
Interim Analyses 
No interim analyses are planned. 


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12.8 
Additional Statistical Considerations 
12.8.1 Analysis Sets 
Approximately 750 subjects at least 9 years of age and older with moderate or severe acne (a 
score of 3 or 4 [moderate to severe] using the EGSS) will be enrolled and randomized in the 
study. With a1:1:1:1:1 randomization ratio, it is anticipated that: 
• 150 subjects to receive IDP-126 Gel, once daily application 
• 150 subjects to receive IDP-126 Component A Gel, once daily application 
• 150 subjects to receive IDP-126 Component B Gel, once daily application 
• 150 subjects to receive IDP-126 Component C Gel, once daily application  
• 150 subjects to receive IDP-126 Vehicle Gel, once daily application 
The ITT analysis set will consist of all randomized subjects who received study drug. The safety 
analysis set will be comprised of all randomized subjects who are presumed to have used the 
study drug at least once and who provide at least 1 post baseline evaluation. 
An ITT analysis will be conducted on all study subjects. A PP analysis will also be conducted. 
Subjects will be eligible for the PP analysis if they complete the 12-week evaluation without 
noteworthy study protocol violations (i.e., any subject or investigator activity that could have 
possibly interfered with the therapeutic administration of the study drug or the precise evaluation 
of study drug efficacy). The PP analysis set will include subjects in the safety analysis set who 
do not meet any of the following criteria: 
• Failed any of the inclusion/exclusion criteria. 
• Have taken any interfering concomitant medications. 
• Did not attend the Week 12 visit, with the exception of a discontinuation from the study 
due to an AE related to study treatment or documented lack of treatment effect. 
• Missed more than 1 post baseline study visit prior to Week 12. 
• Have not been compliant with the dosing regimen (i.e., subjects may not miss more 
than 5 consecutive days of dosing and must take 80%-120% of expected doses; the 
number of expected doses will be determined for each subject based on the length of 
their participation in the study). 
• Out of visit window at the 12-week visit. 
Prior to breaking the blind, other additional criteria may be added to the list to accommodate for 
unforeseen events that occurred during the conduct of the study that result in noteworthy study 
protocol violations.  
The safety population will be comprised of all randomized subjects who are presumed to have 
used the study medication at least once and who provide at least one post-baseline safety 
evaluation.  


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12.8.2 Sample Size Determination 
The sample size for this study is based on clinical considerations only. No formal sample size 
calculation was performed. A total of approximately 750 randomized subjects are planned for 
this study, including 150 subjects each in the IDP-126 Gel, IDP-126 Component A Gel, IDP-126 
Component B Gel, IDP-126 Component C Gel, and in the IDP-126 Vehicle Gel groups. The 
numbers of subjects in each study drug group are considered adequate to evaluate the safety and 
tolerability of IDP-126 Gel in the treatment of acne vulgaris. 
12.8.3 Handling of Missing Data 
Missing 12 week data will be estimated by MCMC multiple imputation conducted independently 
for each treatment group. The details of this method as well as other methods will be specified in 
the statistical analysis plan, which will be finalized prior to database lock. (see Section 12.1.6). 
12.8.4 Multicenter Issues 
The study will be conducted at multiple study centers in North America with the intention of 
pooling the results for analysis. Every effort will be made to promote consistency in study 
execution at each investigational site. The study is intended to be conducted in a manner such 
that a minimum of 5 subjects will be enrolled in each treatment arm for any investigator. In the 
event that there are too few subjects in a treatment arm for an investigator, then this investigator's 
data will be combined to achieve the desired sample size minimum per arm. The combining of 
investigator's data will be accomplished by taking the investigator with the smallest enrollment 
and combining it with the investigator with the largest. If there is a further need to combine data, 
then the data of the investigator with the second smallest enrollment will be combined with the 
investigator's data which had the second largest enrollment, and so on. This process will continue 
for all investigators who did not have a minimum of 5 subjects per active treatment arm. The 
process of combining investigator data that have insufficient subjects per treatment arm will 
result in redefining the groups of investigators for the purposes of statistical analyses. These 
combined groups will be referred to as "analysis centers" in the statistical analyses based on 
ANCOVA and stratified logistic testing. 
Prior to investigating the treatment effect within the analysis centers, the magnitude of the 
investigational site effect will be investigated to determine if the site-to-site variability is such 
that it could mask the analysis center effects. Change from baseline in inflammatory lesions and 
non-inflammatory lesions will be analyzed with an ANCOVA (unranked or ranked) with factors 
of treatment, investigational site, and treatment by investigational site interaction and the 
respective baseline lesion count variable as a covariate. For the purpose of testing consistency of 
treatment response, the dichotomized EGSS will be analyzed with a logistic regression procedure 
with factors of treatment, investigational site, and treatment by investigational site interaction. 
Investigational sites with low enrollment that interfere with the logistic regression will be 
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The consistency of treatment response will be investigated across the analysis centers subsequent 
to combining the data as described above. Statistical tests will be conducted to identify if there 
are extreme analysis centers that could affect the interpretation of common statistical and clinical 
conclusions. An analysis center by treatment interaction will be included in the primary and 
secondary variable analyses to test for parallel treatment effect at an alpha level of 0.10. Change 
from baseline in inflammatory lesions and non-inflammatory lesions will be analyzed with an 
ANCOVA (unranked or ranked) with factors of treatment, analysis center, and treatment by 
analysis center interaction and the respective baseline lesion count variable as a covariate. For 
the purpose of testing consistency of treatment response, the dichotomized EGSS will be 
analyzed with a logistic regression procedure. Further examination will follow for any variables 
that have a significant ANCOVA or logistic regression interaction term. In the event that the 
ANCOVA or logistic regression interaction (referred to henceforth as the "appropriate test") p-
value is less than or equal to 0.10, a sensitivity analysis that excludes analysis centers with the 
extreme efficacy result will be performed to determine the robustness of the treatment effect. On 
the other hand, if the outcome of the appropriate test has a p-value greater than 0.10, then the 
conclusions from the pooled data will be considered to be free of the impact of extreme analysis 
centers. 
The first step in conducting a sensitivity analysis is to identify the extreme analysis center or 
centers that contribute to the statistical significance of the appropriate test. The process involves 
submitting subsets of analysis centers to the appropriate test and observing the appropriate test p-
value for the subset. Subsets with p-values greater than 0.10 for the appropriate test are 
considered homogeneous. 
The search for an extreme analysis center begins by analyzing all subsets that can be created by 
excluding one analysis center. If one or more of the subsets result in an appropriate test p-value 
greater than or equal to 0.10, then the analysis center excluded from the subset with the largest p-
value for the appropriate test is deemed to be the extreme analysis center. 
If all appropriate test subset p-values are less than or equal to 0.10, then the process will analyze 
the appropriate test for all subsets that can be created by excluding two analysis centers. If one or 
more of these subsets generate appropriate test p-values larger than 0.10, then the analysis 
centers excluded from the subset with the largest appropriate test p-value are deemed the extreme 
analysis centers. 
Thus, the process of identifying the extreme analysis centers will continue in a stepwise manner 
by first excluding one, then two, then three, etc., analysis centers until the appropriate test p-
value exceeds 0.10. Once the extreme analysis center or centers have been identified, then the 
treatment p-values of the remaining analysis centers will be computed. Inferences will be drawn 
from the treatment p-value, as well as any pertinent observations regarding the extreme analysis 
center or centers. 


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12.8.5 Multiplicity Issues 
Not applicable. 
12.8.6 Windowing Rules 
The timing of all study visits is relative to Baseline (Day 0). The Week 2, Week 4, and Week 8 
visits should occur within ± 3 days of the scheduled times, the Week 12 visit should occur within 
−3/+5 days of the scheduled time. 
13 Quality Control and Quality Assurance 
13.1 
Study Monitoring 
An Investigator Meeting and/or an initiation visit will be conducted with the principal 
investigator and study coordinators by the sponsor and/or its designee. During this meeting, an 
extensive review and discussion of the protocol, the roles of the study staff, all study procedures, 
source documents, and eCRFs will be conducted. Evaluation scales will be reviewed extensively 
and documentation of training will be recorded for training of Sponsor-approved evaluators. 
The study monitors/clinical research associates will be trained prior to study initiation. Following 
this training, an overview of the study disease and study material background will be understood. 
Specific monitoring guidelines and procedures to be followed during monitoring visits will also 
be presented. During the course of the study, all data will be 100% source document-verified by 
the monitors. All subject source documents must be made available to the monitors. 
The conduct of the study will be closely monitored by the sponsor following GCP guidelines. 
The reports of these verifications will also be archived with the study report. In addition, 
inspections or on-site audits may be carried out by local authorities or by the Sponsor’s Quality 
Assurance Department. The investigators will allow the Sponsor’s representatives and any 
regulatory agency to examine all study records, corresponding subject medical records, clinical 
dispensing records and storage area, and any other documents considered source documentation. 
The investigators agree to assist the representative, if required. 
13.2 
Audits and Inspections 
The study will be conducted under the sponsorship of Valeant in conformance with all 
appropriate local and federal regulations, as well as ICH guidelines. Interim and end of study 
audits of raw data, study files, and the final report may be conducted by Valeant’s Quality 
Assurance Department or designee. 
The Sponsor is responsible for implementing and maintaining quality assurance and quality 
control systems to ensure that studies are conducted and data are generated, documented, and 
reported in compliance with the protocol, GCP, and applicable regulatory requirements. In 
addition, the sponsor will be responsible for securing agreement from all involved parties to 
ensure direct access to all study related study centers, source data/documents, eCRFs, and reports 


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for the purpose of monitoring and auditing by the Sponsor, and inspection by domestic and 
foreign regulatory authorities. 
13.3 
Data Quality Assurance 
All assessments performed will be accurately documented in the subject’s source documents and 
eCRFs. The investigator or designee will enter the information required by the protocol into the 
source documents and eCRFs provided by the sponsor or designee. Subjects will be identified in 
the eCRFs by their assigned subject number and initials only. 
The investigators must read the protocol thoroughly and must follow the instructions exactly. 
Any deviations should be agreed to by prior discussion between the sponsor and the investigator, 
with appropriate written protocol amendments made prior to implementing the agreed changes. 
Any amendment containing major modifications (particularly if it may involve an increased risk 
to the subjects) will be approved by the IRB before it may be implemented. No change in the 
conduct of the study can be instituted without written approval from the Sponsor. 
14 Ethics and Administrative Issues 
14.1 
Ethical Conduct of the Study 
This study will be conducted in accordance with the ethical principles originating from the 
Declaration of Helsinki, ICH guidelines, GCP, and in compliance with local regulatory 
requirements. The investigator agrees, when signing the protocol, to adhere to the instructions 
and procedures described in it and thereby to adhere to the principles of GCP. 
14.2 
Ethics Review 
This protocol, proposed informed consent/assent form, other information to subjects, and all 
appropriate protocol amendments will be properly reviewed and approved by an IRB or IEC. A 
signed and dated notification of the IRB/IEC approval will be provided to the Sponsor and 
investigator prior to study initiation. The name and occupation of the chairman and members of 
the IRB/IEC will be supplied to the Sponsor. The investigator will provide required progress 
reports and report all SAEs to the IRB/IEC as required by the IRB/IEC. 
14.3 
Written Informed Consent/Assent 
Written informed consent/assent, in accordance with local clinical investigation regulations, must 
be obtained prior to participation in the study.  Subjects less than age of consent must sign an 
assent for the study and a parent or a legal guardian must sign the informed consent (if subject 
reaches age of consent during the study they should be re-consented at the next study visit). 
The investigator or designee will discuss the purpose of the study with each subject, and provide 
a description of the study drug (including any potential and possible side effects) and the study 
procedures. Information must be given both in oral and written forms. Subject information will 
be provided in a language understandable to the subject and may not include any language that 


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appears to waive any of the subject’s legal rights or appears to release the investigator, the 
Sponsor, or the institution from liability or negligence. 
The investigator will provide the prospective subject sufficient time to consider whether or not to 
participate, minimizing the possibility of coercion or undue influence and will discuss any 
questions the subject may have. The investigator will explain to the subject that participation in 
the study is voluntary and that withdrawal from the study is possible at any time without 
detriment to care. The consent must include acknowledgment that medical records and medical 
data derived from the study may be forwarded to the Sponsor or to responsible local or federal 
authorities. 
No subject can enter the study or have any study related procedures performed before his/her 
written informed consent/assent has been obtained. The original signed and dated informed 
consent/assent form will be retained with the study records, and a copy of the signed form will be 
given to the subject. 
An informed consent/assent template will be supplied by the sponsor or designee. Any changes 
to the informed consent/assent form must be agreed to by the sponsor or designee prior to 
submission to the IRB/IEC, and a copy of the approved version must be provided to the sponsor 
or designee after IRB/IEC approval. 
14.4 
Subject Data Protection 
Subject data will be protected by ensuring that no captured data contain subject names, 
addresses, telephone numbers, email addresses, or other direct personally identifying 
information. It is acknowledged that subject initials, demographics (including birthdates), 
medical histories, and prior concomitant medication uses, along with the name and address of the 
enrolling investigator may allow for personal identification of study participants. Other than 
where necessary to meet regulatory requirements, all data collected in this study will be 
presented in tabulated (i.e., aggregate) form and listings containing information that could be 
used to identify an individual subject will not be included in any public disclosures of the study 
data or the study results. 
14.5 
Data Monitoring Committee 
Not applicable. 
14.6 
Financial Disclosure 
Financial disclosures will be obtained from all investigators in order to document any potential 
conflicts of interest. 
14.7 
Investigator Obligations 
The investigator agrees, when signing the protocol, to adhere to the instructions and procedures 
described in it and thereby to adhere to the principles of GCP. 


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14.8 
Changes to the Protocol 
The investigators must read the protocol thoroughly and must follow the instructions exactly. 
Whenever possible, any planned deviations should be agreed to by prior discussion between the 
sponsor and the investigator, with appropriate documentation of sponsor approval prior to 
effecting the changes agreed upon. Any amendment to the protocol containing major 
modifications (particularly if it may involve an increased risk to the subjects) will be approved 
by the IRB before it may be implemented. No change in the conduct of the study can be 
instituted without written approval from the sponsor. 
14.9 
Confidentiality/Publication of the Study 
All the data furnished to the investigator and his/her staff and all data obtained through this 
protocol will be regarded as confidential and proprietary in nature and will not be disclosed to 
any third party, except for the FDA or other regulatory body, without written consent from the 
sponsor. 
15 Data Handling and Record Keeping 
15.1 
Inspection of Records 
Investigators must maintain detailed records on all study subjects who are enrolled in the study 
or undergo screening. Data will be recorded in the subject’s source documents and in applicable 
study logs provided by the Sponsor. Source documents include subject medical records, hospital 
charts, clinic charts, investigator subject study files, as well as the results of diagnostic tests 
(eg, laboratory tests). All required data should be recorded in the study documentation 
completely for prompt data review. Upon study completion or at any other time specified by the 
sponsor or designee, the appropriate study documents must be submitted. 
The investigator must keep accurate separate records (source documentation) of all subject visits, 
being sure to include all pertinent study related information. At a minimum, this includes the 
following information: 
• A statement indicating that the subject has been enrolled in the study and the subject 
number 
• Date that informed consent/assent was obtained 
• Evidence that the subject meets study eligibility requirements (eg, medical history, 
screening evaluations) 
• Dates of all study related visits and results of any evaluations/procedures performed, 
including who performed each assessment at each visit 
• Use of any concurrent medications during the study 
• Documentation of study drug accountability 


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• Any and all side effects and AEs must be thoroughly documented to conclusion 
• Results of any diagnostic tests conducted during the study 
• The date the subject exited the study and a statement indicating that the subject 
completed the study or was discontinued early, including the reason for 
discontinuation 
Notes describing telephone conversations and all electronic mail with the subject or the sponsor 
(sponsor’s designee) concerning the study must be recorded or kept on file. All source 
documents must be made available to the sponsor and the sponsor’s designated monitor upon 
request. 
15.2 
Retention of Records 
The investigator should properly store and maintain all study records in accordance with sponsor 
directives. All records relating to the conduct of this study are to be retained by the investigator 
until notified by the sponsor in writing that the records may be destroyed. 
The investigator will allow representatives of the sponsor’s monitoring team, the governing 
IRB/IEC, the FDA, and other applicable regulatory agencies to inspect all study records, eCRFs, 
and corresponding portions of the subject’s clinic and/or hospital medical records at regular 
intervals throughout the study. These inspections are for the purpose of verifying adherence to 
the protocol, completeness and accuracy of the data being entered onto the eCRF, and 
compliance with FDA or other regulatory agency regulations. 
 
 


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16 References 
1. Bikowski J, Callender V, Del Rosso J, Draelos Z, Tanghetti E. Combining clindamycin 1%-
benzoyl peroxide 5% gel with multiple therapeutic options. Cutis. 2006;78(2 Suppl 1):13-20. 
2. Bowman S, Gold M, Nasir A, Vamvakias G. Comparison of clindamycin/benzoyl peroxide, 
tretinoin plus clindamycin, and the combination of clindamycin/benzoyl peroxide and 
tretinoin plus clindamycin in the treatment of acne vulgaris: a randomized, blinded study. J 
Drugs Dermatol. 2005;4(5):611-8. 
3. Burkhart CG, Burkhart CN. The chemistry and synergy of benzoyl peroxide with 
clindamycin. Br J Dermatol. 2008;159(2):480-1. 
4. Del Rosso JQ. Study results of benzoyl peroxide 5%/clindamycin 1% topical gel, adapalene 
0.1% gel, and use in combination for acne vulgaris. J Drugs Dermatol. 2007;6(6):616-22. 
5. Dosik JS, Homer K, Arsonnaud S. Cumulative irritation potential of adapalene 0.1% cream 
and gel compared with tazarotene cream 0.05% and 0.1%. Cutis. 2005a;75(5):289-93. 
6. Dosik JS, Homer K, Arsonnaud S. Cumulative irritation potential of adapalene 0.1% cream 
and gel compared with tretinoin microsphere 0.04% and 0.1%. Cutis. 2005b;75(4):238-43. 
7. Ghali F, Kang S, Leyden J, Shalita AR, Thiboutot DM. Changing the face of acne therapy. 
Cutis. 2009;83(2 Suppl):4-15. 
8. Gollnick H, Cunliffe W, Berson D, Dreno B, Finlay A, Leyden JJ, et al. Management of 
acne: a report from a Global Alliance to Improve Outcomes in Acne. J Am Acad Dermatol. 
2003;49(1 Suppl):S1-37. 
9. Goodman G. Acne--natural history, facts and myths. Aust Fam Physician. 2006;35(8):613-6. 
10. Harper JC. Benzoyl peroxide development, pharmacology, formulation and clinical uses in 
topical fixed-combinations. J Drugs Dermatol. 2010;9(5):482-7. 
11. Kircik L. Community-based trial results of combination clindamycin 1%--benzoyl peroxide 
5% topical gel plus tretinoin microsphere gel 0.04% or 0.1% or adapalene gel 0.1% in the 
treatment of moderate to severe acne. Cutis. 2007;80(1 Suppl):10-4. 
12. Krakowski AC, Stendardo S, Eichenfield LF. Practical considerations in acne treatment and 
the clinical impact of topical combination therapy. Pediatr Dermatol. 2008;25 Suppl 1:1-14. 
13. Nast A, Dreno B, Bettoli V, Degitz K, Erdmann R, Finlay AY, et al. European evidence-
based (S3) guidelines for the treatment of acne. J Eur Acad Dermatol Venereol. 
2012;26(Suppl 1):1-29. 
14. Piskin S, Uzunali E. A review of the use of adapalene for the treatment of acne vulgaris. Ther 
Clin Risk Manag. 2007;3(4):621-4. 


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15. Shalita A. The integral role of topical and oral retinoids in the early treatment of acne. J Eur 
Acad Dermatol Venereol. 2001;15(Suppl 3):43-9. 
16. Tanghetti E, Abramovits W, Solomon B, Loven K, Shalita A. Tazarotene versus tazarotene 
plus clindamycin/benzoyl peroxide in the treatment of acne vulgaris: a multicenter, double-
blind, randomized parallel-group trial. J Drugs Dermatol. 2006;5(3):256-61. 
17. Tanghetti E, Popp K. A current review of topical benzoyl peroxide: new perspectives on 
formulation and utilization. Dermatol Clin. 2009;27(1):17-24. 
18. Thiboutot D, Gollnick H, Bettoli V, Dreno B, Kang S, Leyden JJ, et al. New insights into the 
management of acne: an update from the Global Alliance to Improve Outcomes in Acne 
group. J Am Acad Dermatol. 2009;60(5 Suppl):S1-50. 
19. Thielitz A, Gollnick H. Recent therapeutic developments for acne. Expert Review of 
Dermatology. 2013;8(1):37-50. 
20. Webster GF. Acne vulgaris. BMJ. 2002;325(7362):475-9. 
21. Weiss J, Shavin J. Topical retinoid and antibiotic combination therapy for acne management. 
J Drugs Dermatol. 2004;3(2):146-54. 
22. White GM. Recent findings in the epidemiologic evidence, classification, and subtypes of 
acne vulgaris. J Am Acad Dermatol. 1998;39(2 Pt 3):S34-7. 
23. Zaenglein AL. Topical retinoids in the treatment of acne vulgaris. Semin Cutan Med Surg. 
2008;27(3):177-82. 
24. Zar, JH.  Biostatistical analysis.  2nd Edition.  Englewood Cliffs, NJ: Prentice-Hall. P. 118 - 
119. 1984 
 
 
 
 
 
 
 
 
 
 
 
 


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17 Appendices 
17.1 
Subject Instruction Sheet 
Wash your face gently with a mild cleanser approved by your study doctor and warm (not hot) 
water. Rinse thoroughly and gently pat dry with a cotton towel. Wait until skin is completely dry 
before applying the study drug. 
A thin layer of study drug should be applied once daily in the evening, at least 30 minutes prior 
to bed time (about the same time every day) to the entire face for twelve weeks.  Use the pump to 
dispense one pea-sized amount of study drug onto your fingertip (Figure 1).  One pea-sized 
amount of study drug should be enough to cover your entire face. 
 
 
 
 
This dose should then be dotted on to 6 areas (chin, left cheek, right cheek, nose, left forehead, 
right forehead) on the face (Figure 2). After distributing the dose in this manner, gently rub the 
gel into the skin. This amount should be used to evenly cover the entire face excluding the 
mouth, eyes and lips. It is important to treat your entire face. 
                                                          
 
 
Do NOT treat only specific lesions. DO NOT APPLY MORE THAN THE PRESCRIBED 
AMOUNT.  Do NOT share your study drug with anybody, study drug is for your use only and 
will be weighed during your study visits to review the amount of study drug you have used. 
Be sure to wash your hands after you apply the product. 
Reminders: 


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• On study visit days, study drug will be applied at your study center during the visit. On 
the day of the visit, do not apply study drug prior to your study visit or in the evening 
after your study visit. 
• Avoid contact with the eyes, inside the nose, mouth and all mucous membranes. Caution: 
This product contains benzoyl peroxide which can bleach hair or colored fabric. 
• Do not cover the affected areas with any type of dressing, such as gauze.  
• THE STUDY DRUG SHOULD BE USED ONLY BY THE PERSON FOR WHOM IT 
WAS PRESCRIBED and it should be kept out of the reach of children or others of 
limited capacity to read or understand. 
• Store this at room temperature up to 25°C (77°F). Do not freeze. Avoid excessive heat or 
cold. 
• Containers of study drug must be returned to the study facility, even if they are empty. 
• If you miss any doses, at your next visit inform the study doctor of the date(s) of the 
missed dose(s). 
• Continue to use the same, study doctor approved, cleanser, moisturizer and sunscreen 
throughout the study. 
• You must not use any other treatment for your facial acne while you are participating in 
this study. 
• Avoid unnecessary sun exposure and tanning booths. 
It is important that you inform the study center about any medications (i.e., prescriptions, over-
the-counter medications, street drugs, or herbal medications) that you have taken during the 
study. 
If you experience significant diarrhea while participating in the study contact the Study Doctor 
immediately. 
If you have any questions or have a potential research-related side effect or injury you may 
contact ________________________ at _________________. 
 


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17.2 
Cleansers, Moisturizers and Sunscreen Use Guidelines 
Subjects may use the following products as examples of approved products. The Investigator 
may use their discretion on what products each subject may use in the treatment area during the 
study. Subjects may use the below set of examples or other Investigator approved non-medicated 
products on the treatment area. Information regarding products used should be captured in the 
source document and recorded on the facial skin care section of the eCRF. 
 
Approved Cleanser Examples: 
• CeraVe cleanser 
• Cetaphil daily cleaner and gentle cleansing bar 
• Purpose gentle cleansing wash 
 
Approved Moisturizer Examples: 
• CeraVe Cream or Lotion 
• Moisturel cream or lotion 
• Nutraderm 
• Cetaphil lotion or cream 
• DML 
• Eucerin lotion or cream 
• Purpose 
 
Approved Moisturizer/Sunscreen Combination Product Examples: 
• CeraVe Lotion AM 
• Olay Complete (SPF 15) 
• Neutrogena Health Defense Daily Moisturizer (SPF 30) 
• Cetaphil Daily Facial Moisturizer (SPF 15) 
 
Approved Sunscreen Examples: 
• Banana Boat Sport Sunblock Lotion (SPF 15, 30+ or 50) 
• Neutrogena UVA/UVB (SPF 30 or 45) 
• Neutrogena Sensitive Skin Sunblock Lotion (SPF 17) 
• Neutrogena Healthy Defense Oil-Free Sunblock Lotion (SPF 30 or 45) 
• Coppertone Water Babies UVA/UVB Sunblock Lotion (SPF 45) 
 
 
 
 


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