Evaluation of the Safety and Efficacy of an Acne Treatment Device
Phase: NA
Conditions: Mild to Moderate Acne
Sponsor: ZIIP Beauty

 
 
Dermatology Consulting Services, PLLC 
 
PAGE 1 of 28 
 
 
Zoe Diana Draelos, MD 
 
 
 
ZIIP Acne Protocol 
October 5, 2020 
 
Evaluation of the Safety and Efficacy of an Acne Treatment 
Device 
 
STUDY NUMBER 
 
 
DCS-46-20 
INVESTIGATOR 
 
Zoe Diana Draelos, MD 
STUDY SITE 
 
Dermatology Consulting Services, PLLC 
2444 North Main Street 
High Point, NC, 27262 
T 336-841-2040  F 336-841-2044 
zdraelos@northstate.net 
 
INSTITUTIONAL REVIEW BOARD 
 
Allendale Institutional Review Board 
(AIRB) 
30 Neck Road 
Old Lyme, CT 06371 
T 860-434-5872  F 860-434-5892 
 
SPONSOR 
 
ZIIP Inc. 
INVESTIGATIONAL DEVICE 
 
ZIIP Device 
SPONSOR PRIMARY CONTACT 
 
Jamie Rosen 
STUDY DESIGN 
 
Monadic device, historical control 
VERSION NUMBER 
 
6 
 
 
This document is confidential and contains proprietary information of Dermatology 
Consulting Services, PLLC.  Neither this document nor any information contained herein 
can be reproduced or disclosed to others without written consent of Dermatology 
Consulting Services, PLLC. 
 

 
 
Dermatology Consulting Services, PLLC 
 
PAGE 2 of 28 
 
 
Zoe Diana Draelos, MD 
 
PROTOCOL NUMBER: DCS-46-20 
 
STUDY TITLE: Evaluation of the Safety and Efficacy of an Acne Treatment Device 
 
PROTOCOL SYNOPSIS AND BUDGET DATE: August 1, 2020 
 
PROTOCOL DATE: October 5, 2020 
 
ANTICIPATED STUDY RUN DATES: TBD 
 
ANTICIPATED FINAL REPORT DATE: TBD 
 
 
This document represents the final approved protocol ready for IRB submission. 
 
 
 
 
 
________________________________ 
____________ 
Representative 
Date 
ZIIP 
 
 
 
________________________________ 
____________ 
Zoe Diana Draelos, M.D. 
 
 
 
Date 
Primary Investigator 
Dermatology Consulting Services, PLLC 
 
 
 

 
 
Dermatology Consulting Services, PLLC 
 
PAGE 3 of 28 
 
 
Zoe Diana Draelos, MD 
 
STUDY NUMBER 
1 
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Zoe Diana Draelos, MD 
 
11.2 
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INVESTIGATOR’S AGREEMENT 
28 
 
 

 
 
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PAGE 5 of 28 
 
 
Zoe Diana Draelos, MD 
 
1. 
PROTOCOL SYNOPSIS 
 
Title of Study: 
Evaluation of the Safety and Efficacy of an Acne Treatment Device 
Study Period: 
12 weeks 
Test Device 
and 
Application 
Instructions: 
ZIIP Device (active) 
-400 microamps direct current, applied 3 days per week on non-consecutive days, 
on all areas afflicted by acne  The following instructions will be provided: 
1. Both silver probes must come in contact with skin throughout treatment. 
2. Slowly make continuous circles with the top probe (the one farthest away from the 
charging port) over acne within each facial zone. 
**NOTE: Instructional video will be provided for participants to follow** 
3. Treat each facial zone for 1 minute.  Your device will beep and vibrate at the one 
minute mark to indicate that treatment of that zone is complete.  Only treat the acne 
zone(s) identified for treatment. 
4. After treatment, wipe your device clean with a tissue, being careful to avoid the 
charging port. Spray the device and a second tissue lightly with rubbing alcohol and 
wipe again, remaining careful to avoid the charging port. 
5. Store safely away from water, moisture or debris. 
 
Ancillary 
Product and 
Application 
Instructions: 
Electroconductive Media 
Apply as a thin layer to all facial areas afflicted with acne 
Objective: 
The objective of this study is to demonstrate the safety and efficacy of a novel direct 
current device employed in the treatment of mild to moderate inflammatory acne 
after 12 weeks of every other day use. 
 
Design: 
 
 
 
Male and female subjects will be enrolled in this single-site monadic study to 
evaluate the effect of a device on acne treatment.  Subjects who sign the consent form 
and meet all inclusion criteria and none of the exclusion criteria will be enrolled at 
the baseline visit.  Subjects will be asked to continue use of their self-selected 
moisturizer, non-medicated cleanser, and sunscreen they have used without difficulty 
for the prior 30 days and for the 12-week study.  Subjects must also continue all 
facial products and cosmetics unchanged for the duration of the study.  No other oral 
or topical acne products can be used.  Subjects must be washed out of all topical acne 
products for at least 2 weeks and all oral acne products for at least 4 weeks prior to 
study participation.  Subjects must possess mild to moderate acne with 5-30 
inflammatory lesions and no nodules/cysts. 
 
At baseline visit, subjects will receive the study acne device to be applied to the areas 
of the face afflicted by acne following cleansing, every other day.  The dermatologist 
investigator will assess the face for the investigator global acne assessment (IGA) 
based on the following 5 point ordinal scale: 0=clear, 1=almost clear, 2=mild, 
3=moderate, and 4=severe.  In addition, the dermatologist investigator will perform 

 
 
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PAGE 6 of 28 
 
 
Zoe Diana Draelos, MD 
 
an inflammatory and non-inflammatory lesion count.  The dermatologist investigator 
will assess the tolerability of the device in terms of peeling, dryness, redness, and 
swelling on a 5-point ordinal scale (0=none, 1=minimal, 2=mild, 3=moderate, & 
4=severe). 
 
The subjects will assess device tolerability in terms of itching, burning, redness, and 
swelling.  All assessments will be made on a 5-point ordinal scale (0=none, 
1=minimal, 2=mild, 3=moderate, & 4=severe).  Subjects will be given their diaries, 
study device, and electroconductive media and asked to return to the research center 
in 2 weeks.  A reminder text will be sent to encourage compliance prior to the week 2 
visit. 
 
Subjects will return to the research center at week 2, week 4, and week 8 for the same 
study activities as conducted at baseline.  However, in addition a subject self-
assessment marketing questionnaire provided by the sponsor will be administered.  
Subject diaries will be checked at each return visit for compliance and completion.  
Subjects will be re-dispensed electroconductive media as needed at each visit; and 
the devices will be inspected for continued functionality.  Reminder texts will be sent 
prior to each visit to encourage compliance. 
 
Subjects will return to the research center at week 12 for the same study activities as 
conducted at baseline.  Study diaries and devices will be checked and collected.  
Subjects will terminate their study participation at this time. 
 
All investigator selected subjects will be photographed with the Canfield VISIA CR 
using Standard 1 lighting at baseline, week 2, week 4, and week 8, and week 12. 
 
Subjects will be provided with the following device instructions: 
 
1. Begin with clean, dry skin. 
2. Inspect your skin and identify which zones of your face have acne. The four facial 
zones are divided as follows: 1) Upper Left, 2) Upper Right, 3) Lower Left, and 4) 
Lower Right. The zone(s) identified now will be treated throughout the study. 
3. Liberally apply the conductive gel provided to you over each zone which has acne. 
4. Turn on your device by pressing the button at the top. You will hear one beep. 
5. Place the device on your skin. Lights will illuminate under the device when both 
silver probes come in contact with your skin. Both probes must keep contact with 
skin throughout treatment. 
6. Slowly make continuous circles with the top probe (the one farthest away from the 
charging port) over acne within each facial zone. (You may feel a tingling sensation 
during treatment. That is normal.) 
7. Treat each facial zone for 1 minute.  Your device will beep and vibrate at the one 
minute mark to indicate that treatment of that zone is complete.  Only treat the acne 
zone(s) identified for treatment. 
8. At the end of treatment, your device will beep twice and turn off. 

 
 
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Zoe Diana Draelos, MD 
 
9. After treatment, wipe your device clean with a tissue, being careful to avoid the 
charging port. Spray the device and a second tissue lightly with rubbing alcohol and 
wipe again, remaining careful to avoid the charging port. 
10. Store safely away from water, moisture or debris. After treatment, wipe your 
device clean with a tissue before putting it away. 
11. Repeat treatment of the original acne zone(s) through the study. Perform 
treatments every other day for 12 weeks. 
12. If any new areas of acne develop later in the study, you may also treat those 
additional zones until study completion. For example, if you have acne in the 
forehead and mouth zones at the start of the study, treat those two zones for every 
treatment. If additional acne develops on the left cheek later in the study, treat the left 
cheek zone in addition to the mouth and forehead zones for all remaining treatments 
 
CHARGING: 
When you see the orange light flashing while using your device, it’s time to charge. 
To charge, plug in the charging cable provided. The orange light will remain 
illuminated while charging. You will know that your device is completely charged 
when the orange light is no longer on. 
 
CONTRAINDICATIONS 
ZIIP should not be used in the following areas 
- Breast area 
- Directly on top of the eyelid 
- Midline of neck (bone of neck) 
- Groin area 
- Do not use this device on patients who have a cardiac pacemaker, implanted 
defibrillator, or other implanted metallic or electronic device because this may cause 
electric shock 
 
WARNINGS 
Do not submerge the device in water or any other liquid(s). If you store your ZIIP in 
an area such as a bathroom counter, ensure the product does not come in contact with 
water or other liquid(s). 
 
ZIIP should not be used by: 
• Children 
• Pregnant Women 
• People subject to seizures 
• People with cancer/tumors 
• People with a cardiac pacemaker 
• People with implanted defibrillators/stimulators 
• People with electronic implanted devices 
 
If you have any medical concerns, such as a severe medical illness, epilepsy or 
seizures, or recent facial surgery, please consult your doctor before using ZIIP. 
 

 
 
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Zoe Diana Draelos, MD 
 
Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not 
operate properly when a ZIIP device is in use. 
 
Stimulation should not be applied over, or in proximity to cancerous lesions, or 
applied over swollen, infected, or inflamed areas or skin eruptions, e.g., phlebitis, 
thrombophlebitis, broken capillaries, varicose veins, etc. Men should shave before 
use as hair can interfere with the conductivity of the electrodes. Facial area under a 
beard or mustache cannot be treated. 
 
Do not apply stimulation across your chest as the introduction of electrical current 
into the chest may cause rhythm disturbances to your heart, which could be lethal. 
 
The long-term effects of stimulation are not known. 
 
(There is an allowance for an unscheduled visit at any time, if necessary.)  
Study 
Population: 
Healthy male and female subjects 18-50 years of age of all Fitzpatrick skin types 
with mild to moderate acne consisting of 5-30 inflammatory lesions and no 
nodules/cysts. 
Number of 
Patients: 
50 subjects 
Inclusion 
Criteria: 
1. Subjects with mild to moderate acne (5-30 inflammatory lesions and no 
nodules/cysts). 
2. Male and female subjects age 18-50 years. 
3. Subjects with all Fitzpatrick skin types. 
4. Subjects of all complexion types (normal, oily, dry, combination). 
5. Subjects who have used the same moisturizer without difficulty for 30 days 
and will continue using same moisturizer during the 12-week study. 
6. Subjects agree not to introduce any new colored cosmetics (lipsticks, eye 
shadows, facial foundations, blush, or powder). 
7. Subjects who are using no other acne products for the duration of the study. 
8. No known medical conditions that, in the investigator’s opinion, may 
interfere with study participation. 
9. Women of childbearing potential must be willing to use a form of birth 
control during the study.  For the purpose of this study, the following are 
considered acceptable methods of birth control: oral contraceptives, 
Norplant®, Depo-Provera®, double barrier methods (e.g., condom and 
spermicide) and abstinence. 
10. Subjects have signed an Informed Consent Form in compliance with 21CFR, 
Part 50: "Protection of Human Subjects." 
11. Subjects are dependable and able to follow directions and willing to comply 
with the schedule of visits. 
12. Subjects in generally good physical and mental health. 
 
Exclusion 
Criteria: 
1. Any dermatological disorder, which in the investigator’s opinion, may interfere 
with the accurate evaluation of the subject's skin characteristics, except for the 
study condition of acne. 

 
 
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Zoe Diana Draelos, MD 
 
2. Subjects who are not willing to use the assigned study device to their face as 
instructed. 
3. Subjects who have used any topical prescription or OTC acne products for 2 
weeks prior to study entry. 
4. Subjects who have taken any oral prescription or OTC acne products for 4 weeks 
prior to study entry. 
5. Subjects who have used a non-OTC cleanser without benzoyl peroxide, sulfur or 
salicylic acid for at least 2 weeks prior to study entry. 
6. Subject who have not had any facial treatments in the past 6 months and are 
willing to withhold all facial treatments during the course of the study including 
facials, facial peels, photo facials, laser treatments, dermabrasion, botulinum 
toxin (Botox), injectable filler treatments, intense pulsed light (IPL), acid 
treatments, tightening treatments, and/or facial plastic surgery. 
7. Subjects who are pregnant, breast feeding or planning a pregnancy. 
8. Subjects with clinically significant and/or unstable medical disorders. 
9. Subjects who are unwilling or unable to comply with the requirements of the 
protocol.  
10.  Subjects who have a history of a psychological illness or condition that would 
interfere with their ability to understand and follow the requirements of the study. 
11. Subjects who have undergone recent facial surgery. 
12. Subjects currently participating in any other clinical trial. 
13. Subjects having started hormone replacement therapies (HRT) or hormones for 
birth control less than 3 months prior to the study entry; or who plan on starting, 
stopping or changing doses of HRT or hormones for birth control during the 
study. 
14. Subjects who have a cardiac pacemaker, implanted defibrillator, or other 
implanted metallic or electronic device. 
15. Subjects who are wearing EKG monitoring equipment. 
16. Subjects with phlebitis, thrombophlebitis, broken capillaries, or varicose veins. 
17. Subjects who have seizures, epilepsy, or cancer/tumors. 
18. Subjects who have a history of hypertrophic scarring or keloid formation. 
 
Endpoints: 
Tolerability Endpoint: 
The tolerability endpoint is the investigator-assessed absence of skin irritation from 
the facial study device at any time during the 12-week study. 
 
Safety Endpoint: 
The safety endpoint is the overall incidence of all adverse events reported during the 
study. 
 
Efficacy Endpoint: The efficacy endpoint is the investigator assessed improvement in 
investigator global assessment (IGA) after 12 weeks of every other day device use as 
compared to baseline. 
 
Measures: 
Dermatologist Investigator assessed efficacy parameters: Investigator global acne 
assessment (IGA) based on the following 5 point ordinal scale: 0=clear, 1=almost 

 
 
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Zoe Diana Draelos, MD 
 
clear, 2=mild, 3=moderate, and 4=severe. IGA assessments will be conducted at 
baseline, week 2, week 4, week 8, and week 12. 
 
Dermatologist Investigator lesion counts: inflammatory lesion count (papules, 
pustules), non-inflammatory lesion count (open comedones, closed comedones). 
Lesion counts will be conducted at baseline, week 2, week 4, week 8, and week 12. 
 
Dermatologist Investigator assessed tolerability parameters: peeling, dryness, 
redness, and swelling. All assessments will be made on a 5-point ordinal scale 
(0=none, 1=minimal, 2=mild, 3=moderate, & 4=severe) at baseline, week 2, week 4, 
week 8, and week 12. 
 
Self-assessment questionnaire:  To be provided by sponsor.  All assessments will be 
at week 2, week 4, and week 8, and week 12. 
 
Subject assessed tolerability parameters: itching, burning, redness, and swelling. All 
assessments will be made on a 5-point ordinal scale (0=none, 1=minimal, 2=mild, 
3=moderate, & 4=severe) at baseline, week 2, week 4, and week 8, and week 12. 
 
Photography: all investigator selected subjects will be photographed with the 
Canfield VISIA CR using Standard 1 lighting at baseline, week 2, week 4, and week 
8, and week 12. 
 
Statistical 
Methods: 
 
 
Along with descriptive statistics (means, standard deviations and percentages), 
investigator and subject ordinal nonparametric data will be analyzed using the 
Wilcoxon signed rank test.  Acne lesion counts will be assessed using a Student t test.  
Change will be considered significant at a p value of less than or equal to 0.05. 
 

 
 
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Zoe Diana Draelos, MD 
 
2. 
STUDY VISIT SCHEDULE 
 
Procedures 
Visit 1 
 
Visit 2 
Visit 3 
 
Visit 4 
 
Visit 5 
 
BL 
Week 
2 
Week 
4 
Week 
8 
Week 
12 
Informed Consent 
Procedure 
X 
 
 
 
 
Inclusion/Exclusion 
Criteria 
X 
 
 
 
 
Brief Medical History 
and Concomitant 
Medications Review 
X 
X 
X 
X 
X 
Investigator Clinical 
Grading for Tolerability 
X 
X 
X 
X 
X 
Investigator Clinical  
Facial Grading (IGA) 
X 
X 
X 
X 
X 
Investigator Acne Lesion 
Counts 
X 
X 
X 
X 
X 
Subject Clinical Grading 
for Tolerability 
X 
X 
X 
X 
X 
Subject Self Assessment 
Questionnaire 
 
X 
X 
X 
X 
Photography 
X 
X 
X 
X 
X 
Dispense 
electroconductive media  
X 
X 
X 
X 
 
Device Check/Dispensing 
X 
X 
X 
X 
 
Subject Diary Assessment 
and Compliance Check 
 
X 
X 
X 
X 
Subject Device 
Accountability and Study 
Completion 
 
 
 
 
X 
 
 
   
 
 
 

 
 
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Zoe Diana Draelos, MD 
 
3. 
INTRODUCTION 
Acne is a disease that affects individuals of all ages. 85% of Americans 12-24 years of 
age have acne and epidemiological studies show a similar prevalence in other countries.  
The etiology of acne is multifaceted, involving abnormal follicular hyperkeratizination, 
increased sebum production; follicular colonization by C. acnes, and inflammation.  
Hyperkeratinization induced microcomedone formation is the first step in acne lesion 
formation.  As keratinocytes and sebum continue to accumulate, a visible non-
inflammatory comedone lesion forms. The continued proliferation of C. acnes within the 
follicle results in follicular wall rupture and eventual formation of an inflammatory 
papule or pustule.  Successful treatment of acne involves interrupting this sequence of 
events.  This research examines the ability of a novel device to treat acne. 
 
4. 
STUDY OBJECTIVE 
The objective of this study is demonstrate the safety and efficacy of a novel direct current 
device in the treatment of mild to moderate inflammatory acne after 12 weeks of every 
other day use. 
 
5. 
STUDY DESIGN OVERVIEW 
Male and female subjects will be enrolled in this single-site monadic study to evaluate the 
effect of a direct-current device on acne treatment.  Subjects who sign the consent form 
and meet all inclusion criteria and none of the exclusion criteria will be enrolled at the 
baseline visit.  Subjects will be asked to continue their self-selected moisturizer, non-
medicated cleanser, and sunscreen they have used without difficulty for the prior 30 days 
and for the 12 week study.  Subjects must also continue all facial products and cosmetics 
unchanged for the duration of the study.  No other oral or topical acne products can be 
used.  Subjects must be washed out of all topical acne products for at least 2 weeks and 
all oral acne products for at least 4 weeks.  Subjects must possess mild to moderate acne 
with 5-30 inflammatory lesions and no nodules/cysts. 
 
At baseline visit, subjects will receive the study acne device to be applied to the areas of 
the face afflicted by acne following cleansing, every other day.  The dermatologist 
investigator will assess the face for the investigator global acne assessment (IGA) based 
on the following 5 point ordinal scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, and 
4=severe.  In addition, the dermatologist investigator will perform an inflammatory and 
non-inflammatory lesion count.  The dermatologist investigator will assess the 
tolerability of the device in terms of peeling, dryness, redness, and swelling on a 5-point 
ordinal scale (0=none, 1=minimal, 2=mild, 3=moderate, & 4=severe). 
 
The subjects will assess device tolerability in terms of itching, burning, redness, and 
swelling.  All assessments will be made on a 5-point ordinal scale (0=none, 1=minimal, 
2=mild, 3=moderate, & 4=severe).  Subjects will be given their diaries, study device, and 
electroconductive media and asked to return to the research center in 2 weeks.  A 
reminder text will be sent to encourage compliance prior to the week 2 visit. 
 

 
 
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Zoe Diana Draelos, MD 
 
Subjects will return to the research center at week 2, week 4, and week 8 for the same 
study activities as conducted at baseline.  However, in addition, a subject self-assessment 
marketing questionnaire provided by the sponsor will be administered.  Subject diaries 
will be checked at each return visit for compliance and completion.  Subjects will be re-
dispensed electroconductive media gel at each visit and the devices will be inspected for 
any problems.  Reminder texts will be sent prior to each visit to encourage compliance. 
 
Subjects will return to the research center at week 12 for the same study activities as 
conducted at baseline.  Study diaries and devices will be checked and collected.  Subjects 
will terminate their study participation at this time. 
 
20 investigator selected subjects will be photographed with the Canfield VISIA CR using 
Standard 1 lighting at baseline, week 2, week 4, and week 8, and week 12. 
 
6. 
STUDY POPULATION 
6.1 
NUMBER OF SUBJECTS 
50 subjects enrolled 
 
6.2 
SUBJECT CHARACTERISTICS 
Healthy male and female subjects 18-50 years of age of all Fitzpatrick skin types with 
mild to moderate acne consisting of 5-30 inflammatory lesions and no nodules/cysts 
 
6.3 
INCLUSION CRITERIA 
The following items represent the inclusion criteria: 
1. Subjects with mild to moderate acne (5-30 inflammatory lesions and no 
nodules/cysts). 
2. Male and female subjects age 18-50 years. 
3. Subjects with all Fitzpatrick skin types. 
4. Subjects of all complexion types (normal, oily, dry, combination). 
5. Subjects who have used the same moisturizer without difficulty for 30 days and 
will continue using same moisturizer during the 12 week study. 
6. Subjects agree not to introduce any new colored cosmetics (lipsticks, eye 
shadows, facial foundations, blush, & powder). 
7. Subjects who are using no other acne products for the duration of the study. 
8. No known medical conditions that, in the investigator’s opinion, may interfere 
with study participation. 
9. Women of childbearing potential must be willing to use a form of birth control 
during the study.  For the purpose of this study, the following are considered 
acceptable methods of birth control: oral contraceptives, Norplant®, Depo-
Provera®, double barrier methods (e.g., condom and spermicide) and abstinence. 
10. Subjects have signed an Informed Consent Form in compliance with 21CFR, Part 
50: "Protection of Human Subjects." 
11. Subjects are dependable and able to follow directions and willing to comply with 
the schedule of visits. 

 
 
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PAGE 14 of 28 
 
 
Zoe Diana Draelos, MD 
 
12. Subjects in generally good physical and mental health. 
 
 
6.4 
EXCLUSION CRITERIA 
The following items represent the exclusion criteria: 
1. Any dermatological disorder, which in the investigator’s opinion, may interfere 
with the accurate evaluation of the subject's skin characteristics, except for the 
study condition of acne. 
2. Subjects who are not willing to use the assigned study device to their face as 
instructed. 
3. Subjects who have used any topical prescription or OTC acne products for 2 
weeks prior to study entry. 
4. Subjects who have taken any oral prescription or OTC acne products for 4 weeks 
prior to study entry. 
5. Subjects who have used a non-OTC cleanser without benzoyl peroxide, sulfur or 
salicylic acid for at least 2 weeks prior to study entry. 
6. Subject who have not had any facial treatments in the past 6 months and are 
willing to withhold all facial treatments during the course of the study including 
facials, facial peels, photo facials, laser treatments, dermabrasion, botulinum toxin 
(Botox), injectable filler treatments, intense pulsed light (IPL), acid treatments, 
tightening treatments, and/or facial plastic surgery. 
7. Subjects who are pregnant, breast feeding or planning a pregnancy. 
8. Subjects with clinically significant and/or unstable medical disorders. 
9. Subjects who are unwilling or unable to comply with the requirements of the 
protocol.  
10. Subjects who have a history of a psychological illness or condition that would 
interfere with their ability to understand and follow the requirements of the study. 
11. Subjects who have undergone recent facial surgery. 
12. Subjects currently participating in any other clinical trial. 
13. Subjects having started hormone replacement therapies (HRT) or hormones for 
birth control less than 3 months prior to the study entry; or who plan on starting, 
stopping or changing doses of HRT or hormones for birth control during the 
study. 
14. Subjects who have a cardiac pacemaker, implanted defibrillator, or other 
implanted metallic or electronic device. 
15. Subjects who are wearing EKG monitoring equipment. 
16. Subjects with phlebitis, thrombophlebitis, broken capillaries, or varicose veins. 
17. Subjects who have seizures, epilepsy, or cancer/tumors. 
18. Subjects who have a history of hypertrophic scarring or keloid formation. 
 
 
 

 
 
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Zoe Diana Draelos, MD 
 
6.5 
CONCOMITANT MEDICATIONS 
All oral and topical prescription medications should remain unchanged during the study.  
No oral or topical over the counter or prescription acne medications are allowed.  No 
other acne products other than the study products are allowed during the study. 
 
7. 
CONDUCT OF STUDY: METHODS AND PROCEDURES 
7.1 
ENROLLMENT  
7.1.1 INFORMED CONSENT 
A signed informed consent form shall be obtained from each subject prior to 
study enrollment and performing any study procedures.  No study related 
procedures or activities shall be performed until each subject is fully informed 
and the consent form is signed and dated. 
 
7.1.2 MEDICAL HISTORY  
An abbreviated medical history including current medications shall be 
recorded. 
 
7.1.3 DERMATOLOGICAL EXAMINATION 
A dermatological examination shall be performed to insure subjects possess 
acne and meet all inclusion criteria and none of the exclusion criteria. 
 
7.1.4 STUDY PROCEDURES  
The subjects will be screened for the inclusion and exclusion criteria prior to 
study enrollment.  Only subjects who meet all the requirements, have signed 
an informed consent, and have given a medical history shall be entered into 
the study.  All other subjects shall be considered screening failures. 
 
7.1.5 STUDY MATERIAL ADMINISTRATION  
All subjects will use the active ZIIP device as currently marketed.  The ZIIP 
Device will be customized for the delivery of acne treatment with -400 
microamps direct current, applied 3 days per week on non-consecutive days, 
on each facial zone afflicted by acne.  A electroconductive media will be 
applied to each facial zone afflicted by acne prior to initiation of the device 
treatment. 
 
7.1.6 SCREENING PROCEDURES 
Potential volunteers will be enrolled based on the presence of mild to 
moderate acne and their ability to meet the inclusion/exclusion criteria 
required for study enrollment. 
 

 
 
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7.2 
STUDY CONDUCT PROCEDURES 
7.2.1 BASELINE 
Male and female subjects will be enrolled in this single-site monadic study to 
evaluate the effect of a direct current device on acne treatment.  Subjects who 
sign the informed consent form and meet all inclusion criteria and none of the 
exclusion criteria will be enrolled at the baseline visit.  Subjects will be asked 
to continue their self-selected moisturizer, nonmedicated cleanser, and 
sunscreen they have used without difficulty for the prior 30 days and for the 
12 week study.  Subjects must also continue all facial products and cosmetics 
unchanged for the duration of the study.  No other oral or topical acne 
products can be used.  Subjects must be washed out of all topical acne 
products for at least 2 weeks and all oral acne products for at least 4 weeks.  
Subjects must possess mild to moderate acne with 5-30 inflammatory lesions 
and no nodules/cysts. 
 
At baseline visit, the dermatologist investigator will assess the face for the 
investigator global acne assessment (IGA) based on the following 5 point 
ordinal scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.  In 
addition, the dermatologist investigator will perform an inflammatory and 
noninflammatory lesion count within each facial quadrant (zone).  The 
subjects will then be provided the study device and electroconductive media 
for every other day use after cleansing to the acne afflicted facial zones.  The 
first use of the device will occur at the research center to ensure all subjects 
are using the device properly. 
 
The dermatologist investigator will assess the tolerability of the device in 
terms of peeling, dryness, redness, and swelling on a 5-point ordinal scale 
(0=none, 1=minimal, 2=mild, 3=moderate, and 4=severe).  The subjects will 
then assess device tolerability in terms of itching, burning, redness, and 
swelling.  All assessments will be made on a 5-point ordinal scale (0=none, 
1=minimal, 2=mild, 3=moderate, and 4=severe).  Subjects will be given their 
diaries and asked to return to the research center in 2 weeks.  A reminder text 
will be sent to encourage compliance prior to the week 2 visit. 
 
All investigator selected subjects will be photographed with the Canfield 
VISIA CR using Standard 1 lighting at baseline, week 2, week 4, and week 8, 
and week 12. 
 
7.2.2 WEEK 2 
At the week 2 visit, the dermatologist investigator will assess the face for the 
investigator global acne assessment (IGA) based on the following 5 point 
ordinal scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.  In 
addition, the dermatologist investigator will perform an inflammatory and 
noninflammatory lesion count within each facial quadrant.  The study device 

 
 
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will be inspected for proper operation and the study diary will be inspected for 
compliance. 
 
The dermatologist investigator will assess the tolerability of the device in 
terms of peeling, dryness, redness, and swelling on a 5-point ordinal scale 
(0=none, 1=minimal, 2=mild, 3=moderate, and 4=severe).  The subjects will 
then assess device tolerability in terms of itching, burning, redness, and 
swelling.  All assessments will be made on a 5-point ordinal scale (0=none, 
1=minimal, 2=mild, 3=moderate, and 4=severe).  The subjects will also 
complete a sponsor provided marketing questionnaire.  Subjects will be asked 
to return to the research center at week 4.  A reminder text will be sent to 
encourage compliance prior to the week 4 visit. 
 
All investigator selected subjects will be photographed with the Canfield 
VISIA CR using Standard 1 lighting at baseline, week 2, week 4, and week 8, 
and week 12. 
 
7.2.3 WEEK 4 
At the week 4 visit, the dermatologist investigator will assess the face for the 
investigator global acne assessment (IGA) based on the following 5 point 
ordinal scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.  In 
addition, the dermatologist investigator will perform an inflammatory and 
noninflammatory lesion count within each facial quadrant.  The study device 
will be inspected for proper operation and the study diary will be inspected for 
compliance. 
 
The dermatologist investigator will assess the tolerability of the device in 
terms of peeling, dryness, redness, and swelling on a 5-point ordinal scale 
(0=none, 1=minimal, 2=mild, 3=moderate, and 4=severe).  The subjects will 
then assess device tolerability in terms of itching, burning, redness, and 
swelling.  All assessments will be made on a 5-point ordinal scale (0=none, 
1=minimal, 2=mild, 3=moderate, and 4=severe).  The subjects will also 
complete a sponsor provided marketing questionnaire.  Subjects will be asked 
to return to the research center at week 8.  A reminder text will be sent to 
encourage compliance prior to the week 8 visit. 
 
All investigator selected subjects will be photographed with the Canfield 
VISIA CR using Standard 1 lighting at baseline, week 2, week 4, and week 8, 
and week 12. 
 
7.2.4 WEEK 8 
At the week 8 visit, the dermatologist investigator will assess the face for the 
investigator global acne assessment (IGA) based on the following 5 point 
ordinal scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.  In 
addition, the dermatologist investigator will perform an inflammatory and 

 
 
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noninflammatory lesion count within each facial quadrant.  The study device 
will be inspected for proper operation and the study diary will be inspected for 
compliance. 
 
The dermatologist investigator will assess the tolerability of the device in 
terms of peeling, dryness, redness, and swelling on a 5-point ordinal scale 
(0=none, 1=minimal, 2=mild, 3=moderate, and 4=severe).  The subjects will 
then assess device tolerability in terms of itching, burning, redness, and 
swelling.  All assessments will be made on a 5-point ordinal scale (0=none, 
1=minimal, 2=mild, 3=moderate, and 4=severe).  The subjects will also 
complete a sponsor provided marketing questionnaire.  Subjects will be asked 
to return to the research center at week 12.  A reminder text will be sent to 
encourage compliance prior to the week 12 visit. 
 
All investigator selected subjects will be photographed with the Canfield 
VISIA CR using Standard 1 lighting at baseline, week 2, week 4, and week 8, 
and week 12. 
 
7.2.5 WEEK 12 
At the week 12 visit, the dermatologist investigator will assess the face for the 
investigator global acne assessment (IGA) based on the following 5 point 
ordinal scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe.  In 
addition, the dermatologist investigator will perform an inflammatory and 
noninflammatory lesion count within each facial quadrant.  The study device 
will be inspected for proper operation and the study diary will be inspected for 
compliance.  The diary and the study materials will be collected. 
 
The dermatologist investigator will assess the tolerability of the device in 
terms of peeling, dryness, redness, and swelling on a 5-point ordinal scale 
(0=none, 1=minimal, 2=mild, 3=moderate, and 4=severe).  The subjects will 
then assess device tolerability in terms of itching, burning, redness, and 
swelling.  All assessments will be made on a 5-point ordinal scale (0=none, 
1=minimal, 2=mild, 3=moderate, and 4=severe).  The subjects will also 
complete a sponsor provided marketing questionnaire.  Subjects will complete 
their study participation at this time. 
 
All investigator selected subjects will be photographed with the Canfield 
VISIA CR using Standard 1 lighting at baseline, week 2, week 4, and week 8, 
and week 12. 
 
8. 
EFFICACY MEASURES 
8.1 
SUBJECT COMPLIANCE 
Compliance will be determined from the diary sheets.  Subjects will record 
device and electroconductive media application and any comments on the 

 
 
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provided weekly diary.  Diary sheets will remain at the study center as part of the 
source documentation records. 
 
9. 
FINAL SUBJECT STATUS 
A study termination form will be completed for each study subject who receives 
study product.  This includes subjects who completed the study or who withdrew 
or were withdrawn from study.  
 
9.1 
COMPLETED, DISCONTINUED OR 
INCOMPLETE SUBJECTS 
A completed subject is a subject who has satisfied all study entry criteria and 
completed the 12-week study.  For any subject who has started study and 
terminated from the study prematurely, every effort will be made to obtain final 
evaluations of clinical status.  Reasonable effort will be made to contact any 
subject lost to follow-up during the course of the study in order to complete 
assessments and retrieve any outstanding data and clinical supplies.  The 
investigator will choose the description that best describes the status of the 
subject at termination. 
 
1. Subject completed the 12 week study period 
 
OR INCOMPLETE/DISCONTINUED DUE TO: 
 
2. Contact dermatitis 
3. Adverse experience 
4. Serious adverse experience 
5. Pregnancy 
6. Protocol violation 
7. Subject withdrew consent 
8. Subject lost due to follow-up issues (e.g., attendance issues) 
9. Other (provide reason) 
 
10. 
STUDY PRODUCTS & 
ADMINISTRATION 
10.1 
FORMULATIONS 
The study will consist of the ZIIP device programmed for the treatment of 
acne and the electroconductive media 
 
10.2 
PRECAUTIONS 
Study products should be used as instructed and not orally consumed or 
placed in the eyes or around the orbital area of the eye.  The device should be 
used as described below: 
 

 
 
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1. Begin with clean, dry skin. 
2. Apply the conductive medium provided to you liberally over any areas 
where you have acne. 
3. Turn on your device by pressing the button at the top. You will hear one 
beep. 
4. Place the device on top of your skin. Lights will illuminate under the device 
when both silver probes come in contact with your skin. Both probes must 
keep contact with skin throughout treatment. 
5. Follow along with the video, slowly making circles with the top probe (the 
one farthest away from the charging port) over acne within each zone. (You 
may feel a tingling sensation during treatment. That is normal.) 
6. Do not treat a single spot more than one minute at a time. Only treat the 
facial zones identified for treatment.  
7. At the end of treatment, your device will beep twice and turn off. 
8. After treatment, wipe your device clean with a tissue, being careful to avoid 
the charging port. Spray the device and a second tissue lightly with rubbing 
alcohol and wipe again, remaining careful to avoid the charging port. 
9. Store safely away from water, moisture or debris. 
 
CHARGING: 
When you see the orange light flashing while using your device, it’s time to 
charge. 
To charge, plug in the charging cable provided. The orange light will remain 
illuminated while charging. You will know that your device is completely 
charged when the orange light is no longer on. 
 
CONTRAINDICATIONS 
ZIIP should not be used in the following areas 
- Breast area 
- Directly on top of the eyelid 
- Midline of neck (bone of neck) 
- Groin area 
- Do not use this device on patients who have a cardiac pacemaker, implanted 
defibrillator, or other implanted metallic or electronic device because this may 
cause electric shock 
 
WARNINGS 
Do not submerge the device in water or any other liquid(s). If you store your 
ZIIP in an area such as a bathroom counter, ensure the product does not come 
in contact with water or other liquid(s). 
 
ZIIP should not be used by: 
• Children 
• Pregnant Women 
• People subject to seizures 
• People with cancer/tumors 

 
 
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• People with a cardiac pacemaker 
• People with implanted defibrillators/stimulators 
• People with electronic implanted devices 
 
If you have any medical concerns, such as a severe medical illness, epilepsy 
or seizures, or recent facial surgery, please consult your doctor before using 
ZIIP. 
 
Electronic monitoring equipment (such as ECG monitors and ECG alarms) 
may not operate properly when a ZIIP device is in use. 
 
Stimulation should not be applied over, or in proximity to cancerous lesions, 
or applied over swollen, infected, or inflamed areas or skin eruptions, e.g., 
phlebitis, thrombophlebitis, broken capillaries, varicose veins, etc. Men 
should shave before use as hair can interfere with the conductivity of the 
electrodes. Facial area under a beard or mustache cannot be treated. 
 
Do not apply stimulation across your chest as the introduction of electrical 
current into the chest may cause rhythm disturbances to your heart, which 
could be lethal. 
 
The long-term effects of stimulation are not known. 
 
 
10.3 
STUDY PRODUCT ADMINISTRATION 
Subjects will use the acne device for applied 3 days per week on non-consecutive 
days, on all facial zones afflicted by acne.  The electroconductive media will be 
applied to the face prior to the use of the device.  The following instructions will 
be provided: 
1. Both silver probes must come in contact with skin throughout treatment. 
2. Slowly make continuous circles with the top probe (the one farthest away from 
the charging port) over acne within each facial zone. 
**NOTE: Instructional video will be provided for participants to follow** 
3. Treat each facial zone for 1 minute.  Your device will beep and vibrate at the 
one minute mark to indicate that treatment of that zone is complete.  Only treat 
the acne zone(s) identified for treatment. 
4. After treatment, wipe your device clean with a tissue, being careful to avoid the 
charging port. Spray the device and a second tissue lightly with rubbing alcohol 
and wipe again, remaining careful to avoid the charging port. 
5. Store safely away from water, moisture or debris. 
 
 
 
10.4 
PACKAGING, LABELING, DISTRIBUTION 
Study products will be dispensed in the packaging provided by the sponsor. 

 
 
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10.5 
 STORAGE AND ACCOUNTABILITY OF STUDY PRODUCT 
The study product will be stored at room temperature, away from sunlight, in a 
locked, limited access area at the study site.  Access to the study product will be 
limited to the investigator and staff members designated to dispense study 
medication.  A study product log will be used to record the dispensation and 
return of all study products.  The subject number/initials, and the initials and date 
of the person dispensing and receiving the returned study product will be 
documented on this form.  
 
10.6 
CODE DISCLOSURE 
The study coordinator will not develop a code as all subjects will use the active 
device and electroconductive media in this monadic study. 
 
11. 
 ADVERSE EVENTS 
11.1 
ADVERSE REACTIONS PREVIOUSLY 
REPORTED 
The study product has been reported to rarely produce skin irritation. 
 
11.2 
ADVERSE EXPERIENCES 
An adverse experience is defined as any untoward medical occurrence (sign, 
symptom or laboratory finding), regardless of severity and whether or not 
attributed to the study product. 
 
The investigator/coordinator will report all adverse experiences (AEs) that occur 
throughout the study.  All AEs will be recorded in the appropriate AE log.  The 
report will include: date of onset, a description of the AE, severity, seriousness, 
action taken, relationship to the study drug, outcome of the event, and date of 
resolution. 
 
11.2.1 ASSESSMENT OF SEVERITY 
The intensity or severity of an AE is characterized as: 
Mild: 
AE which is easily tolerated. 
Moderate: AE sufficiently discomforting to interfere with daily activity. 
Severe: 
AE which prevents normal daily activities. 
 
Subjects who are withdrawn from the study due to any AE will be followed by 
the investigator until the outcome is determined.  The investigator will 
summarize and document all information relating to the AE and follow up. 
 
11.2.2 RELATIONSHIP TO STUDY PRODUCT 
The relationship is characterized as: 

 
 
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Not Related - applies to any adverse experience that is clearly not related to 
use of the study product. 
Possible - means the association of the adverse experience with the study 
product is unknown; however, a relationship between study product and 
experience cannot be ruled out.   
Probable - there is a reasonable temporal relationship between the use of the 
study product and the adverse experience.  Based upon the investigator’s 
clinical experience, the association of the event with the study product seems 
likely. 
Definite - The AE occurs following the application of the study product and it 
cannot be reasonably explained by any other known characteristics of the 
subject’s clinical state, environmental or toxic factors, or other modes of 
therapy administered to the subject.  It disappears or decreases upon 
discontinuation of the study product and reappears on a re-challenge of the 
study product. 
 
11.3 
SERIOUS ADVERSE EVENTS 
Definition:  An SAE is defined as any adverse experience occurring that results 
in any of the following outcomes:   
 
1. death  
2. immediately life-threatening illness 
3. hospitalization ( > 24 hours) or prolongation of existing hospitalization 
4. a persistent or significant disability 
5. a congenital anomaly/birth defect 
6. “other” important medical event  
 
These are not anticipated, however, should an SAE occur, the primary 
investigator (Zoe Diana Draelos, MD) will immediately notify the sponsor.  The 
sponsor will provide instructions as to how to report the SAE to the FDA. 
 
12. 
STATISTICAL METHODS  
The statistical evaluation will be performed by Dermatology Consulting Services.  Along 
with descriptive statistics (means, standard deviations and percentages), investigator and 
subject ordinal nonparametric data will be analyzed using the Wilcoxon signed rank test.  
Acne lesion counts will be assessed using a Student t test.  Change will be considered 
significant at a p value of less than or equal to 0.05. 
 
 
12.1 
SAMPLE SIZE RATIONALE 
A sample size of 50 study subjects was chosen by the study sponsor. 
 

 
 
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12.2 
SIGNIFICANCE LEVEL 
Significance is defined at the p<0.05 level based on a two-sided test. 
 
12.3 
TOLERABILITY ASSESSMENT 
Subjects who discontinue will be queried as to any side effects experienced by 
the study products. The tolerability endpoint is the investigator-assessed absence 
of skin irritation from the facial study device at any time during the 12-week 
study. 
 
12.4 
SAFETY ASSESSMENT 
Incidence of all adverse events reported during the study will be summarized.  
Tabulated summaries will include adverse events grouped by relation to study 
product.  The safety endpoint is the absence of significant adverse reactions. 
 
12.5 
EFFICACY ASSESSMENT 
 
The efficacy endpoint is the investigator assessed improvement in investigator 
global assessment (IGA) after 12 weeks of every other day device use as 
compared to baseline. 
 
 
13. 
ETHICS 
13.1 
INFORMED CONSENT 
The principles of Informed Consent, according to FDA Regulations and ICH step 
5 guidelines on GCPs, will be followed.  
 
Subjects must provide written informed consent prior to any study procedures 
being completed.  Each subject’s signed informed consent must be kept on file 
by the Investigator for Regulatory Authorities’ inspection at any time.  A copy of 
the signed and dated consent form will be given to the subject. 
 
13.2 
INSTITUTIONAL REVIEW BOARD (IRB) 
The study will be submitted to an IRB selected by Dermatology Consulting 
Services for approval to insure the safety of the human subjects enrolled in the 
study. 
 
13.3 
SUBJECT CONFIDENTIALITY 
All participants are concerned for the individual subject’s privacy and, therefore, 
only a subject identification number and subject initials will identify all subject 
data.  However, in compliance with federal guidelines regarding the monitoring 
of clinical studies and in fulfillment of his/her obligations to the Sponsor, it is 
required that the Investigator permit the study monitor and/or FDA representative 

 
 
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to review that portion of the subject’s medical record that is directly related to the 
study.  This shall include all study relevant documentation including subject 
medical histories to verify eligibility, laboratory test result reports to verify 
transcription accuracy, admission/discharge summaries for hospital stays 
occurring while the subject is enrolled in the study, and autopsy reports for 
deaths occurring during the study. 
 
As part of the required content of informed consent, the subject must be informed 
that his/her medical chart may be reviewed by the sponsor, the Sponsor’s 
authorized representative, or a representative of the FDA.  Should access to the 
medical record require a separate waiver or authorization, it is the investigator’s 
responsibility to obtain such permission from the subject in writing before the 
subject is entered into the study.  All subjects will sign a HIPAA document as part 
of the informed consent. 
 
14. 
DOCUMENTATION 
14.1 
SITE DOCUMENTS REQUIRED FOR 
INITIATION 
Prior to the initiation of the study, the following items must be received: 
a) Sponsor approval of study 
b) Current curriculum vitae of the Investigators 
c) Copy of Principal Investigator’s Medical license 
d) A signed copy of the protocol Investigator’s Agreement page 
e) Original Non-Disclosure Agreement 
f) Signed Budget Agreement 
g) Approved FDA Investigational Device Exemption 
 
14.2 
STUDY DOCUMENTS SUPPLIED BY THE 
SPONSOR 
Dermatology Consulting Services will provide all study documents. 
 
14.3 
MAINTENANCE AND RETENTION OF 
RECORDS 
The study will be conducted according to Good Clinical Practices as outlined in 
ICH step 5 guidelines by the Food and Drug Administration.  It is the 
responsibility of the Investigator to maintain a comprehensive and centralized 
filing system of all relevant documentation. 
 
Investigators will be instructed to retain all study records required by the sponsor, 
as well as the regulations, in a secure and safe facility with limited access. 
Regulations require retention for a period of at least two years after last 
marketing approval and notification from the sponsor.  These regulatory 
documents should be retained for a longer period if required by local regulatory 
requirements. 

 
 
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Archiving of data - Copies of all pertinent records will be retained by the 
investigator for at least two years following final approval of the drug and/or 
notification from the sponsor.  These records include documents pertaining to the 
receipt and return of drug supplies, IRB, Informed Consent, as well as final 
signed case report forms.  No documents shall be transferred from the site or 
destroyed without first notifying the sponsor. The sponsor will archive the data 
for the lifetime of the product. 
 
 
14.3.1 CASE REPORT FORMS (CRF) 
CRFs for individual subjects will be provided and completed by Dermatology 
Consulting Services, as appropriate.  CRFs must be legible and complete.  
 
A CRF must be completed and signed by the investigator for each subject 
enrolled, including those removed from the study for any reason.  The reason 
for removal must be noted on the study conclusion CRF by the investigator 
for each subject.  CRFs must be kept current to reflect the subject’s status at 
each phase during the course of the study.  Subjects are not to be identified on 
CRFs by name; appropriately coded identification and the subject’s initials 
must be used.  The investigator must keep a separate log of the subject’s 
names and addresses. 
 
The research site will maintain the following documents: 
1. Subject Screening Log: This log will reflect the reason any subject 
screened for the study was found to be ineligible. 
2. Study Personnel Signature Log: This log will contain all site personnel 
along with their responsibilities and signatures. This log will be 
maintained at the site throughout the study. 
3. Monitoring Log: This log will contain the date and purpose of all 
monitoring visits by the Sponsor. 
4. Enrollment Log: This log will contain subject initials and start and end 
dates for all subjects enrolled. 
5. Product Inventory / Packing Slip Log: This log will reflect the total 
amount of study product shipped to the site and received and signed for by 
the Investigator. 
6. Product Accountability Log: This log will reflect the total amount of study 
product dispensed to and returned by each subject. 
 
14.3.2 
MONITORING 
A Sponsor appointed representative, if desired will monitor the study. 
 

 
 
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14.4 
PRIMARY SOURCE DOCUMENTS 
Dermatology Consulting Services will not maintain source documents for this 
study.  Final case report forms (CRFs) will be maintained as study 
documentation. 
 
14.5 
PROTOCOL MODIFICATION 
The procedures defined in the protocol and in the CRF will be carefully reviewed 
to ensure that all parties involved with the study fully understand the protocol.  In 
order to ensure the validity of the data, no deviations from the protocol may be 
made unless the issue is broad enough to warrant revision of the protocol.  Such 
revisions must be submitted to and have approval in writing from the Sponsor 
and the IRB prior to implementation. 
 
14.6 
AUDITS/INSPECTIONS 
During the course of the study and/or after it has been completed, one or more 
site visits may be undertaken by auditors as authorized representatives of the 
Sponsor.  
 
15. 
USE OF INFORMATION AND 
PUBLICATION 
15.1 
CONFIDENTIAL INFORMATION 
All information supplied by the Sponsor in connection with this study and not 
previously published, is considered confidential information.  This information 
includes, but is not limited to, the clinical protocol, case report forms, and other 
scientific data.  Any data collected during the study is considered confidential.  
This confidential information shall remain the sole property of the Sponsor, shall 
not be disclosed to others without written consent of the Sponsor, and shall not 
be used except in the performance of the study.   
 
The information developed during the conduct of this clinical study is also 
considered confidential, and will be used by the Sponsor in connection with the 
development of the study product.  The information may be disclosed as deemed 
necessary by Sponsor.  To allow the use of the information derived from this 
clinical study, the investigator is obliged to provide the Sponsor with complete 
test results and all data developed in this study.  The information obtained during 
this study may be made available to other investigators who are conducting 
similar studies with express written consent/agreement from sponsor.   
 
Should the investigator wish to publish the results of this study, the investigator 
agrees to provide the Sponsor with a manuscript for review 60 (sixty) days prior 
to submission for publication.  The Sponsor retains the right to delete from the 
manuscript confidential information and to prevent publication or modify its 
timing. 
 

 
 
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In the event the Sponsor chooses to publish the data from this study a copy will 
be provided to the investigator at least 30 days prior to the expected date of 
submission to the intended publisher. 
 
 

 
 
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       INVESTIGATOR’S AGREEMENT 
I have carefully read the foregoing protocol and agree that it contains all the 
necessary information for conducting this study safely.  I will conduct this study in 
strict accordance with this protocol, Good Clinical Practices, and local regulatory 
guidelines, and will attempt to complete the study within the time designated.  I will 
provide copies of the protocol and all other information relating to pre-clinical and 
prior clinical experience submitted by the Sponsor to all personnel responsible to me 
who participate in the study.  I will discuss this information with them to assure that 
they are adequately informed regarding the study product and conduct of the study.  
I agree to keep records on all subject information (case report forms, shipment and 
drug return forms and all other information collected during the study) in 
accordance with FDA regulations. 
 
 
 
 
___________________________________ 
______________ 
Principal Investigator’s Signature 
Date