Clinical trial NCT06415292
Conditions: Acne Vulgaris
Sponsor: Sun Pharmaceutical Industries Limited
Start date: 2023-11-27; Completion date: 2023-12-16
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Acne medications are a common source of facial dryness resulting in skin barrier damage and poor patient compliance. Retinoids and benzoyl peroxide are some of the most frequently prescribed and effective acne medications, however, dryness is an unwanted side effect. A new acne medication, 1% clascoterone, has been placed in a novel vehicle for excellent drug delivery in combination with excellent barrier properties. The barrier properties of 1% clascoterone have never been demonstrated. This study is aimed at better understanding the positive barrier effects of 1% clascoterone.

Detailed description:

Arms: arm 1: Splitface design- Subjects applied Winlevi (clascoterone) cream 1%, twice daily to the randomized half face following cleansing, every morning and evening. arm 2: Splitface design-no study product was applied to the untreated side of the face
Interventions: intervention 1: Winlevi (clascoterone) 1% cream
Intervention descriptions: intervention 1: Splitface design- Subjects applied Winlevi (clascoterone) cream 1%, twice daily to the randomized half face following cleansing, every morning and evening.

Protocol documents:
Prot_SAP_000.pdf: 
Official title: A Clinical Study to Assess the Skin Barrier Impact of Winlevi 
Document: Study Protocol, including Statistical Analysis Plan (SAP) 
NCT number: NCT06415292 
Document date: 10-Sep-2023 


CONFIDENTIAL 
DCS-94-23 
Page 1 of 22 
Sun Pharma Protocol 
September 10, 2023 
A Clinical Study to Assess the Barrier Impact of Winlevi 
STUDY NUMBER 
INVESTIGATOR 
STUDY SITE 
SPONSOR 
INVESTIGATIONAL PRODUCTS 
SPONSOR PRIMARY CONTACT 
STUDY DESIGN 
VERSION NUMBER 
DCS-94-23 
Zoe Diana Draelos, MD 
De1matology Consulting Services, PLLC 
2444 North Main Street 
High Point, NC, 27262 
SunPhaima 
Winlevi 
Kizito Kyeremateng 
Split Face 
1 
This document is confidential and contains proprietary info1mation of Dennatology 
Consulting Services, PLLC. Neither this document nor any info1m ation contained herein 
can be reproduced or disclosed to others without written consent of De1matology 
Consulting Services, PLLC. 
De1matology Consulting Se1vices, PLLC 
Zoe Diana Draelos, MD 


CONFIDENTIAL 
 
DCS-94-23 
Page 2 of 22
Dermatology Consulting Services, PLLC 
 
Zoe Diana Draelos, MD 
PROTOCOL NUMBER: DCS-94-23 
STUDY TITLE: A Clinical Study to Assess the Skin Barrier Impact of Winlevi 
 
 
PROTOCOL DATE: September 10, 2023 
 
 
The signatures below indicate this document represents the final and accepted 
protocol. 
 
 
 
 


CONFIDENTIAL 
 
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Dermatology Consulting Services, PLLC 
 
Zoe Diana Draelos, MD 
STUDY NUMBER ............................................................................................................ 1
1. 
PROTOCOL SYNOPSIS .......................................................................................... 5
2. 
STUDY VISIT SCHEDULE..................................................................................... 8
3. 
INTRODUCTION ..................................................................................................... 9
4. 
STUDY OBJECTIVE ............................................................................................... 9
5. 
STUDY DESIGN OVERVIEW ................................................................................ 9
6. 
STUDY POPULATION ............................................................................................ 9
6.1 
POPULATION DESCRIPTION ................................................................................................................ 9
6.2 
POPULATION SIZE ............................................................................................................................. 9
6.3 
INCLUSION CRITERIA....................................................................................................................... 10
6.4 
EXCLUSION CRITERIA ...................................................................................................................... 10
6.5 
CONCOMITANT MEDICATIONS ......................................................................................................... 11
7. 
CONDUCT OF STUDY: METHODS AND PROCEDURES ............................. 11
7.1 
ENROLLMENT.................................................................................................................................. 11
7.1.1
Informed Consent ................................................................................................................. 11
7.1.2
Dermatological Examination ................................................................................................ 11
7.1.3
Study Procedures .................................................................................................................. 11
7.1.4
Study Material Administration.............................................................................................. 11
7.1.5
Screening Procedures ........................................................................................................... 12
7.2 
STUDY CONDUCT PROCEDURES...................................................................................................... 12
7.2.1
Baseline ................................................................................................................................ 12
7.2.2
24 Hours ............................................................................................................................... 12
7.2.3
Week 1 .................................................................................................................................. 12
7.2.4
Week 2 .................................................................................................................................. 13
8. 
EFFICACY MEASURES ....................................................................................... 13
8.1 
STUDY MEASURES .......................................................................................................................... 13
8.2 
SUBJECT COMPLIANCE ..................................................................................................................... 13
8.3 
NONCOMPLIANT SUBJECTS .............................................................................................................. 13
9.
FINAL SUBJECT STATUS ................................................................................... 14
9.1 
COMPLETED, DISCONTINUED OR INCOMPLETE SUBJECTS ................................................................. 14
10. 
STUDY PRODUCTS & ADMINISTRATION ................................................ 14
10.1 
FORMULATIONS .......................................................................................................................... 14
10.2 
PRECAUTIONS ............................................................................................................................. 14
10.3 
STUDY PRODUCT ADMINISTRATION ........................................................................................... 14
10.4 
PACKAGING, LABELING, DISTRIBUTION..................................................................................... 15
10.5 
STORAGE AND ACCOUNTABILITY OF STUDY PRODUCT............................................................... 15
10.6 
CODE DISCLOSURE ...................................................................................................................... 15
11. 
ADVERSE EVENTS .......................................................................................... 15
11.1 
ADVERSE REACTIONS PREVIOUSLY REPORTED ........................................................................... 15
11.2 
ADVERSE EXPERIENCES .............................................................................................................. 15
11.2.1 
Assessment of Severity .......................................................................................................... 15
11.2.2 
Relationship to Study Product .............................................................................................. 16


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Dermatology Consulting Services, PLLC 
 
Zoe Diana Draelos, MD 
11.3 
SERIOUS ADVERSE EVENTS ......................................................................................................... 16
12. 
STATISTICAL METHODS .............................................................................. 16
12.1 
SAMPLE SIZE RATIONALE ............................................................................................................ 17
12.2 
SIGNIFICANCE LEVEL .................................................................................................................. 17
12.3 
DROP-OUT (PRODUCT TOLERABILITY) ASSESSMENT ................................................................... 17
12.4 
SAFETY ASSESSMENT .................................................................................................................. 17
12.5
ENDPOINTS ................................................................................................................................. 17
12.5.1 
Primary Efficacy Endpoint ................................................................................................... 17
12.5.2 
Secondary Efficacy Endpoint ................................................................................................ 17
13. 
ETHICS ............................................................................................................... 17
13.1 
INFORMED CONSENT ................................................................................................................... 17
13.2
INSTITUTIONAL REVIEW BOARD (IRB)........................................................................................ 17
13.3 
SUBJECT CONFIDENTIALITY ....................................................................................................... 18
14. 
DOCUMENTATION .......................................................................................... 18
14.1 
SITE DOCUMENTS REQUIRED FOR INITIATION .............................................................................. 18
14.2 
STUDY DOCUMENTS SUPPLIED BY THE SPONSOR ........................................................................ 18
14.3 
MAINTENANCE AND RETENTION OF RECORDS ............................................................................ 18
14.3.1 
Case report forms (CRF) ...................................................................................................... 19
14.3.2 
Monitoring ............................................................................................................................ 19
14.4 
PROTOCOL MODIFICATION .......................................................................................................... 20
14.5 
AUDITS/INSPECTIONS ................................................................................................................. 20
15. 
USE OF INFORMATION AND PUBLICATION........................................... 20
15.1 
CONFIDENTIAL INFORMATION .................................................................................................... 20
INVESTIGATOR’S AGREEMENT ............................................................................. 21
APPENDIX I: CASE REPORT FORMS ..................................................................... 22
 


CONFIDENTIAL 
DCS-94-23 
Page 5 of 22 
1. PROTOCOL SYNOPSIS 
Title of Study: 
A Clinical Study to Assess the Skin BaITier Impact ofWinlevi 
Study Period: 
2 weeks 
Test Products: 
Winlevi 
Apply twice daily to entire randomized side of face (product applied to 
randomized forehead, cheek, and jawline). 
Objective: 
The objective of this study is to demonstrnte the lack of baiTier damage 
induced by Winlevi as measured by comeometiy and TEWL. 
Design: 
Female or male subjects with acne prone skin will be enrolled in this split face 
single site study evaluating the baiTier effects of Winlevi. Subjects who sign 
consent and meet all inclusion criteria and none of the exclusion criteria will 
Study 
Population: 
Number of 
Subiects: 
Inclusion 
Criteria: 
be enrolled at the baseline visit. Subjects will be asked to continue their own, 
self-selected cleanser and sunscreen throughout the 2-week study with equal 
application to both sides of the face. The sunscreen and cleanser must have 
been used for 30 days prior to study enrollment without difficulty. Subjects 
must apply Winlevi twice daily to the randomized right or left face. 
Subjects will receive a compliance diaiy and the blinded study ti·eatment 
product to be applied to the randomized half face following cleansing, eve1y 
morning and evening. The assessing de1matologist investigator will be 
blinded as to which side of the face is receiving the Winlevi ti·eatment. 
Subjects will be seen at baseline, 24 hours, week 1, and week 2. The 
de1matologist investigator and subjects will assess tolerability for each side of 
the face sepai·ately at each visit on a 5 point ordinal scale. Noninvasive TEWL 
and comeometiy assessments of both sides of the face will be conducted at 
baseline, 24 hours, week 1, and week 2. 
Subjects will complete their study paiiicipation at week 2. The compliance 
dia1y and all study products will be collected at this time. Women of child 
bearing potential will be adininistered a urine pregnancy test at baseline and 
week 2. 
(There is an allowance.for an unscheduled visit at any time, if necessary.) 
Healthy female or male subjects 18+ years of age of all Fitzpatrick skin types 
who self identify as having sensitive acne prone skin. 
50 subjects 
1. Subjects who self identify as having sensitive acne prone skin. 
2. Female or male subjects 18+ yeai·s of age. 
3. Subiects with Fitzoati·ick skin tvoes I-VI. 
De1matology Consulting Se1vices, PLLC 
Zoe Diana Draelos, MD 


CONFIDENTIAL 
Exclusion 
Criteria: 
4. 
5. 
6. 
7. 
8. 
9. 
1. 
2. 
3. 
4. 
5. 
6. 
7. 
8. 
9. 
DCS-94-23 
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Subject agrees not to introduce any new colored cosmetics (lipsticks, 
eye shadows, facial foundations, blush, powder) or skin care products 
dming the study. 
Subjects must be willing to use only a cleanser and sunscreen on the 
entire face and no other skin care products. 
Subjects must be willing to use the Winlevi study product to designated 
half face. No other topical acne ti·eatment products on the entire face 
for the 2 week dmation of the study. 
Subject has signed an Informed Consent Fo1m in compliance with 
21CFR Pait 50: "Protection of Human Subjects." 
Subject is dependable and able to follow directions and is willing to 
comply with the schedule of visits. 
Subiect is in generally good physical and mental health. 
Any de1matological disorder, which in the investigator's opinion, may 
interfere with the accurate evaluation of the subject's skin 
characteristics, except for the conditions associated with sensitive skin. 
Subjects who ai·e not willing to use only the assigned study product and 
nothing else one randomized half face, except for cleanser and 
sunscreen that must remain unchanged during the study. Moisturizers 
or topical acne ti·eatment products should not be used during the 2 
week study period on either side of the face. 
Subjects who do not agree to refrain from direct sun exposure during 
the study duration. 
Subjects who have demonsti·ated a previous hypersensitivity reaction to 
any of the ingredients of the study products. 
Subjects, who ai·e pregnant, breast feeding, or planning a pregnancy. 
Subjects with clinically significant unstable medical disorders. 
Subjects who ai·e unwilling or unable to comply with the requirements 
of the protocol. 
Subjects who have histo1y of a psychological illness or condition that 
would interfere with their ability to understand and follow the 
requirements of the study. 
Subjects who ai·e cmTently paiiicipating in any other clinical study. 
10. Subjects with any planned surgeries and/or invasive medical 
procedures during the course of the study. 
11. Subjects who cmTently or frequently use high doses of anti-
inflammato1y drugs for a defined medication condition. Aspirin use 
should not exceed 2 tablets (650 mg) per day. 
12. Subjects cmTently receiving any anticancer, immunosuppressive 
u-eatinents/ medications (e.g., azathioprine, belimumab, 
cyclophosphainide, Enbrel, Imuran, Hmnira, mycophenolate mofetil, 
methoti·exate, prednisone, Reinicade, Stelara.), or radiation as 
dete1mined by the initial pape1work. 
13. Subjects with a histo1y of immunosuppression/immune deficiency 
disorders (including (HIV infection or AIDS) or currently using 
immunosuppressive medications ( e.g., azathioprine, belimumab, 
De1matology Consulting Se1vices, PLLC 
Zoe Diana Draelos, MD 


CONFIDENTIAL 
Endpoints: 
Measures: 
Statistical 
Methods: 
DCS-94-23 
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cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, 
methotrexate, prednisone, Remicade, Stelara) and/or radiation as 
detennined by study documentation. 
Primaiy Endpoint: 
The primaiy endpoint is the change in comeometiy reading between the two 
sides of the face ti·eated with Winlevi versus no ti·eatinent. 
Secondaiy Endpoints: 
The secondaiy endpoint is the change in TEWL reading between the two sides 
of the face ti·eated with Winlevi versus no ti·eatinent. 
De1matologist Investigator assessed tolerability pai·aineters: diyness, e1ythema, 
scaling, and irritation will be assessed separately for each side of the face. All 
assessments will be made on a 5-point ordinal scale (0=none, 1 =minimal, 
2=1nild, 3=moderate, 4=severe) at baseline, 24 hours, week 1, and week 2. 
Subject assessed tolerability pai·ameters: diyness, tightness, stinging, itching, 
and burning will be assessed separately for each side of the face. All 
assessments will be made on a 5-point ordinal scale (0=none, 1 =minimal, 
2=1nild, 3=moderate, 4=severe) at baseline, 24 hours, week 1, and week 2. 
Noninvasive Biomeasurements: TEWL and comeometi·y measurements on the 
right and left cheek will be conducted at baseline, 24 hours, week 1, and week 
2. 
Along with descriptive statistics (means, standai·d deviations and percentages), 
investigator ordinal nonparaineti·ic data will be analyzed using Wilcoxon 
signed rank test and sign test for paired comparison at different time points. 
The noninvasive pai·ameti·ic data will be analyzed using paired t-test. Change 
will be considered significant at the alpha level of 0.05. 
De1matology Consulting Se1vices, PLLC 
Zoe Diana Draelos, MD 


CONFIDENTIAL 
2. STUDY VISIT SCHEDULE 
Visit 
1 
Procedures 
BL 
Informed Consent 
X 
Procedure 
Inclusion/Exclusion 
X 
Criteria 
Brief Medical History and 
Concomitant Medications 
X 
Review 
Investigator Clinical 
X 
Grading for Tolerability 
Subject Clinical Gradin2 
X 
for Tolerability 
Product Dispensing 
X 
TEWL (both facial sides) 
X 
Corneometry (both facial 
X 
sides) 
Urine Pre2nancy Test 
X 
(WOCP) 
Adverse Events 
Subject Diary Assessment 
and Compliance Check 
Subject Product 
Accountability and Study 
Completion 
De1matology Consulting Se1vices, PLLC 
Visit 
Visit 
2 
3 
24 
Week 
Hours 
1 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Visit 
4 
Week 
2 
X 
X 
X 
X 
X 
X 
X 
X 
X 
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Zoe Diana Draelos, MD 


CONFIDENTIAL 
 
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Dermatology Consulting Services, PLLC 
 
Zoe Diana Draelos, MD 
3.  INTRODUCTION 
Acne medications are a common source of facial dryness resulting in skin barrier damage 
and poor patient compliance.  Retinoids and benzoyl peroxide are some of the most 
frequently prescribed and effective acne medications, however, dryness is an unwanted 
side effect.  A new acne medication, 1% clascoterone, has been placed in a novel vehicle 
for excellent drug delivery in combination with excellent barrier properties.  The barrier 
properties of 1% clascoterone have never been demonstrated.  This study is aimed at 
better understanding the positive barrier effects of 1% clascoterone. 
4. STUDY OBJECTIVE 
The objective of this study is to demonstrate the lack of barrier damage induced by Winlevi as 
measured by corneometry and TEWL. 
 
5. STUDY DESIGN OVERVIEW
Female or male subjects with acne prone skin will be enrolled in this split face single site 
study evaluating the barrier effects of Winlevi.  Subjects who sign consent 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 own, self-selected cleanser and sunscreen 
throughout the 2-week study with equal application to both sides of the face.  The 
sunscreen and cleanser must have been used for 30 days prior to study enrollment without 
difficulty.  Subjects must apply Winlevi twice daily to the randomized right or left face. 
Subjects will receive a compliance diary and the blinded study treatment product to be 
applied to the randomized half face following cleansing, every morning and evening.  
The assessing dermatologist investigator will be blinded as to which side of the face is 
receiving the Winlevi treatment.  Subjects will be seen at baseline, 24 hours, week 1, and 
week 2.  The dermatologist investigator and subjects will assess tolerability for each side 
of the face separately at each visit on a 5 point ordinal scale.  Noninvasive TEWL and 
corneometry assessments of both sides of the face will be conducted at baseline, 24 
hours, week 1, and week 2. 
Subjects will complete their study participation at week 2.  The compliance diary and all 
study products will be collected at this time. Women of child bearing potential will be 
administered a urine pregnancy test at baseline and week 2. 
6. STUDY POPULATION 
6.1 POPULATION DESCRIPTION 
Healthy female or male subjects 18+ years of age of all Fitzpatrick skin types who self 
identify as having sensitive acne prone skin. 
 
6.2 POPULATION SIZE 
50 subjects 
 


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Zoe Diana Draelos, MD 
6.3 INCLUSION CRITERIA 
The following items represent the inclusion criteria: 
1. Subjects who self identify as having sensitive acne prone skin. 
2. Female or male subjects 18+ years of age. 
3. Subjects with Fitzpatrick skin types I-VI. 
4. Subject agrees not to introduce any new colored cosmetics (lipsticks, eye 
shadows, facial foundations, blush, powder) or skin care products during the 
study. 
5. Subjects must be willing to use only a cleanser and sunscreen on the entire face 
and no other skin care products. 
6. Subjects must be willing to use the Winlevi study product to designated half face.  
No other topical acne treatment products on the entire face for the 2 week 
duration of the study. 
7. Subject has signed an Informed Consent Form in compliance with 21CFR Part 50: 
"Protection of Human Subjects." 
8. Subject is dependable and able to follow directions and is willing to comply with 
the schedule of visits. 
9. Subject is 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 conditions associated with sensitive skin. 
2. Subjects who are not willing to use only the assigned study product and 
nothing else one randomized half face, except for cleanser and sunscreen that 
must remain unchanged during the study.  Moisturizers or topical acne 
treatment products should not be used during the 2 week study period on 
either side of the face. 
3. Subjects who do not agree to refrain from direct sun exposure during the study 
duration. 
4. Subjects who have demonstrated a previous hypersensitivity reaction to any of 
the ingredients of the study products. 
5. Subjects, who are pregnant, breast feeding, or planning a pregnancy. 
6. Subjects with clinically significant unstable medical disorders. 
7. Subjects who are unwilling or unable to comply with the requirements of the 
protocol.  
8. Subjects who have history of a psychological illness or condition that would 
interfere with their ability to understand and follow the requirements of the 
study. 
9. Subjects who are currently participating in any other clinical study.  
10. Subjects with any planned surgeries and/or invasive medical procedures 
during the course of the study. 


CONFIDENTIAL 
 
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Zoe Diana Draelos, MD 
11. Subjects who currently or frequently use high doses of anti-inflammatory 
drugs for a defined medication condition. Aspirin use should not exceed 2 
tablets (650 mg) per day.  
12. Subjects currently receiving any anticancer, immunosuppressive treatments/ 
medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, 
Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, 
Remicade, Stelara.), or radiation as determined by the initial paperwork.
13. Subjects with a history of immunosuppression/immune deficiency disorders 
(including (HIV infection or AIDS) or currently using immunosuppressive 
medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, 
Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, 
Remicade, Stelara) and/or radiation as determined by study documentation. 
 
6.5 CONCOMITANT MEDICATIONS
No topical medications are allowed on the face.  No facial skin care products 
other than sunscreen and cleanser are allowed on the face.  The subject must have 
used the self-selected sunscreen and cleanser for at least 30 days without 
difficulty.
7. CONDUCT OF STUDY: METHODS AND PROCEDURES 
7.1 ENROLLMENT  
7.1.1 INFORMED CONSENT 
A signed informed consent form must be obtained from each subject prior to 
performing any study procedures.  No study related procedures or activities 
will be performed until each subject is fully informed and the consent form is 
signed and dated. 
 
7.1.2 DERMATOLOGICAL EXAMINATION 
A skin examination will be performed to ensure all subject meet 
inclusion/exclusion criteria. 
 
7.1.3 STUDY PROCEDURES  
The subjects will be screened for the inclusion and exclusion criteria prior to 
study enrollment.  Only subjects who meet the requirements, have signed an 
informed consent, and have given a medical history will be entered into the 
study.  All other subjects will be considered screening failures. 
 
7.1.4 STUDY MATERIAL ADMINISTRATION  
The subjects will use 1% clascoterone as marketed (Winlevi) on one 
randomized side of the face. 


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Dermatology Consulting Services, PLLC 
 
Zoe Diana Draelos, MD 
7.1.5 SCREENING PROCEDURES 
Potential volunteers will be enrolled based on their ability to meet the 
inclusion/exclusion criteria required for study enrollment. 
 
7.2 STUDY CONDUCT PROCEDURES 
7.2.1 BASELINE 
Female or male subjects with acne prone skin will be enrolled in this split face 
single site study evaluating the barrier effects of Winlevi.  Subjects who sign 
consent 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 own, 
self-selected cleanser and sunscreen throughout the 2-week study with equal 
application to both sides of the face.  The sunscreen and cleanser must have 
been used for 30 days prior to study enrollment without difficulty.  Subjects 
must apply Winlevi twice daily to the randomized right or left face.  Women 
of child bearing potential will receive a urine pregnancy test. 
 
Subjects will receive a compliance diary and the blinded study treatment 
product to be applied to the randomized half face following cleansing, every 
morning and evening.  The assessing dermatologist investigator will be 
blinded as to which side of the face is receiving the Winlevi treatment.  The 
dermatologist investigator and subjects will assess tolerability for each side of 
the face separately at each visit on a 5 point ordinal scale (0=none, 
1=minimal, 2=mild, 3=moderate, 4=severe).  Noninvasive TEWL and 
corneometry assessments of both sides of the face will be conducted.  Subjects 
will be instructed to return to the research facility in 24 hours.  A reminder 
text for compliance will be sent prior to the return visit. 
 
7.2.2 24 HOURS 
Subjects will return to the research center in 24 hours.  The dermatologist 
investigator and subjects will assess tolerability for each side of the face 
separately at each visit on a 5 point ordinal scale (0=none, 1=minimal, 
2=mild, 3=moderate, 4=severe).  Noninvasive TEWL and corneometry 
assessments of both sides of the face will be conducted.  Subjects will be 
instructed to return to the research facility at week 1.  A reminder text for 
compliance will be sent prior to the return visit. 
7.2.3 WEEK 1
Subjects will return to the research center at week 1.  The dermatologist 
investigator and subjects will assess tolerability for each side of the face 
separately at each visit on a 5 point ordinal scale (0=none, 1=minimal, 
2=mild, 3=moderate, 4=severe).  Noninvasive TEWL and corneometry 
assessments of both sides of the face will be conducted. Subjects will be 


CONFIDENTIAL 
 
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Zoe Diana Draelos, MD 
instructed to return to the research facility at week 2.  A reminder text for 
compliance will be sent prior to the return visit. 
7.2.4 WEEK 2
Subjects will return to the research center at week 2.  The dermatologist 
investigator and subjects will assess tolerability for each side of the face 
separately at each visit on a 5 point ordinal scale (0=none, 1=minimal, 
2=mild, 3=moderate, 4=severe).  Noninvasive TEWL and corneometry 
assessments of both sides of the face will be conducted.  Women of child 
bearing potential will be administered a urine pregnancy test.  Subjects will 
complete their study participation at week 2.  The compliance diary and all 
study products will be collected at this time. 
8. EFFICACY MEASURES 
8.1 STUDY MEASURES 
Dermatologist Investigator assessed tolerability parameters: dryness, erythema, 
scaling, and irritation will be assessed separately for each side of the face. All 
assessments will be made on a 5-point ordinal scale (0=none, 1=minimal, 2=mild, 
3=moderate, 4=severe) at baseline, 24 hours, week 1, and week 2.  
Subject assessed tolerability parameters: dryness, tightness, stinging, itching, and 
burning will be assessed separately for each side of the face. All assessments will 
be made on a 5-point ordinal scale (0=none, 1=minimal, 2=mild, 3=moderate, 
4=severe) at baseline, 24 hours, week 1, and week 2. 
Noninvasive Biomeasurements: TEWL and corneometry measurements on the 
right and left cheek will be conducted at baseline, 24 hours, week 1, and week 2. 
8.2 SUBJECT COMPLIANCE
The diary sheets will be used to determine compliance.  Subjects will record 
product application and any comments on the provided weekly diary.  Diary 
sheets will remain at the study center as part of the source documentation 
records.
8.3 NONCOMPLIANT SUBJECTS 
Subjects who are found to be noncompliant will be queried as to the reason for 
their noncompliance.  If noncompliance results from study product problems, full 
interviews will be conducted by the investigator to determine the nature and 
severity of the problem and an adverse event will be recorded.  Subjects who are 
noncompliant will be released from their study participation and their last visit 
data carried forward.


CONFIDENTIAL 
 
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Zoe Diana Draelos, MD 
9. FINAL SUBJECT STATUS
Study termination forms 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 2-week study.  For any subject who has started study and 
terminates the study prematurely, efforts will be made to obtain final evaluations 
of clinical status.  Reasonable efforts 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 2-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 to follow-up 
9. Other 
 
10. STUDY PRODUCTS & ADMINISTRATION 
10.1 FORMULATIONS 
Subjects will apply Winlevi as currently marketed to one randomized side of the 
face twice daily 
10.2 PRECAUTIONS 
Study products should be used in their intended fashion and not orally consumed 
or placed in the eyes. 
 
10.3 STUDY PRODUCT ADMINISTRATION
The subjects will apply the study products twice daily to the randomized side of 
the face.  The study products will be labeled left and right to ensure subject 
compliance.  The subjects will receive the following instructions: 
Apply twice daily to entire randomized side of face (product applied to 
randomized forehead, cheek, and jawline). 
 


CONFIDENTIAL 
 
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Dermatology Consulting Services, PLLC 
 
Zoe Diana Draelos, MD 
10.4 PACKAGING, LABELING, DISTRIBUTION 
Study products will be dispensed in packaging as currently marketed provided by 
the sponsor. 
 
10.5  STORAGE AND ACCOUNTABILITY OF STUDY PRODUCT 
The study products will be stored at room temperature in a locked, limited access 
area at the study site.  Only the investigator and staff members designated to 
dispense study medication will be allowed access to the study products.  Study 
product logs 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 products will be documented on this 
form.  
 
10.6 CODE DISCLOSURE 
A randomization code will be maintained indicating which side of the face 
received the currently marketed Winlevi.  An independent blinded dispenser who 
is not associated with other study activities will randomize the study products 
and maintain the randomization until data lock occurs. 
11.  ADVERSE EVENTS
11.1 ADVERSE REACTIONS PREVIOUSLY REPORTED
The study products have 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. 


CONFIDENTIAL 
 
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Dermatology Consulting Services, PLLC 
 
Zoe Diana Draelos, MD 
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 will document all information relating to the AE and follow up. 
11.2.2 RELATIONSHIP TO STUDY PRODUCT 
The relationship is characterized as: 
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.  This is necessary to evaluate allergic or irritant contact 
dermatitis. 
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 accept responsibility to notify the 
sponsor. 
 
12. STATISTICAL METHODS  
Along with descriptive statistics (means, standard deviations and percentages), 
investigator and subject ordinal nonparametric results will be analyzed using 
Wilcoxon signed rank test and sign test for paired comparison at different time 
points.  The noninvasive parametric results will be analyzed using paired t-test. 
Changes will be considered significant at the alpha level of 0.05. 


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Dermatology Consulting Services, PLLC 
 
Zoe Diana Draelos, MD 
12.1 SAMPLE SIZE RATIONALE 
A sample size of 50 study subjects was chosen by the study sponsor. 
12.2 SIGNIFICANCE LEVEL 
Significance is defined at the p<0.05 level based on a two-sided test. 
 
12.3 DROP-OUT (PRODUCT TOLERABILITY) ASSESSMENT 
Subjects who discontinue will be queried as to any side effects experienced by 
the study products. 
 
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. 
 
12.5 ENDPOINTS 
12.5.1 PRIMARY EFFICACY ENDPOINT 
The primary endpoint is the change in corneometry reading between the side of the face 
treated with Winlevi versus no treatment. 
 
12.5.2 SECONDARY EFFICACY ENDPOINT 
The secondary endpoint is the change in TEWL reading between the side of the face 
treated with Winlevi versus no treatment. 
 
 
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.  Subject signed informed consents will be kept on file by the 
Investigator for Regulatory Authorities’ inspection at any time.  A copy of the 
signed and dated consent forms will be given to the subject. 
 
13.2 INSTITUTIONAL REVIEW BOARD (IRB) 
The study documents will be submitted to an IRB selected by Dermatology 
Consulting Services for approval to ensure the safety of the human subjects 
enrolled in the study.


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Zoe Diana Draelos, MD 
13.3 SUBJECT CONFIDENTIALITY 
All participants are concerned for the individual subject’s privacy and, therefore, 
all subject results will be identified only by a subject identification number.  
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 
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. 
 
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 Principal Investigator 
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 
 
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 activities 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 


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Zoe Diana Draelos, MD 
documents should be retained for a longer period if required by local regulatory 
requirements.
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.  
 
CRFs 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 CRFs 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 Logs: Logs will reflect the reason any subject screened 
for the study was found to be ineligible. 
2. Study Personnel Signature Logs: Logs will contain all site personnel along 
with their responsibilities and signatures. Logs will be maintained at the 
site throughout the study. 
3. Monitoring Logs: Logs will contain the date and purpose of all monitoring 
visits by the Sponsor. 
4. Enrollment Logs: Logs will contain subject initials and start and end dates 
for all subjects enrolled. 
5. Product Inventory / Packing Slip Logs: Logs will reflect the total amount 
of study product shipped to the site and received and signed for by the 
Investigator. 
6. Product Accountability Logs: Logs will reflect the total amount of study 
product dispensed to and returned by each subject. 
14.3.2 MONITORING 
The study activities will be monitored by a Sponsor appointed representative, 
if desired. 
 


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Zoe Diana Draelos, MD 
14.4 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.
14.5 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.   
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 
publication timing.
In the event the Sponsor chooses to publish the data from this study, copies 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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Dermatology Consulting Services, PLLC 
 
Zoe Diana Draelos, MD 
 
 
 
       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 


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Dermatology Consulting Services, PLLC 
 
Zoe Diana Draelos, MD 
APPENDIX I: CASE REPORT FORMS
The following documents are attached: 
 
1. Screening Questionnaire 
2. Inclusion/Exclusion Criteria 
3. Investigator Questionnaires Tolerability 
4. Subject Questionnaires Tolerability 
5. Adverse Event Assessment 
6. Study Termination 
7. Informed Consent Form (as a separate file) 
8. Subject Diary (as a separate file) 
 


Dermatology Consulting Services, PLLC 
 
Protocol Number: DCS-94-23 
 
Dermatology Consulting Services, PLLC 
 
Zoe Diana Draelos, MD 
SCREENING QUESTIONNAIRE 
 DATE_________________________ 
 
 
NAME____________________________________________________________________________________________ 
LAST
FIRST
MIDDLE INITIAL          
 
 
DATE OF BIRTH_________________                                       AGE_________________  
 
SOCIAL SECURITY_________-_________-__________ 
GENDER AT BIRTH____________________  
 
RACE_______________________________ 
 
STREET ADDRESS_____________________________________________________________________________ 
 
 
CITY________________________________________ STATE_____________________ ZIP____________________ 
 
 
 
E-MAIL_____________________________________________________________________________________________ 
 
 
CELL PHONE (            )______________-_____________   CELL PHONE CARRIER_______________ 
 
     
EMERGENCY CONTACT  
NAME____________________________________                       RELATIONSHIP________________ 
 
EMERGENCY CONTACT 
CELL PHONE (            )______________-_____________      
 
 
I understand federal law requires any person who receives more than $600 in a calendar year 
from our office must be issued a 1099 tax form.  I understand I must provide my social security 
number to participate in this study. 
  
 
 
SIGNATURE________________________________________________DATE___________________________ 


Dermatology Consulting Services, PLLC 
 
Protocol Number: DCS-94-23 
 
Dermatology Consulting Services, PLLC 
 
Zoe Diana Draelos, MD 
INCLUSION/EXCLUSION CRITERIA 
Inclusion Criteria: 
1. Subjects who self identify as having sensitive acne prone skin. 
2. Female or male subjects 18+ years of age. 
3. Subjects with Fitzpatrick skin types I-VI. 
4. Subject agrees not to introduce any new colored cosmetics (lipsticks, eye shadows, facial 
foundations, blush, powder) or skin care products during the study. 
5. Subjects must be willing to use only a cleanser and sunscreen on the entire face and no other skin 
care products. 
6. Subjects must be willing to use the Winlevi study product to designated half face.  No other 
topical acne treatment products on the entire face for the 2 week duration of the study. 
7. Subject has signed an Informed Consent Form in compliance with 21CFR Part 50: "Protection of 
Human Subjects." 
8. Subject is dependable and able to follow directions and is willing to comply with the schedule of 
visits. 
9. Subject is 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 conditions associated 
with sensitive skin. 
2. Subjects who are not willing to use only the assigned study product and nothing else one 
randomized half face, except for cleanser and sunscreen that must remain unchanged during 
the study.  Moisturizers or topical acne treatment products should not be used during the 2 
week study period on either side of the face. 
3. Subjects who do not agree to refrain from direct sun exposure during the study duration. 
4. Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients 
of the study products. 
5. Subjects, who are pregnant, breast feeding, or planning a pregnancy. 
6. Subjects with clinically significant unstable medical disorders. 
7. Subjects who are unwilling or unable to comply with the requirements of the protocol.  
8. Subjects who have history of a psychological illness or condition that would interfere with 
their ability to understand and follow the requirements of the study. 
9. Subjects who are currently participating in any other clinical study.  
10. Subjects with any planned surgeries and/or invasive medical procedures during the course of 
the study. 
11. Subjects who currently or frequently use high doses of anti-inflammatory drugs for a defined 
medication condition. Aspirin use should not exceed 2 tablets (650 mg) per day.  
12. Subjects currently receiving any anticancer, immunosuppressive treatments/ medications 
(e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate 
mofetil, methotrexate, prednisone, Remicade, Stelara.), or radiation as determined by the 
initial paperwork. 
13. Subjects with a history of immunosuppression/immune deficiency disorders (including (HIV 
infection or AIDS) or currently using immunosuppressive medications (e.g., azathioprine, 
belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, 
methotrexate, prednisone, Remicade, Stelara) and/or radiation as determined by study 
documentation. 
All inclusion criteria must be met and none of the exclusion criteria.  Circle any inclusion criteria that are 
not met and any exclusion criteria that are met and declare the subject a screening failure. 
I certify all inclusion criteria have been met and none of the exclusion criteria have been met. 
 
_____________________________ 
 
 
______________________ 
Zoe Diana Draelos, MD 
 
 
 
Date 
Primary Investigator 
 


Dermatology Consulting Services, PLLC 
 
Protocol Number: DCS-94-23 
 
Dermatology Consulting Services, PLLC 
 
Zoe Diana Draelos, MD 
INVESTIGATOR TOLERABILITY ASSESSMENT 
RIGHT CHEEK 
Visits 
Baseline 
24 Hours 
Week 1 
Week 2
Dryness 
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4 
Erythema 
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4 
Scaling
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4 
Irritation 
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4 
LEFT CHEEK 
Visits 
Baseline 
24 Hours 
Week 1 
Week 2
Dryness 
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4 
Erythema 
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4 
Scaling
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4 
Irritation 
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4 
0=none, 1=minimal, 2=mild, 3=moderate, 4=severe
 
 


Dermatology Consulting Services, PLLC 
 
Protocol Number: DCS-94-23 
 
Dermatology Consulting Services, PLLC 
 
Zoe Diana Draelos, MD 
SUBJECT TOLERABIILTY ASSESSMENT 
Please let us know if you are experiencing any of these problems.  Please use the 
following scale: 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe.  A lower number 
means you do not have the problem.  Circle your correct response.  Please rate both your 
cheeks separately. 
Ask the study staff if you have any questions.
RIGHT CHEEK 
Visits
Baseline
24 Hours
Week 1
Week 2
Dryness 
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4 
Tightness 
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4 
Stinging 
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4 
Itching
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4 
Burning
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4 
LEFT CHEEK 
Visits 
Baseline 
24 Hours 
Week 1 
Week 2
Dryness 
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4 
Tightness 
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4 
Stinging 
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4 
Itching
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4 
Burning
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4
0..1...2..3..4 


Dermatology Consulting Services, PLLC 
 
Protocol Number: DCS-94-23 
 
Dermatology Consulting Services, PLLC 
 
Zoe Diana Draelos, MD 
NONINVASIVE ASSESSMENTS 
Baseline 
 
24 Hours 
Week 1 
Week 2 
TEWL 
Right Cheek 
 
 
 
TEWL 
Left Cheek
 
 
 
Corneometry  
Right Cheek 
 
 
 
Corneometry 
Left Cheek
 
 
 


Dermatology Consulting Services, PLLC 
 
Protocol Number: DCS-94-23 
 
Dermatology Consulting Services, PLLC 
 
Zoe Diana Draelos, MD 
ADVERSE EVENT 
Did the subject experience any adverse event? Yes or No
*If yes, list below: 
Adverse Event 
1
2
Start Date 
mm/dd/yy 
Stop Date
mm/dd/yy 
Ongoing* 
Frequency1
Severity2
Relation to Study Med3
Action Taken4
Outcome5 
Serious
(Y/N) 
1Frequency 
2Severity        3Relation to Study Med    4Action Taken (insert all codes that apply)  
1=Continuous    1=Mild           1=Not related                    1=None                                               
2=Intermittent   2=Moderate    2=Possible
 
        2=Study drug discontinued 
3=Isolated         3=Severe         3=Probable
3=Non-drug therapy 
 
 
 
  4=Definite 
 
        4=New OTC or Rx  drug added 
 
 
 
 
 
 
 
 
5Outcome 
1=Resolved 
2=Improved 
3=Stabilized 
4=Ongoing 
5=Worsened 
6=Lost to follow-up 
*Check only if the adverse event is ongoing when subject completes/exits the study. 
  **Refer to the protocol for definitions of severity and relationship to study product.


Dermatology Consulting Services, PLLC 
Protocol Number: DCS-94-23 
Final Subject Status 
D The subject completed the study. 
Date Completed: I I I 
Month rnrn 
Day 
Year 
D The subject discontinued the study prematurely due to the following ~ 
reason: 
Date Discontinued. I I I rnrn 
Month 
Day 
Year 
D Adverse event, including intercmTent illness, which required study 
discontinuation (specify) ___________________ _ 
D Protocol violation (specify) _____________ _ 
D Lost to follow-up 
D Subject decision/withdrawal of consent 
D Other (specify) ________________ _ 
Investigator's Statement: 
I have reviewed all pages of this case report form. To the best of my knowledge, the 
information recorded on the case report form is a complete and accurate record of 
this subject's treatment course during the study. 
Signature 
Printed Name 
Date Signed: _I _I __ I rn OJ 
Month 
Day 
Year 
De1matology Consulting Se1vices, PLLC 
Zoe Diana Draelos, MD