The Efficacy and Safety of Winlevi in Skin of Color Patients With Acne
Phase: PHASE4
Conditions: Acne Vulgaris
Sponsor: Sun Pharmaceutical Industries Limited

Official title: The Efficacy and Safety of Winlevi in Skin of Color Patients With Acne. 
Document: Study Protocol 
NCT number: NCT06415305 
Document date: 07 Dec 2023 

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PROTOCOL SIGNATURE PAGE 
 
 
 
The signature below constitutes the approval of this protocol and the supplements, and provides the 
necessary assurances that this trial will be conducted according to all stipulations of the protocol, 
including all statements regarding confidentiality, and according to local legal and regulatory 
requirements and ICH-GCP guidelines. 
 
 
 
 
 
 
Investigator 
 
 
 
 
 
                                                                                                                                  
            
Printed Name   
 
 
 
 
Signature 
 
 
Date  
 

 
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1 
GENERAL INFORMATION 
1.1 
Introduction 
 
Acne vulgaris is the most common skin disease in patients with skin of color and second most 
common in Caucasian population1.  The global prevalence is thought to be as high as 60-80% in 
individuals 12-25 years of age1,2.  However, it is not limited to only teenagers but also to adults, 
especially adult females3.  The pathogenesis of acne is multifactorial.  Genetics may also play a role. 
 The treatment pathway should be directed to different pathogenic factors including, excessive 
sebum production, hyper keratinization, P. acnes, and inflammation4,5,6,7,8.   
Data is limited for skin of color patients in Phase III registration trials. Data is limited 
because there a few studies that focus on patients with skin of color.  Therefore, a 
unique study dedicated to patients with skin of color in a real-world setting will be 
welcome to add further evidence to phase III data. 
 
 
Winlevi is the first topical anti androgen and sebum inhibitor approved for acne vulgaris.9 However, 
we do not have any clinical experience with Winlevi in treatment for acne 
Therefore ,it  is reasonable to study Winlevi  to emulate real life practice. 
 
 
References: 
1. Ghodsi SZ, Orawa, H, Zouboulis, CC: Prevalence, severity, and severity of risk factors in 
acne in high school pupils; a community based study. J Invest Dermatol 2009;129:2136-
2141 
2. Plewig G, Kligman AM: Acne and rosacea, ed 3. Berlin Springer, 2000. 
3. Perkins AC, Maglione J, Hillebrand GG, Miyamoto K, Kimball AB: Acne vulgaris in 
women, prevalence across the life span. J Womens Health (Larchmt) 2012;21:223-230 
4. Williams C, Layton AM: Persistent acne in women: implications for the patient and for 
therapy. Am J Clin Dermatol 2006;7:218-290 
5. Jeremy AH, Holland DB, Roberts SG, Thompson KF, Cunliffe WJ: Inflammatory events 
are involved in acne lesion initiation. J invest Dermatol 2003;121:20-27 
6. Nagy I, Pivarcsi A, Koreck A, Szell M, Urban E, Kemeny L: Distinct strains of Propioni-
bacterium acnes induce selective human β-defensin-2 and interleukin-8 expression in 
human keratinocytes through toll-like receptors. J Invest Dermatol 2005;124:931-938 
7. Holland C, Mak TN, Zimny-Arndt U, Schmid M, Meyer TF, Jungblut PR, Bruggemann 
H: Proteomic indentification of secreted proteins of Propionibacterium acnes. BMC 
microbiol 2010;10:230 
8. Lomholt HB, Kilian M: Population genetic analysis of Propionibacterium acnes identifies 
a subpopulation and epidemic clones associated with acne. PloS One 2010;5:e12277 
9. Winlevi packge insert 
 
 
 
 

 
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4.2 
Exclusion Criteria 
i. 
Female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who 
are of childbearing potential and not practicing a reliable method of birth control.  
ii. 
Allergy or sensitivity to any component of the test medications (Section 5.2). 
iii. 
Subjects who have not complied with the proper wash-out periods for prohibited medications 
(Supplement I). 
iv. 
Medical condition that, in the opinion of the Investigator, contraindicates the subject’s 
participation in the clinical study. 
v. 
Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris  
vi. 
Evidence of recent alcohol or drug abuse. 
vii. 
History of poor cooperation, non-compliance with medical treatment, or unreliability. 
viii. 
Exposure to an investigational drug study within 30 days of the Baseline Visit. 
4.3 
Withdrawal of Subjects 
It is the right and duty of the Investigator to discontinue the study participation of a subject when the 
subject's health or well-being is threatened by continuation in the study. Such subjects should be 
withdrawn from the study. 
 
The following are circumstances that would result in the subject's discontinuation from the study: 
 
 
the subject experiences a serious adverse event rendering them unable to continue study participation; 
 
the subject is unable to physically or mentally tolerate the use of the test medication; 
 
an exclusion criterion becomes apparent at any time during the study; or 
 
the subject voluntarily withdraws. 
 
In the event of premature discontinuation from the study, the Investigator should determine the 
primary reason for discontinuation.  A subject who is withdrawn from the study prior to initiation of 
treatment may be replaced. 
 
 

 
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5.3 
Concomitant Medication/Treatment 
Please see Supplement I for a listing of prohibited medications.  Necessary therapies that will not 
interfere with the response to treatment may be provided at the discretion of the Investigator.  The 
use of any concurrent medication, prescription or over-the-counter drug, is to be recorded in the CRF 
along with the reason the medication was taken. 
 
5.4       Summary of known and potential risks 
5.5       Summary of Benefits 
There may be certain direct benefits derived from participating in this study. Such benefits include 
temporary, partial or complete, clearance of your acne lesions; however, it is possible that you 
receive no benefit. The results of this study may be useful in the development of a new therapy for 
others with similar conditions to yours. 

 
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7.2.3 Follow-up and Final Reports 
Subjects who have had a serious adverse event must be followed clinically until all parameters, 
including laboratory values (if applicable), have either returned to normal or are otherwise explained. 
 
If death was the outcome of the event on the initial SAE Report, a Follow-up/Final Report, including 
autopsy report, when performed, must be completed. 
 
8 
STATISTICS 
8.1 
Sample Size Justification 
A total of 10 subjects will be entered into the study.  This is a pilot study and a formal justification for 
the sample size is not provided.  The data from this study will provide important data for determining 
any trends regarding the safety and efficacy of study medication. 
 
8.2 
Analyses 
Statistical analyses will be conducted on an intent-to-treat basis (i.e., all enrolled subjects will be 
included in the analyses).  All statistical tests will be two-sided and interpreted at a 5% significance 
level.  Descriptive statistics (i.e., mean, standard deviation, etc.) will be provided for all continuous 
variables and frequencies for all categorical variables collected in this study.  These will be 
presented by treatment group.  Summary tables will be used to present patient population 
characteristics at Baseline; data from the study questionnaires will be included.  The incidence and 
severity of adverse and/or unexpected events will be tabulated and a complete listing of all reports of 
adverse and/or unexpected events will be presented. 
 
8.3 
Interim Analyses 
No interim analyses will be conducted. 
 
9 
RESPONSIBILITIES OF THE INVESTIGATOR 
9.1 
Good Clinical Practice 
Investigators must adhere to the procedures outlined in this Study Protocol.  The procedures set out 
in this study protocol, pertaining to the conduct, evaluation, and documentation of this study, are 
designed to ensure that the Investigators and CRO abide by GCP as described in the ICH 
Guidelines Topic E6: “Guideline for Good Clinical Practice.”  Compliance with these regulations also 
constitutes compliance with the ethical principles described in the current revision of the Declaration 
of Helsinki.  The study will also be carried out in keeping with local legal and regulatory requirements. 
 
9.2 
Ethics 
The appropriate IRB must review the Study Protocol and the Informed Consent Form prior to 
initiating the study.  Any significant modifications to the IRB-approved protocol or informed consent 
must be made in consultation with the IRB. 
 
9.3 
Confidentiality of Subjects 
Any information that identifies subjects with respect to this research study will be kept confidential.  
However, records identifying the subject may be inspected by representatives of the IRB, the Clinical 
Research Organization (or its designate) if applicable, and/or the FDA.  Subjects’ identity will remain 
strictly confidential during all record reviews, as well as in any publication that may result from this 
research.  Subjects will be identified by study code only; their names will not be used. 

 
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Dermatology Life Quality Index (DLQI) 

 
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The aim of this questionnaire is to measure how much your skin problem has affected your life 
OVER THE LAST WEEK.  Please circle one response for each question below. 
 
1. Over the last week, how itchy, sore, painful or stinging has your skin been? 
a. Very Much 
b. A Lot 
c. A Little 
d. Not at All 
 
2. Over the last week, how embarrassed or self-conscious have you been because of your 
skin? 
a. Very Much 
b. A Lot 
c. A Little 
d. Not at All 
 
3. Over the last week, how much has your skin interfered with you going shopping or 
looking after your home or garden? 
a. Very Much 
b. A Lot 
c. A Little 
d. Not at All 
e. Not Relevant 
 
4. Over the last week, how much has your skin influenced the clothes you wear? 
a. Very Much 
b. A Lot 
c. A Little 
d. Not at All 
e. Not Relevant 
 
5. Over the last week, how much has your skin affected any social or leisure activities? 
a. Very Much 
b. A Lot 
c. A Little 
d. Not at All 
e. Not Relevant 
 
 
6. Over the last week, how much has your skin made it difficult for you to do any sport? 
a. Very Much 
b. A Lot 
c. A Little 
d. Not at All 

 
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e. Not Relevant 
 
7. Over the last week, has your skin prevented you from working or studying? 
a. Yes 
b. No 
c. Not Relevant 
 
If “No”, over the last week how much has your skin been a problem at work 
or studying? 
a. A Lot 
b. A Little 
c. Not at All 
 
8. Over the last week, how much has your skin created problems with your partner or any 
of your close friends or relatives? 
a. Very Much 
b. A Lot 
c. A Little 
d. Not at All 
e. Not Relevant 
 
9. Over the last week, how much has your skin caused any sexual difficulties? 
a. Very Much 
b. A Lot 
c. A Little 
d. Not at All 
e. Not Relevant 
 
10. Over the last week, how much of a problem has the treatment of your skin been, for 
example by making your home messy, or by taking up time? 
a. Very Much 
b. A Lot 
c. A Little 
d. Not at All 
e. Not Relevant 
 
 
 
 
 
 
 
 
 
 

 
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