Trial Outcomes & Findings for A Study to Evaluate the Impact of Clascoterone 1% Cream on Skin Barrier Properties in Acne Prone Patients (NCT NCT06415292)
NCT ID: NCT06415292
Last Updated: 2025-03-04
Results Overview
The Corneometer measures skin hydration with a range of 0- 1000 MicroSiemens, where 0 is lowest and 1000 is highest hydration
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
Week 2
Results posted on
2025-03-04
Participant Flow
Unit of analysis: Split face
Participant milestones
| Measure |
Winlevi (Clascoterone) 1% Treated
This study involved 50 subjects. Splitface design- Subjects applied Winlevi(clascoterone) cream 1%, twice daily to the randomized half face following cleansing, everymorning and evening. No study product was applied to the untreated side of the face
|
|---|---|
|
Overall Study
STARTED
|
50 100
|
|
Overall Study
Winlevi (Clascoterone) 1% Un-treated Side (UT)
|
50 50
|
|
Overall Study
Winlevi (Clascoterone) 1% Treated Side (T)
|
50 50
|
|
Overall Study
COMPLETED
|
49 98
|
|
Overall Study
NOT COMPLETED
|
1 2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Impact of Clascoterone 1% Cream on Skin Barrier Properties in Acne Prone Patients
Baseline characteristics by cohort
| Measure |
Winlevi (Clascoterone) 1% Treated
n=50 Participants
Winlevi (clascoterone) 1% cream: Split face. Blinded study treatment product to be applied to the randomized half face
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
African Americans
|
19 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasians
|
30 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Week 2The Corneometer measures skin hydration with a range of 0- 1000 MicroSiemens, where 0 is lowest and 1000 is highest hydration
Outcome measures
| Measure |
Winlevi (Clascoterone) 1% Un-treated Side (UT)
n=50 Participants
Splitface design-no study product was applied to the untreated side of the face
|
Winlevi (Clascoterone) 1% Treated Side (T)
n=50 Participants
Splitface design- Subjects applied Winlevi (clascoterone) cream 1%, twice daily to the randomized half face following cleansing, every morning and evening.
|
|---|---|---|
|
The Primary Endpoint is the Change in Corneometry Reading Between the Two Sides of the Face Treated With Winlevi Versus no Treatment.
|
131.27 microSiemens (μS)
Standard Deviation 42.92
|
113.94 microSiemens (μS)
Standard Deviation 36.61
|
SECONDARY outcome
Timeframe: Week 2The instrument measures trans epidermal water loss (abbreviated as TEWL) which ranges from minimum 0 (no trans epidermal water loss) to maximum 100 (high trans epidermal water loss)
Outcome measures
| Measure |
Winlevi (Clascoterone) 1% Un-treated Side (UT)
n=50 Participants
Splitface design-no study product was applied to the untreated side of the face
|
Winlevi (Clascoterone) 1% Treated Side (T)
n=50 Participants
Splitface design- Subjects applied Winlevi (clascoterone) cream 1%, twice daily to the randomized half face following cleansing, every morning and evening.
|
|---|---|---|
|
Change in TEWL Reading Between the Two Sides of the Face Treated With Winlevi Versus no Treatment
|
9.94 g/h/m²
Standard Deviation 2.59
|
9.92 g/h/m²
Standard Deviation 2.88
|
Adverse Events
Winlevi (Clascoterone) 1% Treated
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Winlevi (Clascoterone) 1% Treated
n=50 participants at risk
Winlevi (clascoterone) 1% cream: Split face. Blinded study treatment product to be applied to the randomized half face
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Covid 19
|
2.0%
1/50 • Number of events 1 • 2 Weeks
There was only one patient that report Covid 19 during the study, this patient applied winlevi to one side of the face and the other side was left untreated.
|
Additional Information
Head-Regulatory Affairs
Sun Pharmaceutical Industries Limited
Phone: 2266455645
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place