Trial Outcomes & Findings for A Study Evaluating the Efficacy and Safety of Clascoterone Cream 1% in Skin of Color Patients With Acne (NCT NCT06415305)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

Week 16

Results posted on

2026-01-16

Participant Flow

Participant milestones

Participant milestones
Measure	Winlevi (Clascoterone) 1% Cream Winlevi (clascoterone) 1% cream: Dosed twice daily (BID)
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study Evaluating the Efficacy and Safety of Clascoterone Cream 1% in Skin of Color Patients With Acne

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Winlevi (Clascoterone) 1% Cream n=9 Participants Winlevi (clascoterone) 1% cream: Dosed twice daily (BID)
Age, Continuous	24 years STANDARD_DEVIATION 9 • n=9 Participants
Sex: Female, Male Female	7 Participants n=9 Participants
Sex: Female, Male Male	2 Participants n=9 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=9 Participants
Race/Ethnicity, Customized Black	8 Participants n=9 Participants

PRIMARY outcome

Timeframe: Week 16

Outcome measures

Outcome measures
Measure	Winlevi (Clascoterone) 1% Cream n=9 Participants Winlevi (clascoterone) 1% cream: Dosed twice daily (BID)
The Primary Endpoint of This Study is the Percent of Patients Who Achieved Clear (0) or Almost Clear (1) on IGA Scale at Week 16	78 percentage of participants

SECONDARY outcome

Timeframe: Week 16

The data reports the average percent reduction in total lesion count form Baseline to Week 16

Outcome measures

Outcome measures
Measure	Winlevi (Clascoterone) 1% Cream n=9 Participants Winlevi (clascoterone) 1% cream: Dosed twice daily (BID)
Percent of Total Lesion Reduction at Week 16 Compared to Baseline	90.9 Mean % reduction in total lesion count Standard Deviation 10.7

SECONDARY outcome

Timeframe: Week 16

The data reported represents the average percent reduction in inflammatory lesion count form Baseline to Week 16

Outcome measures

Outcome measures
Measure	Winlevi (Clascoterone) 1% Cream n=9 Participants Winlevi (clascoterone) 1% cream: Dosed twice daily (BID)
Percent of Inflammatory Lesion Reduction at Week 16 Compared to Baseline	91.8 mean % reduction in inflamm lesion count Standard Deviation 11.1

SECONDARY outcome

Timeframe: Week 16

The average percent reduction in non-inflammatory lesion count form Baseline to Week 16

Outcome measures

Outcome measures
Measure	Winlevi (Clascoterone) 1% Cream n=9 Participants Winlevi (clascoterone) 1% cream: Dosed twice daily (BID)
Percent of Non-inflammatory Lesion Reduction at Week 16 Compared to Baseline	90.9 mean % reduction in non-inflamm lesion Standard Deviation 11.1

SECONDARY outcome

Timeframe: Week 52

The score in the scale ranges from 0-4. Lower score represents absence of erythema and higher score represents severe condition. The information presented represents the "Percentage of participant" with "Absent or Trace" erythema at Week 52

Outcome measures

Outcome measures
Measure	Winlevi (Clascoterone) 1% Cream n=4 Participants Winlevi (clascoterone) 1% cream: Dosed twice daily (BID)
Tolerability Measures of Erythema Based on 5-point Severity Scale	100 Percentage of participants

SECONDARY outcome

Timeframe: Week 52

The score in the scale ranges from 0-4. Lower score represents absence of dryness and higher score represents severe condition. The information presented represents the "Percentage of participant" with "Absent or Trace" Dryness at Week 52

Outcome measures

Outcome measures
Measure	Winlevi (Clascoterone) 1% Cream n=4 Participants Winlevi (clascoterone) 1% cream: Dosed twice daily (BID)
Tolerability Measures of Dryness Based on 5-point Severity Scale	100 Percentage of participants

SECONDARY outcome

Timeframe: Week 52

The score in the scale ranges from 0-4. Score 0 represents absence of peeling and Score 4 represents 'Extensive peeling'. The information presented represents the "Percentage of participant" with "Absent or Trace" peeling at week 52

Outcome measures

Outcome measures
Measure	Winlevi (Clascoterone) 1% Cream n=4 Participants Winlevi (clascoterone) 1% cream: Dosed twice daily (BID)
Tolerability Measures of Peeling Based on 5-point Severity Scale	100 percentage of participants

SECONDARY outcome

Timeframe: Week 52

The score in the scale ranges from 0-4. Score 0 represents absence of Oiliness and Score 4 represents severe condition. The information presented represents the "Percentage of participant" with "Absent or Trace" oiliness at week 52

Outcome measures

Outcome measures
Measure	Winlevi (Clascoterone) 1% Cream n=4 Participants Winlevi (clascoterone) 1% cream: Dosed twice daily (BID)
Assessment of Skin Oiliness Based on 5-point Severity Scale	100 percentage of participants

SECONDARY outcome

Timeframe: Week 52

The score in the scale ranges from 0-5. Lower score represents absence of discomfort and higher score represents severe condition. The information presented represents the "Percentage of participant" with "Absent or Trace" pruritus at week 52

Outcome measures

Outcome measures
Measure	Winlevi (Clascoterone) 1% Cream n=4 Participants Winlevi (clascoterone) 1% cream: Dosed twice daily (BID)
Tolerability Measures of Pruritus Based on 6-point Severity Scale	100 percentage of participants

SECONDARY outcome

Timeframe: Week 52

The score in the scale ranges from 0-5. Lower score represents absence of discomfort and higher score represents severe condition. The information presented represents the "Percentage of participant" with "Absent or Trace" burning/stinging at week 52

Outcome measures

Outcome measures
Measure	Winlevi (Clascoterone) 1% Cream n=4 Participants Winlevi (clascoterone) 1% cream: Dosed twice daily (BID)
Tolerability Measures of Burning/Stinging Based on 6-point Severity Scale	100 percentage of participants

Adverse Events

Winlevi (Clascoterone) 1% Cream

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

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

Restriction type: GT60