Trial Outcomes & Findings for A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Adapalene 0.3% for the Treatment of Acne (NCT NCT06336603)

NCT ID: NCT06336603

Last Updated: 2025-10-09

Results Overview

The investigator will evaluate global acne severity using the Investigator Global Assessment scale, which ranges from 0 to 5, where 0 represents clear skin and 5 represents very severe acne

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: Week 16
• Results posted on: 2025-10-09

Participant Flow

Participant milestones

Measure	Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel Combined use of Winlevi twice daily and Adapalene once daily Winlevi (clascoterone) 1% \& Adapalene 0.3% gel: Participants will use Winlevi (clascoterone) 1% twice daily (BID) and Adapalene 0.3% once daily (QD)
Overall Study STARTED	20
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel Combined use of Winlevi twice daily and Adapalene once daily Winlevi (clascoterone) 1% \& Adapalene 0.3% gel: Participants will use Winlevi (clascoterone) 1% twice daily (BID) and Adapalene 0.3% once daily (QD)
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	2

Baseline Characteristics

A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Adapalene 0.3% for the Treatment of Acne

Baseline characteristics by cohort

Measure	Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel n=17 Participants Combined use of Winlevi twice daily and Adapalene once daily Winlevi (clascoterone) 1% \& Adapalene 0.3% gel: Participants will use Winlevi (clascoterone) 1% twice daily (BID) and Adapalene 0.3% once daily (QD)
Age, Continuous	22 years STANDARD_DEVIATION 10 • n=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	8 Participants n=93 Participants
Race/Ethnicity, Customized White	4 Participants n=93 Participants
Race/Ethnicity, Customized Black	4 Participants n=93 Participants
Race/Ethnicity, Customized Asian	4 Participants n=93 Participants
Race/Ethnicity, Customized Hispanic	5 Participants n=93 Participants

PRIMARY outcome

Timeframe: Week 16

The investigator will evaluate global acne severity using the Investigator Global Assessment scale, which ranges from 0 to 5, where 0 represents clear skin and 5 represents very severe acne

Outcome measures

Measure	Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel n=17 Participants Combined use of Winlevi twice daily and Adapalene once daily Winlevi (clascoterone) 1% \& Adapalene 0.3% gel: Participants will use Winlevi (clascoterone) 1% twice daily (BID) and Adapalene 0.3% once daily (QD)
The Primary Endpoint of This Study is the Percent of Patients Who Achieve Clear or Almost Clear on IGA at Week 16.	65 percentage of participants

SECONDARY outcome

Timeframe: Week 16

Outcome measures

Measure	Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel n=17 Participants Combined use of Winlevi twice daily and Adapalene once daily Winlevi (clascoterone) 1% \& Adapalene 0.3% gel: Participants will use Winlevi (clascoterone) 1% twice daily (BID) and Adapalene 0.3% once daily (QD)
Percent of Total Lesion Reduction at Week 16 Compared to Baseline	87.3 Percentage change Standard Deviation 11.4

SECONDARY outcome

Timeframe: Week 16

Outcome measures

Measure	Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel n=17 Participants Combined use of Winlevi twice daily and Adapalene once daily Winlevi (clascoterone) 1% \& Adapalene 0.3% gel: Participants will use Winlevi (clascoterone) 1% twice daily (BID) and Adapalene 0.3% once daily (QD)
Percent of Inflammatory Lesion Reduction at Week 16 Compared to Baseline	90.5 percentage change Standard Deviation 10.1

SECONDARY outcome

Timeframe: Week 16

Outcome measures

Measure	Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel n=17 Participants Combined use of Winlevi twice daily and Adapalene once daily Winlevi (clascoterone) 1% \& Adapalene 0.3% gel: Participants will use Winlevi (clascoterone) 1% twice daily (BID) and Adapalene 0.3% once daily (QD)
Percent of Non-inflammatory Lesion Reduction at Week 16 Compared to Baseline	84.8 percentage change Standard Deviation 13.5

SECONDARY outcome

Timeframe: Week 4,8,12,16, 20

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 weeks 4,8,12, 16 and 20

Outcome measures

Measure	Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel n=17 Participants Combined use of Winlevi twice daily and Adapalene once daily Winlevi (clascoterone) 1% \& Adapalene 0.3% gel: Participants will use Winlevi (clascoterone) 1% twice daily (BID) and Adapalene 0.3% once daily (QD)
Tolerability Measures of Erythema Based on 5-point Severity Scale Week 8	100 percentage of participants
Tolerability Measures of Erythema Based on 5-point Severity Scale Week 12	100 percentage of participants
Tolerability Measures of Erythema Based on 5-point Severity Scale Week 16	94 percentage of participants
Tolerability Measures of Erythema Based on 5-point Severity Scale Week 20	100 percentage of participants
Tolerability Measures of Erythema Based on 5-point Severity Scale Baseline	76 percentage of participants
Tolerability Measures of Erythema Based on 5-point Severity Scale Week 4	88 percentage of participants

SECONDARY outcome

Timeframe: Week 4,8,12,16, 20

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 weeks 4,8,12, 16 and 20

Outcome measures

Measure	Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel n=17 Participants Combined use of Winlevi twice daily and Adapalene once daily Winlevi (clascoterone) 1% \& Adapalene 0.3% gel: Participants will use Winlevi (clascoterone) 1% twice daily (BID) and Adapalene 0.3% once daily (QD)
Tolerability Measures of Dryness Based on 5-point Severity Scale Baseline	100 percentage of participants
Tolerability Measures of Dryness Based on 5-point Severity Scale Week 4	100 percentage of participants
Tolerability Measures of Dryness Based on 5-point Severity Scale Week 8	100 percentage of participants
Tolerability Measures of Dryness Based on 5-point Severity Scale Week 12	100 percentage of participants
Tolerability Measures of Dryness Based on 5-point Severity Scale Week 16	100 percentage of participants
Tolerability Measures of Dryness Based on 5-point Severity Scale Week 20	100 percentage of participants

SECONDARY outcome

Timeframe: Week 4,8,12,16, 20

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 weeks 4,8,12,16 and 20

Outcome measures

Measure	Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel n=17 Participants Combined use of Winlevi twice daily and Adapalene once daily Winlevi (clascoterone) 1% \& Adapalene 0.3% gel: Participants will use Winlevi (clascoterone) 1% twice daily (BID) and Adapalene 0.3% once daily (QD)
Tolerability Measures of Peeling Based on 5-point Severity Scale Week 4	100 percentage of participants
Tolerability Measures of Peeling Based on 5-point Severity Scale Week 8	100 percentage of participants
Tolerability Measures of Peeling Based on 5-point Severity Scale Week 12	100 percentage of participants
Tolerability Measures of Peeling Based on 5-point Severity Scale Baseline	100 percentage of participants
Tolerability Measures of Peeling Based on 5-point Severity Scale Week 16	100 percentage of participants
Tolerability Measures of Peeling Based on 5-point Severity Scale Week 20	100 percentage of participants

SECONDARY outcome

Timeframe: Week 4,8,12,16, 20

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 weeks 4,8,12,16 and 20

Outcome measures

Measure	Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel n=17 Participants Combined use of Winlevi twice daily and Adapalene once daily Winlevi (clascoterone) 1% \& Adapalene 0.3% gel: Participants will use Winlevi (clascoterone) 1% twice daily (BID) and Adapalene 0.3% once daily (QD)
Assessment of Skin Oiliness Based on 5-point Severity Scale Baseline	76 percentage of participants
Assessment of Skin Oiliness Based on 5-point Severity Scale Week 4	82 percentage of participants
Assessment of Skin Oiliness Based on 5-point Severity Scale Week 8	94 percentage of participants
Assessment of Skin Oiliness Based on 5-point Severity Scale Week 12	94 percentage of participants
Assessment of Skin Oiliness Based on 5-point Severity Scale Week 16	94 percentage of participants
Assessment of Skin Oiliness Based on 5-point Severity Scale Week 20	94 percentage of participants

SECONDARY outcome

Timeframe: Week 4,8,12,16, 20

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 weeks 4,8,12,16 and 20

Outcome measures

Measure	Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel n=17 Participants Combined use of Winlevi twice daily and Adapalene once daily Winlevi (clascoterone) 1% \& Adapalene 0.3% gel: Participants will use Winlevi (clascoterone) 1% twice daily (BID) and Adapalene 0.3% once daily (QD)
Tolerability Measures of Burning/Stinging Based on 6-point Severity Scale Baseline	100 percentage of participants
Tolerability Measures of Burning/Stinging Based on 6-point Severity Scale Week 4	100 percentage of participants
Tolerability Measures of Burning/Stinging Based on 6-point Severity Scale Week 8	94 percentage of participants
Tolerability Measures of Burning/Stinging Based on 6-point Severity Scale Week 12	94 percentage of participants
Tolerability Measures of Burning/Stinging Based on 6-point Severity Scale Week 16	100 percentage of participants
Tolerability Measures of Burning/Stinging Based on 6-point Severity Scale Week 20	100 percentage of participants

SECONDARY outcome

Timeframe: Week 4,8,12,16, 20

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 weeks 4,8,12,16 and 20

Outcome measures

Measure	Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel n=17 Participants Combined use of Winlevi twice daily and Adapalene once daily Winlevi (clascoterone) 1% \& Adapalene 0.3% gel: Participants will use Winlevi (clascoterone) 1% twice daily (BID) and Adapalene 0.3% once daily (QD)
Tolerability Measures of Pruritus Based on 6-point Severity Scale Week 20	100 percentage of participants
Tolerability Measures of Pruritus Based on 6-point Severity Scale Baseline	94 percentage of participants
Tolerability Measures of Pruritus Based on 6-point Severity Scale Week 4	88 percentage of participants
Tolerability Measures of Pruritus Based on 6-point Severity Scale Week 8	88 percentage of participants
Tolerability Measures of Pruritus Based on 6-point Severity Scale Week 12	94 percentage of participants
Tolerability Measures of Pruritus Based on 6-point Severity Scale Week 16	94 percentage of participants

Adverse Events

Winlevi (Clascoterone) 1% & Adapalene 0.3% Gel

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

Phone: 9122 66455645

Email: Clinical.Trial@sunpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place