Trial Outcomes & Findings for A Study Assessing the Efficacy and Safety of Combined Use of Clascoterone 1% Cream and Duac Gel (Benzoyl Peroxide/Clindamycin) for the Treatment of Acne (NCT NCT06336629)

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

10 participants

Primary outcome timeframe

Week 16

Results posted on

2025-07-17

Participant Flow

Participant milestones

Participant milestones
Measure	Winlevi (Clascoterone) 1% & Duac Gel Winlevi (clascoterone) 1% \& Duac gel: Participants will use Winlevi (clascoterone) 1% and Duac gel as per label
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study Assessing the Efficacy and Safety of Combined Use of Clascoterone 1% Cream and Duac Gel (Benzoyl Peroxide/Clindamycin) for the Treatment of Acne

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Winlevi (Clascoterone) 1% & Duac Gel n=9 Participants Winlevi (clascoterone) 1% \& Duac gel: Participants will use Winlevi (clascoterone) 1% and Duac gel as per label
Age, Continuous	33 years STANDARD_DEVIATION 17 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 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

Outcome measures
Measure	Winlevi (Clascoterone) 1% & Duac Gel n=9 Participants Winlevi (clascoterone) 1% \& Duac gel: Participants will use Winlevi (clascoterone) 1% and Duac gel as per label
The Primary Endpoint of This Study is the Percent of Patients Who Achieve Clear or Almost Clear on Investigator Global Assessment (IGA) Scale at Week 16.	100 Percentage of patients

SECONDARY outcome

Timeframe: Week 16

Outcome measures

Outcome measures
Measure	Winlevi (Clascoterone) 1% & Duac Gel n=9 Participants Winlevi (clascoterone) 1% \& Duac gel: Participants will use Winlevi (clascoterone) 1% and Duac gel as per label
Percent of Total Lesion Reduction at Week 16 Compared to Baseline	92 Percent change Standard Deviation 8.2

SECONDARY outcome

Timeframe: Week 16

Outcome measures

Outcome measures
Measure	Winlevi (Clascoterone) 1% & Duac Gel n=9 Participants Winlevi (clascoterone) 1% \& Duac gel: Participants will use Winlevi (clascoterone) 1% and Duac gel as per label
Percent of Inflammatory Lesion Reduction at Week 16 Compared to Baseline	96.4 Percent change Standard Deviation 6

SECONDARY outcome

Timeframe: Week 16

Outcome measures

Outcome measures
Measure	Winlevi (Clascoterone) 1% & Duac Gel n=9 Participants Winlevi (clascoterone) 1% \& Duac gel: Participants will use Winlevi (clascoterone) 1% and Duac gel as per label
Percent of Non-inflammatory Lesion Reduction at Week 16 Compared to Baseline.	86.1 Percent change Standard Deviation 15.3

SECONDARY outcome

Timeframe: Week 4,8,12,16

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 and 16

Outcome measures

Outcome measures
Measure	Winlevi (Clascoterone) 1% & Duac Gel n=9 Participants Winlevi (clascoterone) 1% \& Duac gel: Participants will use Winlevi (clascoterone) 1% and Duac gel as per label
Tolerability Measures of Erythema Based on 5-point Severity Scale Baseline	66 Percentage of participant Interval 31.0 to 91.0
Tolerability Measures of Erythema Based on 5-point Severity Scale Week 4	88 Percentage of participant Interval 51.0 to 99.0
Tolerability Measures of Erythema Based on 5-point Severity Scale Week 8	88 Percentage of participant Interval 51.0 to 99.0
Tolerability Measures of Erythema Based on 5-point Severity Scale Week 12	88 Percentage of participant Interval 51.0 to 99.0
Tolerability Measures of Erythema Based on 5-point Severity Scale Week 16	100 Percentage of participant Interval 63.0 to 100.0

SECONDARY outcome

Timeframe: Week 4,8,12,16

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 and 16.

Outcome measures

Outcome measures
Measure	Winlevi (Clascoterone) 1% & Duac Gel n=9 Participants Winlevi (clascoterone) 1% \& Duac gel: Participants will use Winlevi (clascoterone) 1% and Duac gel as per label
Tolerability Measures of Dryness Based on 5-point Severity Scale Baseline	100 Percentage of participant Interval 63.0 to 100.0
Tolerability Measures of Dryness Based on 5-point Severity Scale Week 4	100 Percentage of participant Interval 63.0 to 100.0
Tolerability Measures of Dryness Based on 5-point Severity Scale Week 8	100 Percentage of participant Interval 63.0 to 100.0
Tolerability Measures of Dryness Based on 5-point Severity Scale Week 12	100 Percentage of participant Interval 63.0 to 100.0
Tolerability Measures of Dryness Based on 5-point Severity Scale Week 16	100 Percentage of participant Interval 63.0 to 100.0

SECONDARY outcome

Timeframe: Week 4,8,12,16

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 and 16

Outcome measures

Outcome measures
Measure	Winlevi (Clascoterone) 1% & Duac Gel n=9 Participants Winlevi (clascoterone) 1% \& Duac gel: Participants will use Winlevi (clascoterone) 1% and Duac gel as per label
Tolerability Measures of Peeling Based on 5-point Severity Scale Baseline	100 percentage of participants Interval 63.0 to 100.0
Tolerability Measures of Peeling Based on 5-point Severity Scale Week 4	100 percentage of participants Interval 63.0 to 100.0
Tolerability Measures of Peeling Based on 5-point Severity Scale Week 8	100 percentage of participants Interval 63.0 to 100.0
Tolerability Measures of Peeling Based on 5-point Severity Scale Week 12	100 percentage of participants Interval 63.0 to 100.0
Tolerability Measures of Peeling Based on 5-point Severity Scale Week 16	100 percentage of participants Interval 63.0 to 100.0

SECONDARY outcome

Timeframe: Week 4,8,12,16

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 and 16

Outcome measures

Outcome measures
Measure	Winlevi (Clascoterone) 1% & Duac Gel n=9 Participants Winlevi (clascoterone) 1% \& Duac gel: Participants will use Winlevi (clascoterone) 1% and Duac gel as per label
Assessment of Skin Oiliness Based on 5-point Severity Scale Baseline	100 percentage of participants Interval 63.0 to 100.0
Assessment of Skin Oiliness Based on 5-point Severity Scale Week 4	100 percentage of participants Interval 63.0 to 100.0
Assessment of Skin Oiliness Based on 5-point Severity Scale Week 8	100 percentage of participants Interval 63.0 to 100.0
Assessment of Skin Oiliness Based on 5-point Severity Scale Week 12	100 percentage of participants Interval 63.0 to 100.0
Assessment of Skin Oiliness Based on 5-point Severity Scale Week 16	100 percentage of participants Interval 63.0 to 100.0

SECONDARY outcome

Timeframe: Week 4,8,12,16

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 at weeks 4,8,12 and 16

Outcome measures

Outcome measures
Measure	Winlevi (Clascoterone) 1% & Duac Gel n=9 Participants Winlevi (clascoterone) 1% \& Duac gel: Participants will use Winlevi (clascoterone) 1% and Duac gel as per label
Tolerability Measures of Burning/Stinging Based on 6-point Severity Scale Baseline	100 percentage of participants Interval 63.0 to 100.0
Tolerability Measures of Burning/Stinging Based on 6-point Severity Scale Week 4	100 percentage of participants Interval 63.0 to 100.0
Tolerability Measures of Burning/Stinging Based on 6-point Severity Scale Week 8	88 percentage of participants Interval 51.0 to 99.0
Tolerability Measures of Burning/Stinging Based on 6-point Severity Scale Week 12	100 percentage of participants Interval 63.0 to 100.0
Tolerability Measures of Burning/Stinging Based on 6-point Severity Scale Week 16	100 percentage of participants Interval 63.0 to 100.0

SECONDARY outcome

Timeframe: Week 4,8,12,16

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 and 16

Outcome measures

Outcome measures
Measure	Winlevi (Clascoterone) 1% & Duac Gel n=9 Participants Winlevi (clascoterone) 1% \& Duac gel: Participants will use Winlevi (clascoterone) 1% and Duac gel as per label
Tolerability Measures of Pruritus Based on 6-point Severity Scale Baseline	100 percentage of partiicipants Interval 63.0 to 100.0
Tolerability Measures of Pruritus Based on 6-point Severity Scale Week 4	100 percentage of partiicipants Interval 63.0 to 100.0
Tolerability Measures of Pruritus Based on 6-point Severity Scale Week 8	100 percentage of partiicipants Interval 63.0 to 100.0
Tolerability Measures of Pruritus Based on 6-point Severity Scale Week 12	88 percentage of partiicipants Interval 51.0 to 99.0
Tolerability Measures of Pruritus Based on 6-point Severity Scale Week 16	100 percentage of partiicipants Interval 63.0 to 100.0

Adverse Events

Winlevi (Clascoterone) 1% & Duac 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

Sun Pharmaceutical Industries Limited

Phone: 2266455645

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place