CompletedPhase 4

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

United States10 participantsStarted 2023-11-15

Plain-language summary

Winlevi is the first topical anti androgen and sebum inhibitor approved for acne vulgaris. There is no study assessing Winlevi in combination treatment for acne .Therefore this study assesses Winlevi with Duac gel in combination to emulate real life practice.

Who can participate

Age range12 Years

SexALL

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Inclusion criteria

✓. postmenopausal for at least 12 months prior to study drug administration;
✓. without a uterus and/or both ovaries; or
✓. Has been surgically sterile for at least 6 months prior to study drug administration.
✓. Hormonal methods or intrauterine device in use \> 90 days prior to study drug administration;
✓. Barrier methods plus spermicide in use at least 14 days prior to study drug administration; or
✓. Vasectomized partner (vasectomy must be performed 3 months prior to first study drug administration or in the alternative a zero sperm count will suffice).

What they're measuring

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.

Timeframe: Week 16

Trial details

NCT IDNCT06336629

SponsorSun Pharmaceutical Industries Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-10

Results submitted2025-06-30

View on ClinicalTrials.gov More Acne Vulgaris trials