Clascoterone + Adapalene for Acne

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Sun Pharmaceutical Industries Limited

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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 Adapalene 0.3% gel in combination to emulate real life practice.

Eligibility Criteria

This trial is for individuals with acne vulgaris. Participants should be willing to apply two topical treatments, Clascoterone 1% cream and Adapalene 0.3% gel, as part of their daily skincare routine.

Inclusion Criteria

My acne severity is moderate to severe.

I am 12 years or older and can visit the clinic for treatment.

I am a woman who can have children, have a negative pregnancy test, and will use birth control during the study.

+2 more

Exclusion Criteria

Exposure to an investigational drug study within 30 days of the Baseline Visit

Evidence of recent alcohol or drug abuse

History of poor cooperation, non-compliance with medical treatment, or unreliability

+5 more

Participant Groups

The study tests the effectiveness of combining Winlevi (Clascoterone) cream with Adapalene gel in treating acne, which mimics real-life treatment practices.

1Treatment groups

Experimental Treatment

Group I: Winlevi (clascoterone) 1% & Adapalene 0.3% gelExperimental Treatment1 Intervention

Combined use of Winlevi twice daily and Adapalene once daily