← Back to Search

Anti-androgen

Winlevi (clascoterone) 1% & Duac gel for Acne

Phase 4

Waitlist Available

Research Sponsored by Sun Pharmaceutical Industries Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 4,8,12,16

Awards & highlights

Study Summary

This trial is testing a new acne treatment called Winlevi in combination with Duac gel to see how well they work together. Winlevi is the first topical anti-androgen and sebum inhibitor

Who is the study for?

This trial is for individuals with acne vulgaris. Participants should be willing to apply two topical treatments, Clascoterone 1% Cream and Duac Gel (Benzoyl Peroxide/Clindamycin), as part of their daily skincare routine.Check my eligibility

What is being tested?

The study tests the effectiveness of combining Winlevi (clascoterone) cream with Duac gel on acne. It's a new approach since there's no prior research on using these two treatments together for better results in real-life settings.See study design

What are the potential side effects?

Possible side effects may include skin irritation, dryness, redness, peeling at the application site from both Clascoterone and Duac Gel. More serious reactions are rare but can occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 4,8,12,16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 4,8,12,16

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4,8,12,16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The primary endpoint of this study is the percent of patients who achieve clear or almost clear on IGA at week 16.

Secondary outcome measures

Assessment of skin oiliness based on 5-point severity scale

Percent of inflammatory lesion reduction at week 16 compared to baseline

Percent of non-inflammatory lesion reduction at week 16 compared to baseline.

+6 more

Trial Design

1Treatment groups

Experimental Treatment

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sun Pharmaceutical Industries LimitedLead Sponsor

64 Previous Clinical Trials

13,501 Total Patients Enrolled

1 Trials studying Acne

201 Patients Enrolled for Acne

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are prospective patients still eligible to participate in this ongoing medical study?

"As per clinicaltrials.gov, the ongoing trial is not presently open for participant recruitment. The trial's initial posting was on November 15th, 2023, with the latest update performed on March 27th, 2024. Despite this trial being inactive in terms of recruitment at present, there are currently 38 alternative trials welcoming participants."

Answered by AI

What are the potential risks associated with Winlevi (clascoterone) 1% & Duac gel when used by individuals?

"Given that this investigation is classified as a Phase 4 trial, denoting an approved treatment, our panel at Power rates the safety of Winlevi (clascoterone) 1% & Duac gel with a score of 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Duac Gel (Benzoyl Peroxide/Clindamycin) for the Treatment of Acne". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06336629.

All > Acne