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Retinoid

Clascoterone + Adapalene 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, 20
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

Summary

This trial is looking at using Winlevi, a new acne treatment, along with Adapalene gel to see how well they work together in treating acne. There haven't been any studies on

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 Adapalene 0.3% gel, as part of their daily skincare routine.
What is being tested?
The study tests the effectiveness of combining Winlevi (Clascoterone) cream with Adapalene gel in treating acne, which mimics real-life treatment practices.
What are the potential side effects?
Potential side effects may include skin irritation, dryness, redness, burning sensation where the medication is applied.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4,8,12,16, 20
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4,8,12,16, 20 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The primary endpoint of this study is the percent of patients who achieve clear or almost clear on IGA at week 16.
Secondary study objectives
Assessment of skin oiliness based on 5-point severity scale
Tolerability measures of burning/stinging based on 6-point severity scale
Tolerability measures of dryness based on 5-point severity scale
+3 more

Side effects data

From 2012 Phase 4 trial • 20 Patients • NCT01504204
30%
Dryness
20%
itching
10%
redness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Medication Without Samples
Medication With Sample and Demonstration

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

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

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Who is running the clinical trial?

Sun Pharmaceutical Industries LimitedLead Sponsor
69 Previous Clinical Trials
13,775 Total Patients Enrolled
1 Trials studying Acne
201 Patients Enrolled for Acne
~10 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
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