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Anti-androgen

Clascoterone Cream 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
Facial acne IGA score of 3 or 4
Must not have
Female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control
Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

"This trial is looking into acne, which is a common skin condition affecting both teenagers and adults. The study focuses on patients with different skin colors as previous research has been limited in this area. By examining

Who is the study for?
This trial is for individuals with skin of color who are experiencing acne. It's designed to add evidence on how effective and safe Clascoterone Cream 1% is in treating acne specifically in this group, as past studies haven't focused much on them.
What is being tested?
The study tests the efficacy and safety of Winlevi (clascoterone) 1% cream in treating acne among patients with skin of color. The goal is to provide real-world data that complements previous Phase III trials.
What are the potential side effects?
While specific side effects aren't listed here, typical reactions to topical acne treatments can include skin irritation, dryness, redness, or peeling at the site where the cream is applied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My acne is moderate to severe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not pregnant, breastfeeding, or if capable of becoming pregnant, I am using reliable birth control.
Select...
I do not have a skin condition that could affect acne assessment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
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

Awards & Highlights

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.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Winlevi (clascoterone) 1% creamExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Winlevi (clascoterone) 1% cream
2023
Completed Phase 4
~50

Find a Location

Who is running the clinical trial?

Sun Pharmaceutical Industries LimitedLead Sponsor
69 Previous Clinical Trials
13,785 Total Patients Enrolled
1 Trials studying Acne
201 Patients Enrolled for Acne
~0 spots leftby Dec 2024
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