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Corticosteroid

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
Female or male subjects age 18-35 years
Subject must possess no scars or tattoos or other confounding dermatologic conditions on the face in the preauricular biopsy sites on the left and right face
Must not have
Subjects who are not willing to use the assigned study product to their face as instructed
Subjects with clinically significant unstable medical disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial aims to study the changes in the structure of facial oil-producing glands and the composition of facial oil before and after using a specific cream for 3 months.

Who is the study for?
This trial is for individuals with acne. Specific details about eligibility criteria are not provided, but typically participants must have a certain severity of acne and be in good general health.
What is being tested?
The study is testing the effects of Winlevi (Clascoterone) cream at 1% concentration on facial sebaceous glands and the composition of facial sebum after three months of treatment.
What are the potential side effects?
Potential side effects are not detailed here, but common ones for topical acne treatments include skin irritation, dryness, redness, and peeling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 35 years old.
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I have no scars, tattoos, or skin conditions near my ears.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am willing to use the study product on my face as instructed.
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I do not have any unstable health conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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 ) cream 1%Experimental Treatment1 Intervention

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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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