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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
Subjects who agree to use only the study products for acne treatment. No other medicated cleansers or moisturizers or acne treatments of any kind are allowed
Must not have
Subjects who are not willing to use the assigned study product to their face as instructed
Subjects who have acne nodules/cysts representative of severe acne
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 52
Awards & highlights

Summary

"This trial aims to study how a newly FDA approved acne medication, clascoterone cream 1%, helps in reducing sebum production, which is responsible for the growth of acne-causing bacteria.

Who is the study for?
This trial is for individuals with acne, aiming to test if Clascoterone Cream 1% can reduce skin oil production. Participants should have a diagnosis of acne and be willing to apply the cream as directed.
What is being tested?
The study tests Clascoterone Cream 1%, an FDA-approved medication for acne that may work by reducing sebum (skin oil) production, which could starve and kill the bacteria responsible for acne.
What are the potential side effects?
Potential side effects of Clascoterone Cream include skin irritation, redness, itching or burning at the application site. More serious side effects are rare but might involve hormonal imbalances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to only use the study's acne products and no other treatments.

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 have severe acne with nodules or cysts.
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I am currently experiencing an acne outbreak.
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I have a surgery or medical procedure planned during the study.
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I am not on medication that could hide side effects or affect study results.
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I started or plan to change hormone treatments or birth control recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 52 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 efficacy endpoint is the reduction in causal sebum measurements from the forehead obtained with a sebumeter during the study.
Secondary outcome measures
The secondary efficacy endpoint is the changes in the facial microbiome induced by 8, 12, and 52 weeks of clascoterone 1% cream application.

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
68 Previous Clinical Trials
13,553 Total Patients Enrolled
1 Trials studying Acne
201 Patients Enrolled for Acne
~15 spots leftby Feb 2025
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