← Back to Search

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 up to 5 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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

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) 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
13,755 Total Patients Enrolled
1 Trials studying Acne
201 Patients Enrolled for Acne
~7 spots leftby Feb 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top