Status:
RECRUITING
Efficacy and Safety of Topical Clascoterone (WINLEVI) Cream 1% in Patients With Facial Acneiform Rosacea
Lead Sponsor:
Narrows Institute for Biomedical Research
Collaborating Sponsors:
Sun Pharmaceutical Industries Limited
Conditions:
Papular-pustular Rosacea
Papulopustular Rosacea (PPR)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To demonstrate the efficacy of Clascoterone cream 1% in reducing the size of sebaceous glands in study participants with acneiform rosacea.
Eligibility Criteria
Inclusion
- Men and women ages 18+.
- Diagnosis of rosacea type 2 (papulopustular).
- Available and willing to comply with study instructions and attend all study visits.
- Able and willing to provide written and verbal informed consent.
- Subject has used the same type and brand of make-up, other facial products, and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one month prior to the baseline visit and agrees to continue his/her other general skin and hair care products and regimen for the entire study.
Exclusion
- Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy.
- Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- Pregnant, lactating, or is planning to become pregnant during the study.
- Subject is currently enrolled in an investigational drug or device study.
- Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (baseline).
- Study participant has facial hair that could interfere with the study assessments in the opinion of the investigator.
- Study participant is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
- Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles.
- Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial.
Key Trial Info
Start Date :
March 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06952517
Start Date
March 14 2025
End Date
September 30 2025
Last Update
May 6 2025
Active Locations (1)
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1
New York Harbor VA Brooklyn Campus
Brooklyn, New York, United States, 11209