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NCT06952517PHASE2RecruitingAccepts Healthy Volunteers

Efficacy and Safety of Topical Clascoterone (WINLEVI) Cream 1% in Patients With Facial Acneiform Rosacea

Narrows Institute for Biomedical Research

Start Date

3/14/2025

Completion Date

9/30/2025

Summary

To demonstrate the efficacy of Clascoterone cream 1% in reducing the size of sebaceous glands in study participants with acneiform rosacea.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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 Criteria: * 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.

Interventions

DRUG

Clascoterone Cream 1%

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Conditions

Papular-pustular RosaceaPapulopustular Rosacea (PPR)Papulopustular Rosacea

Locations

New York Harbor VA Brooklyn Campus

Brooklyn, New York 11209

United States