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%
Conditions
Papular-pustular RosaceaPapulopustular Rosacea (PPR)Papulopustular Rosacea
Locations
New York Harbor VA Brooklyn Campus
Brooklyn, New York 11209
United States