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

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

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

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.