Efficacy and Safety of Topical Clascoterone (WINLEVI) Cream 1% in Patients With Facial Acneiform Rosacea: A Phase 2 Clinical Trial

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 hairproducts (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one month priorto the baseline visit and agrees to continue his/her other general skin and haircare products and regimen for the entire study.

Exclusion Criteria:

• Subject has any skin pathology or condition that could interfere with the evaluationof 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 unsafefor 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 aninvestigational device within 30 days prior to the initiation of treatment (baseline).

• Study participant has facial hair that could interfere with the study assessments inthe opinion of the investigator.

• Study participant is unable to communicate or cooperate with the investigator due tolanguage problems, poor mental development, or impaired cerebral function.

• Subject has known hypersensitivity or previous allergic reaction to any of theactive or inactive components of the test articles.

• Subject has the need or plans to be exposed to artificial tanning devices orexcessive sunlight during the trial.