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

Launched by NARROWS INSTITUTE FOR BIOMEDICAL RESEARCH · Apr 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new cream called Clascoterone (WINLEVI) to see if it can effectively reduce the size of sebaceous glands in patients with a specific type of rosacea known as papulopustular rosacea, which is characterized by red bumps and pustules on the face. The goal is to determine if this cream can help improve the symptoms of this condition.

To participate in the study, you need to be at least 18 years old and have a diagnosis of papulopustular rosacea. You'll also need to be available for all study visits and follow certain guidelines regarding the use of skincare and hair products during the trial. Participants will apply the cream as directed and attend regular check-ups to monitor their progress. It's important to note that certain individuals, such as those who are pregnant or have specific skin conditions, will not be eligible to join the study. If you think you might be a good fit, this trial could provide an opportunity to explore a new treatment for rosacea.

Gender

ALL

Eligibility criteria

• 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.