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

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

Recruiting
18 years and older
All
Phase 2

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Overview

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

Eligibility

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.

Study details
    Papular-pustular Rosacea
    Papulopustular Rosacea (PPR)
    Papulopustular Rosacea

NCT06952517

Narrows Institute for Biomedical Research

10 May 2025

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