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

Narrows Institute for Biomedical Research

Status and phase

Enrolling

Phase 2

Conditions

Papular-pustular Rosacea

Papulopustular Rosacea

Papulopustular Rosacea (PPR)

Treatments

Drug: Clascoterone Cream 1%

Study type

Interventional

Funder types

Other

Industry

Identifiers

1760535

Details and patient eligibility

About

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

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.