RECRUITING

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

Conditions

Papular-pustular Rosacea Papulopustular Rosacea (PPR)Papulopustular Rosacea rosacea acneiform rosacea PPR

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-03-14

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06952517

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Kayla N Zafar, BA

CONTACT

718-836-6600

kayla.zafar@va.gov

Principal Investigator

Jared Jagdeo, MD MS

PRINCIPAL_INVESTIGATOR

SUNY Downstate Health Sciences University Department of Dermatology

Study Locations (Sites)

New York Harbor VA Brooklyn Campus

Brooklyn, New York, 11209

United States

Collaborators and Investigators

Sponsor: Narrows Institute for Biomedical Research

Jared Jagdeo, MD MS, PRINCIPAL_INVESTIGATOR, SUNY Downstate Health Sciences University Department of Dermatology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-14

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2025-03-14

Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

rosacea
papulopustular rosacea
acneiform rosacea
PPR

Additional Relevant MeSH Terms

Papular-pustular Rosacea
Papulopustular Rosacea (PPR)
Papulopustular Rosacea