Topical Clascoterone Cream for Treating Acneiform Rosacea
Efficacy and Safety of Topical Clascoterone Cream 1% in Patients With Facial Acneiform Rosacea
This study is testing if a new cream can help people with acne-like rosacea by reducing the size of the oil glands in their skin.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Narrows Institute for Biomedical Research Academic / other |
| Locations | 1 site (Brooklyn, New York) |
| Trial ID | NCT06952517 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of Clascoterone cream 1% in patients diagnosed with papulopustular rosacea. The study aims to demonstrate the cream's ability to reduce the size of sebaceous glands, which are associated with the condition. Participants will be required to comply with study instructions and attend all visits while maintaining their usual skincare routines. The trial is interventional and is currently in Phase 2.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 18 and older with a diagnosis of papulopustular rosacea.
Not a fit: Patients with other skin conditions that could interfere with the evaluation or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of acneiform rosacea for patients.
How similar studies have performed: While this approach is being tested in this specific context, similar treatments have shown promise in managing rosacea in other studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Brooklyn, New York
- New York Harbor VA Brooklyn Campus — Brooklyn, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jared Jagdeo, MD MS — SUNY Downstate Health Sciences University Department of Dermatology
- Study coordinator: Kayla N Zafar, BA
- Email: kayla.zafar@va.gov
- Phone: 718-836-6600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.