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

NCT06952517 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 1760535
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Papular-pustular Rosacea; Papulopustular Rosacea (PPR); Papulopustular Rosacea

Keywords

rosacea; papulopustular rosacea; acneiform rosacea; PPR

Outcome Measures

Primary Outcomes (1)

• Biopsy proven reduction in size of sebaceous glands at the end of 12 weeks of treatment compared to the baseline.

  We will perform both a paired and pooled statistical analysis. We will conduct a power analysis to determine statistical significance. For the paired analysis, we will calculate the average gland size per patient at baseline and again at the end of the treatment period from all the individual's biopsy sites. We will then calculate the percent reduction of sebaceous gland size between the two average sizes. Finally, we will calculate the average percent change across all participants. For the pooled analysis, we will calculate the average sebaceous gland size across all study participants before and after treatment. We will use these two values to calculate the percent change. We anticipate that the paired analysis will yield more meaningful results as the pooled analysis may not show significant change due to the variations between study participants used to calculate the averages.

  From enrollment to end of treatment at 12 weeks

Secondary Outcomes (3)

• Evaluation of safety and adverse events

  From enrollment to end of treatment at 12 weeks

• Pre- and post-treatment digital photography with a camera (Canfield Scientific, Parsippany, NJ) to depict clinical improvement of rosacea.

  From enrollment to end of treatment at 12 weeks

• Physician and study participants reported assessments at the end of the treatment compared to baseline

  From enrollment to end of treatment at 12 weeks

Study Arms (1)

Patients with Acneiform or Papulopustular Rosacea

EXPERIMENTAL

Patients with diagnosis of papulopustular or acneiform rosacea

Drug: Clascoterone Cream 1%

Interventions

Clascoterone Cream 1% DRUG

Clascoterone 1% cream

Also known as: WINLEVI

Patients with Acneiform or Papulopustular Rosacea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Narrows Institute for Biomedical Research: lead
• Sun Pharmaceutical Industries Limited: collaborator

Study Sites (1)

New York Harbor VA Brooklyn Campus

Brooklyn, New York, 11209, United States

RECRUITING

Related Publications (6)

• Liakou AI, Nyengaard JR, Bonovas S, Knolle J, Makrantonaki E, Zouboulis CC. Marked Reduction of the Number and Individual Volume of Sebaceous Glands in Psoriatic Lesions. Dermatology. 2016;232(4):415-24. doi: 10.1159/000445942. Epub 2016 Jun 2.

  PMID: 27250651 BACKGROUND

• Wilkin J, Dahl M, Detmar M, Drake L, Liang MH, Odom R, Powell F; National Rosacea Society Expert Committee. Standard grading system for rosacea: report of the National Rosacea Society Expert Committee on the classification and staging of rosacea. J Am Acad Dermatol. 2004 Jun;50(6):907-12. doi: 10.1016/j.jaad.2004.01.048. No abstract available.

  PMID: 15153893 BACKGROUND

• Buhl T, Sulk M, Nowak P, Buddenkotte J, McDonald I, Aubert J, Carlavan I, Deret S, Reiniche P, Rivier M, Voegel JJ, Steinhoff M. Molecular and Morphological Characterization of Inflammatory Infiltrate in Rosacea Reveals Activation of Th1/Th17 Pathways. J Invest Dermatol. 2015 Sep;135(9):2198-2208. doi: 10.1038/jid.2015.141. Epub 2015 Apr 7.

  PMID: 25848978 BACKGROUND

• Brelsford M, Beute TC. Preventing and managing the side effects of isotretinoin. Semin Cutan Med Surg. 2008 Sep;27(3):197-206. doi: 10.1016/j.sder.2008.07.002.

  PMID: 18786498 BACKGROUND

• Khalil NY, Darwish IA, Al-Qahtani AA. Isotretinoin. Profiles Drug Subst Excip Relat Methodol. 2020;45:119-157. doi: 10.1016/bs.podrm.2019.10.005. Epub 2019 Dec 6.

  PMID: 32164966 BACKGROUND

• Tan J, Schofer H, Araviiskaia E, Audibert F, Kerrouche N, Berg M; RISE study group. Prevalence of rosacea in the general population of Germany and Russia - The RISE study. J Eur Acad Dermatol Venereol. 2016 Mar;30(3):428-34. doi: 10.1111/jdv.13556.

  PMID: 26915718 BACKGROUND

MeSH Terms

Conditions

Rosacea

Interventions

Clascoterone

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jared Jagdeo, MD MS

  SUNY Downstate Health Sciences University Department of Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kayla N Zafar, BA

CONTACT

718-836-6600; kayla.zafar@va.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 1, 2025
• Study Start: March 14, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 30, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)