Clinical trial NCT06952517: Efficacy and Safety of Topical Clascoterone (WINLEVI) Cream 1% in Patients With Facial Acneiform Rosacea
Official title: Efficacy and Safety of Topical Clascoterone Cream 1% in Patients With Facial Acneiform Rosacea
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Papular-pustular Rosacea
Papulopustular Rosacea (PPR)
Papulopustular Rosacea
Keywords: rosacea
papulopustular rosacea
acneiform rosacea
PPR
Lead sponsor: Narrows Institute for Biomedical Research
Sponsor class: OTHER
Collaborators: name: Sun Pharmaceutical Industries Limited
First posted: 2025-05-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Biopsy proven reduction in size of sebaceous glands at the end of 12 weeks of treatment compared to the baseline.
timeFrame: From enrollment to end of treatment at 12 weeks
Secondary outcomes:
measure: Evaluation of safety and adverse events
timeFrame: From enrollment to end of treatment at 12 weeks
measure: Pre- and post-treatment digital photography with a camera (Canfield Scientific, Parsippany, NJ) to depict clinical improvement of rosacea.
timeFrame: From enrollment to end of treatment at 12 weeks
measure: Physician and study participants reported assessments at the end of the treatment compared to baseline
timeFrame: From enrollment to end of treatment at 12 weeks
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: New York Harbor VA Brooklyn Campus
state: New York
Study officials:
affiliation: SUNY Downstate Health Sciences University Department of Dermatology
name: Jared Jagdeo, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.