A Phase 2 interventional study of Clascoterone Cream 1% in Papular-pustular Rosacea, Papulopustular Rosacea (PPR) and Papulopustular Rosacea, sponsored by Narrows Institute for Biomedical Research. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-06.
Sponsored by Narrows Institute for Biomedical Research · Phase 2, Interventional, and Treatment
To demonstrate the efficacy of Clascoterone cream 1% in reducing the size of sebaceous glands in study participants with acneiform rosacea.
231 studies on the registry are indexed under Rosacea; 20 are open to participants now.
This study's planned enrollment of 20 is below the median of 61 across 199 interventional studies indexed under Rosacea.
Browse Rosacea studies →Narrows Institute for Biomedical Research is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Patients with diagnosis of papulopustular or acneiform rosacea
Drug: Clascoterone Cream 1%
Clascoterone 1% cream
Also known as: WINLEVI
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.
Time frame: From enrollment to end of treatment at 12 weeks
Evaluation of safety and adverse events
We plan to calculate the incidence of adverse events. Study participants will be instructed to keep a log of all adverse events.
Time frame: 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.
Pre- and post-treatment digital photography with a camera (Canfield Scientific, Parsippany, NJ) to depict clinical improvement of rosacea.
Time frame: From enrollment to end of treatment at 12 weeks
Physician and study participants reported assessments at the end of the treatment compared to baseline
A modified, succinct version of the Rosacea clinical scorecard as proposed by the Report of the National Rosacea Society Expert Committee on the Classification and Staging of sRosacea will be used to assess these measures. Physicians and study participants will be asked to grade the rosacea at baseline and at the end of the treatment based on the following scale: * Subtype 1: Erythematotelangiectatic: 1=Absent, 2=Mild, 3=Moderate, 4=Severe * Subtype 2: Papulopustular: 1=Absent, 2=Mild, 3=Moderate, 4=Severe * Subtype 3: Phymatous: 1=Absent, 2=Mild, 3=Moderate, 4=Severe * Global Assessment: 1=Absent, 2=Mild, 3=Moderate, 4=Severe
Time frame: From enrollment to end of treatment at 12 weeks
Plan to share: No — IPD may not be shared because this study is conducted at a VA hospital with a small sample size
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Studies of the drug tested here: Clascoterone
Narrows Institute for Biomedical Research