To demonstrate the efficacy of Clascoterone cream 1% in reducing the size of sebaceous glands in study participants with acneiform rosacea.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Clascoterone 1% cream
New York Harbor VA Brooklyn Campus
Brooklyn, New York, United States
RECRUITINGBiopsy 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
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Time frame: From enrollment to end of treatment at 12 weeks