Trial Outcomes & Findings for A Study to Evaluate the Reduction in Sebum (Skin Oil) Induced by Clascoterone Cream 1% in Acne Patients (NCT NCT06415279)

A Study to Evaluate the Reduction in Sebum (Skin Oil) Induced by Clascoterone Cream 1% in Acne Patients

The values represents the mean change from baseline. Casual sebum level is measured using a Sebumeter by means of grease-spot photometry. In this method, the measuring head of a cassette probe briefly exposes a section of a mat tape and brings it into contact with the sebum present on the surface of the forehead. As the tape absorbs sebum, it becomes increasingly transparent; conversely, lower levels of sebum result in less transparency. After contact, the tape is inserted into the device, which determines its transparency using a photocell-based light transmission measurement. The amount of transmitted light-reported in units from 0 to 350 µg/cm²-corresponds to the level of sebum present on the skin surface. The measurement has an estimated uncertainty of ±5%.

Changes in the skin microbiome - specifically Cutibacterium acnes - were evaluated by swabbing each subject's forehead to obtain microbiological samples. The swab samples were treated with metapolyzyme to lyse cells, after which DNA was isolated and quantified. DNA sequencing was used to quantify Cutibacterium acnes as relative abundance, defined as the proportion of total bacterial sequencing reads attributable to C. acnes (range, 0-1). For each sample, the abundance score of C. acnes was converted to relative abundance, and descriptive statistics (mean, median, and standard deviation) were calculated across time points. Statistical significance between pairs of time points was assessed using a Wilcoxon rank-sum test, implemented within the ggpubr plotting framework.