Randomized, Phase 2, Dose-Ranging Study in the Treatment of Rosacea With Encapsulated Benzoyl Peroxide Gel

microcapsules. The microcapsules create an imperceptible barrier between the active ingredient and the skin. This technology was previously demonstrated to improve tolerance and efficacy in acne patients.¹³

Statistical processing for the intent to treat population was performed using SAS^®, Version 9.2, or later. Descriptive statistics included the number of subjects (N), mean, median, standard deviation (SD), minimum (Min), and maximum (Max) for continuous variables and frequency counts, and percentages for categorical variables. The statistical significance for the proportion of subjects with the primary measure of success were derived from a model with factors of treatment, analysis center, and baseline IGA using SAS PROC GENMOD with binomial distribution, logit link, and likelihood ratio test. An analysis of covariance with factors of treatment, analysis center, and baseline IGA or baseline inflammatory lesion count using SAS PROC GLM provided the P-values for the percent change in inflammatory lesion count when baseline IGA or inflammatory lesion count was the covariate, respectively.

Primary efficacy end points are summarized in Table 2 and P-values are summarized in Table 3. Both E-BPO formulations significantly reduced inflammatory lesions (Figure 1). There was a median reduction of 10 lesions in the vehicle group compared to 12.5 for 1% E-BPO and 15 for the 5% E-BPO formulation. 5% E-BPO was significantly superior to vehicle for IGA and showed a trend for superiority for the 1% formulation.