Comparisons between clascoterone and vehicle were analyzed using a logistic regression model for the proportion of subjects achieving "success" (defined by an IGA score 0/1 with a ≥2-point reduction in IGA score from baseline) and an analysis of covariance model for change and percent CFB in NILCs, ILCs, and TLCs, as previously described.2 A multiple imputation method was used to impute missing values. Adjusted proportions and least-squares means derived from the models are presented with 2-sided nominal P-values; in the primary study, primary and secondary efficacy endpoints were analyzed using a prespecified hierarchical testing procedure for multiplicity control of type 1 error, which did not apply to this post hoc analysis.
Safety analyses included all patients who received ≥1 application of the test treatment. The LSRs were summarized by the frequency of each individual reaction by treatment group and severity at each visit. The TEAEs were summarized by treatment group at each visit; the number and proportion of subjects with any TEAE and the number of TEAEs were summarized by MedDRA system organ class and preferred term, seriousness, relationship to test article, and severity.
Safety analyses included all patients who received ≥1 application of the test treatment. The LSRs were summarized by the frequency of each individual reaction by treatment group and severity at each visit. The TEAEs were summarized by treatment group at each visit; the number and proportion of subjects with any TEAE and the number of TEAEs were summarized by MedDRA system organ class and preferred term, seriousness, relationship to test article, and severity.
RESULTS
Patient Disposition and Demographics
Overall, 1421 patients ≥12 years of age were randomized; 709 patients were allocated to treatment with 1% clascoterone cream and 712 patients to vehicle. Among patients treated with clascoterone and vehicle, 63.9% and 60.4% were female, and 91.0% and 90.3% were white, with mean ± standard deviation (SD) age 19.8 ± 6.1 and 19.5 ± 6.1 years, respectively (Table 1). Baseline characteristics were generally balanced between treatment arms. At baseline, the IGA score was moderate (3) in 82.5% vs 84.1% and severe (4) in 17.5% vs 15.9% of patients treated with clascoterone vs vehicle, respectively (Table 1). The most frequent LSRs at baseline were erythema and scaling/dryness.
Overall, 1421 patients ≥12 years of age were randomized; 709 patients were allocated to treatment with 1% clascoterone cream and 712 patients to vehicle. Among patients treated with clascoterone and vehicle, 63.9% and 60.4% were female, and 91.0% and 90.3% were white, with mean ± standard deviation (SD) age 19.8 ± 6.1 and 19.5 ± 6.1 years, respectively (Table 1). Baseline characteristics were generally balanced between treatment arms. At baseline, the IGA score was moderate (3) in 82.5% vs 84.1% and severe (4) in 17.5% vs 15.9% of patients treated with clascoterone vs vehicle, respectively (Table 1). The most frequent LSRs at baseline were erythema and scaling/dryness.
Efficacy
Clascoterone cream remained significantly more effective at week 12 compared with vehicle cream in the subgroup of patients 12 years of age and older. At week 12, 19.9% of clascoterone-treated patients achieved success based on IGA compared with 7.7% of vehicle-treated patients (P<0.0001; Figure 1). At week 12, the absolute CFB for patients treated with clascoterone vs vehicle was -20.8 vs -11.9 (percent change, -30.8% vs -18.3%; P<0.0001) for NILCs (Figures 2A and 2B) and -19.7 vs -14.0 (percent change, -46.2% vs -32.5%; P<0.0001) for ILCs, respectively (Figures 3A and 3B). The absolute CFB in TLC was -40.0 vs -26.1 for clascoterone-treated vs vehicle-treated patients (percent change, -37.8% vs -25.1%; P<0.0001) (Figures 4A and 4B).
