Efficacy was determined based on measurement of the overall severity of acne using the 5-point IGA, ranging from 0 (clear) to 4 (severe), which was assessed separately for the face and trunk at each study visit. The efficacy endpoint was the number of patients with each IGA severity score for each treatment area, as applicable, at each time point collected (baseline and long-term follow-up at months 1, 3, 6, and 9); the proportion of patients achieving IGA 0/1 for each treatment area is reported. The facial IGA score at the end-of-study visit of the Phase 3 study and the truncal IGA score during the first extension study visit were used as baseline data.
Statistical Analysis
All statistical analyses were performed using SAS® for Windows version 9.3. For demographic, efficacy, and safety data, continuous variables were described by descriptive statistics and categorical data by frequency counts and percentages of patients within each category. Sample size calculations were previously described.7 No interim analyses were performed. Missing data were not imputed.
Patient demographics are reported for the intention-to-treat (ITT) population, which included all enrolled individuals. Safety was assessed in all enrolled patients who received at least 1 application of clascoterone during the extension study (safety population). Efficacy was assessed in the per-protocol (PP) population, which included all patients who completed the extension study without significant protocol deviations; criteria for PP exclusion included failure to satisfy inclusion/exclusion criteria, use of prohibited medications, noncompletion of study, lack of compliance, or failure to treat individual with clascoterone.
As previously described,7 all TEAEs were coded using the Medical Dictionary for Regulatory Activities version 18.1 and were listed by preferred term and system organ class.
RESULTS
Patients and Demographics
Of 609 patients who entered the extension study,7 600 were greater than or equal to 12 years of age; of these, 311 were originally randomized to treatment with clascoterone and 289 to vehicle in the pivotal studies (Figure 2). The mean ± standard deviation age was 19.3 ± 6.2 in the ITT population (n = 600) and 19.8 ± 6.6 in the PP population (n = 319). The majority of patients were female (ITT, 62.2%; PP, 60.8%), and the population was predominantly White (Table 1). The safety population included 598 patients treated with clascoterone.
