RESULTS
Patients
Overall, 1421 ITT patients 12 years or older enrolled in Phase 3 pivotal studies; 709 were randomized to apply clascoterone and 712 to vehicle (Figure 1). Baseline characteristics were previously reported.9 Patient disposition in the pivotal and LTE studies is summarized in Table 1. Patient baseline demographic characteristics were generally balanced between the treatment arms in the pivotal study and between patients originally randomized to clascoterone vs vehicle who continued into the LTE study. Patients' baseline characteristics were similar between the pivotal and LTE study populations, except that the proportion of non-Hispanic patients was higher in the LTE study relative to the combined pivotal studies (Table 2).
Short-Term Efficacy
The adjusted proportion of ITT patients achieving treatment success in the pivotal studies was higher among those receiving clascoterone vs vehicle beginning at week 8 (5.5% vs 3.7%, P = 0.13) and reached significance at week 12 (19.9% vs 7.7%,
