P <0.0001, Table 3), as previously reported.9 Clascoterone treatment also resulted in significantly larger reductions in lesion counts compared with the vehicle at week 12 (Table 4), as previously reported.9 The absolute and percent change from baseline in NILC reached statistical significance between patients treated with clascoterone vs vehicle at week 12. For ILC and TLC, the treatment difference for clascoterone vs placebo became significant starting at week 8 for absolute and percent change from baseline (Table 4).
Long-Term Efficacy
The unadjusted proportion of ITT patients previously treated with clascoterone who achieved facial IGA 0/1 increased from 42/311 (13.5%) at extension day 0 to 93/311 (29.9%) at extension day 274, with improvement observed at each visit from extension day 29. Similarly, the unadjusted proportion of ITT patients previously treated with vehicle and switched to clascoterone in the LTE study who achieved facial IGA 0/1 increased from 18/289 (6.2%) at extension day 0 to 88/289 (30.4%) at extension day 274, with improvement observed at each visit (Figure 2).
Among ITT patients who treated truncal acne, the unadjusted proportion with truncal IGA 0/1 increased from 12/246 (4.9%) at extension day 0 to 78/246 (31.7%) on extension day 274, with improvement observed at each visit beginning at extension day 29. Although patients were treated for truncal acne only in the LTE study, the unadjusted proportions achieving truncal IGA 0/1 were greater among patients previously treated with clascoterone vs vehicle in the pivotal studies at extension day 274 (46/126 [36.5%] vs 32/120 [26.7%], respectively; Figure 3).
