Patient disposition is shown in Figure 2. A total of 134 and 123 patients originally treated with clascoterone and vehicle, respectively, discontinued the study, most frequently because of patient withdrawal (55 [17.7%] and 46 [15.9%]) and loss to follow-up (49 [15.8%] and 41 [14.2%]). Overall, 245 patients in the safety population (126 originally randomized to clascoterone and 119 to vehicle) and 124 patients in the PP population (67 originally randomized to clascoterone and 57 to vehicle) treated truncal acne.
Treatment Exposure
During the extension study period, 184/598 (30.8%) patients in the safety population were treated with clascoterone for facial acne for up to 3 months, 85/598 (14.2%) for 3 to 6 months, 176/598 (29.4%) for 6 to 9 months, and 153/598 (25.6%) for greater than or equal to 9 months. Among patients treated with clascoterone for truncal acne, 70/245 (28.6%) were treated for up to 3 months, 31/245 (12.7%) for 3 to 6 months, 74/245 (30.2%) for 6 to 9 months, and 70/245 (28.6%) for greater than or equal to 9 months. The amount of cream applied daily and total duration of exposure to clascoterone in the extension study were similar among patients previously treated with clascoterone vs vehicle in the pivotal studies. Patients originally randomized to clascoterone in the pivotal studies had 3 months of treatment with clascoterone for facial acne prior to entering the extension study.
Safety
Overall, 108/598 (18.1%) patients in the safety population experienced a total of 187 TEAEs, with similar frequency between patients previously treated with clascoterone (56/311 [18.0%]) vs vehicle (52/287 [18.1%]; Table 2). The majority of reported TEAEs were mild or moderate in severity, and most were not considered related to clascoterone treatment. A total of 6/598 (1.0%) patients reported SAEs, none of which was considered related to clascoterone treatment, and 9/598 (1.5%) patients had TEAEs leading to study discontinuation. The most frequent TEAEs by percentage of patients affected included nasopharyngitis (17 [2.8%]), upper respiratory tract infection (11 [1.8%]), sinusitis (5 [0.8%]), viral respiratory tract infection (5 [0.8%]), and application site acne (4 [0.7%]) among all patients; TEAE frequencies were similar among patients originally randomized to clascoterone compared with vehicle in the pivotal Phase 3 studies (Table 3). No deaths were reported during the study.
The frequency of LSRs was low throughout the study in patients previously treated with either clascoterone or vehicle. The most common new or worsening LSRs in patients previously treated with clascoterone/vehicle were scaling/dryness (face, 10.0%/7.3%; trunk, 3.5%/4.5%) and erythema (face, 8.0%/7.7%; trunk, 6.1%/7.3%; Table 4).
