Safety
Topical 1% clascoterone cream maintained a favorable safety profile in patients 12 years of age and older. The incidence of TEAEs was similar between treatment arms. Most TEAEs were mild or moderate in severity; there were no serious TEAEs in patients treated with clascoterone, but 2 (0.3%) vehicletreated patients experienced serious TEAEs. The most frequent TEAEs in clascoterone-treated vs vehicle-treated patients were nasopharyngitis (1.4% vs 2.8%), headache (0.8% vs 0.6%), and oropharyngeal pain (0.8% vs 0.7%), respectively (Table 2). The majority of patients in each treatment group remained free of LSRs through week 12 (Table 3). The majority of LSRs observed were minimal or mild in severity, and the most frequent were erythema, scaling/dryness, and skin atrophy. The most frequent LSRs considered moderate in severity were pruritus and erythema, in 1.7% and 1.5% of vehicle-treated patients and in 1.1% and 0.8% clascoterone-treated patients, respectively. Pruritus was considered severe in only 0.4% of vehicle-treated and 0.3% of clascoterone-treated patients (Table 3).
