Efficacy
The percentage of PP patients who achieved facial IGA 0/1 (clear or almost clear) increased over time from 43/319 (13.5%) at baseline to 156/319 (48.9%) at the end of the study (9 months of treatment), with improvement observed at most visits (Figure 3). The percentage of patients with facial IGA 0/1 was higher at baseline in patients previously treated with clascoterone (30/167 [18.0%]) vs vehicle (13/152 [8.6%]) and increased over time in both cohorts to 84/167 (50.3%) and 72/152 (47.4%), respectively, at the end of the study.
For truncal acne, the percentage of PP patients with truncal IGA 0/1 at baseline was low overall (5/124 [4.0%]) and increased to 65/124 [52.4%]) at the end of the study, with improvement observed at each visit (Figure 4). The percentage of patients with truncal IGA 0/1 generally increased over time regardless of prior exposure to facial clascoterone treatment, although the greatest percentage was observed at the end of the study in patients originally randomized to clascoterone (41/67 [61.2%]).
Among the original study population of patients greater than or equal to 9 years of age, the proportion of PP patients with clear or almost clear skin on the face and trunk at the end of the study was comparable to that observed in the subgroup of patients greater than or equal to 12 years old (facial IGA 0/1, 156/324 [48.1%]; truncal IGA 0/1, 66/126 [52.3%] for patients greater than or equal to 9 years old).
For truncal acne, the percentage of PP patients with truncal IGA 0/1 at baseline was low overall (5/124 [4.0%]) and increased to 65/124 [52.4%]) at the end of the study, with improvement observed at each visit (Figure 4). The percentage of patients with truncal IGA 0/1 generally increased over time regardless of prior exposure to facial clascoterone treatment, although the greatest percentage was observed at the end of the study in patients originally randomized to clascoterone (41/67 [61.2%]).
Among the original study population of patients greater than or equal to 9 years of age, the proportion of PP patients with clear or almost clear skin on the face and trunk at the end of the study was comparable to that observed in the subgroup of patients greater than or equal to 12 years old (facial IGA 0/1, 156/324 [48.1%]; truncal IGA 0/1, 66/126 [52.3%] for patients greater than or equal to 9 years old).
DISCUSSION
This 9-month extension study confirmed the favorable safety profile of clascoterone cream 1% in the long-term treatment of patients greater than or equal to 12 years of age with moderate-to-severe facial and/or truncal acne vulgaris. The frequencies of TEAEs and LSRs were low throughout the study; most reported TEAEs were mild in severity, and there was no accumulation of AEs observed over time. The proportions of patients with facial and truncal IGA 0/1 increased over time and were highest at the end of the study, indicating that clascoterone efficacy continued to increase with long-term treatment. These results suggest that clascoterone
