42299 Long-term safety and efficacy of 1% clascoterone cream in patients <12 years old with acne vulgaris
Recommended Citation
Eichenfield LF, Hebert AA, Stein Gold LF, Cartwright M, Moro L, Han J, Squittieri N, Mazzetti A. 42299 Long-term safety and efficacy of 1% clascoterone cream in patients <12 years old with acne>vulgaris. J Am Acad Dermatol 2023; 89(3):AB190.
Document Type
Conference Proceeding
Publication Date
9-19-2023
Publication Title
J Am Acad Dermatol
Keywords
clascoterone, acne vulgaris, burn, child, clinical trial, conference abstract, controlled study, drug efficacy, drug safety, drug therapy, edema, erythema, face, female, human, local skin reaction, major clinical study, male, phase 3 clinical trial, preschool child, pruritus, skin atrophy, telangiectasia
Abstract
Background: Clascoterone cream 1% is approved for the treatment of acne vulgaris in patients aged 2:12 years based on results in two 12-week, vehicle-controlled, phase 3 studies in patients with moderate-to-severe acne. Long-term safety and efficacy of clascoterone in patients aged 2:12 years from the extension study [1] are presented. Methods: All patients who continued into the open-label, long-term extension study (NCT02682264) applied clascoterone twice daily to the entire face and, if desired, any truncal acne, for up to 9 months. Patients achieving Investigator’s Global Assessment score of 0 or 1 (IGA 0/1) could stop treatment and resume if/when acne worsened. Safety was assessed from treatment-emergent adverse events (TEAEs) and local skin reactions (LSRs [telangiectasia, skin atrophy, striae rubrae, erythema, edema, scaling/dryness, stinging/burning, and pruritus]) in all treated patients. Efficacy was assessed from percentage of patients with IGA 0/1 among those who completed the extension study without significant protocol deviations (per-protocol [PP] population). Results: Of 598 patients treated in the extension study, 108 (18.1%) experienced 187 TEAEs, with similar frequency between patients previously treated with vehicle (52/287 [18.1%]) vs clascoterone (56/311 [18.0%]). Frequency of LSRs was low throughout the study. Percentage of PP patients with facial and truncal IGA 0/1 increased over time to 48.9% (156/319) and 52.4% (65/124), respectively, at end of study and was greatest in patients applying clascoterone for 12 months (face, 67/119 [56.3%]). Conclusions: Clascoterone cream 1% maintained a favorable safety and efficacy profile for up to 12 months in patients aged 2:12 years.
Volume
89
Issue
3
First Page
AB190
