Integrated Short-Term and Long-Term Efficacy of Topical Clascoterone Cream 1% in Patients ≥12 years of Age With Acne Vulgaris

Abstract

Background: Clascoterone cream 1% is approved for the treatment of acne vulgaris in patients aged ≥12 years based on results from two identical pivotal Phase 3 trials. Integrated efficacy of clascoterone in patients aged ≥12 years with acne vulgaris from the pivotal trials (NCT02608450 and NCT02608476) and long-term extension (LTE) study (NCT02682264) is reported. Methods: In the pivotal trials, patients with moderate-to-severe Do Notacne Copy vulgaris were randomized 1:1 to twice-daily application of clascoterone cream 1% or vehicle for 12 weeks; they could Penalties then enter Apply the LTE study, where all patients applied clascoterone to the face and, if desired, trunk for up to 9 additional months. Efficacy was assessed from treatment success based on Investigator’s Global Assessment scores (IGA 0/1) in patients aged ≥12 years in the intention-to-treat population; lesion counts were assessed through week 12. Missing data were handled using multiple imputation in the pivotal studies and were not imputed in the LTE study. Results: Of 1421 patients enrolled, 1143 (clascoterone, 576; vehicle, 567) completed week 12; 600 entered and 343 completed the LTE study. The treatment success rate and most lesion count reductions following clascoterone vs placebo treatment reached statistical significance at week 12; the overall treatment success rate increased to 30.2% for facial acne after 12 months and 31.7% for truncal acne after 9 months of treatment. Conclusions: The efficacy of clascoterone cream 1% for the treatment of acne vulgaris continued to increase over time for up to 12 months in patients aged ≥12 years with acne vulgaris.