Integrated Short-Term and Long-Term Efficacy of Topical Clascoterone Cream 1% in Patients Aged 12 Years or Older With Acne Vulgaris
Recommended Citation
Eichenfield LF, Gold LS, Han J, Hebert AA, Mazzetti A, Moro L, Squittieri N, and Thiboutot D. Integrated Short-Term and Long-Term Efficacy of Topical Clascoterone Cream 1% in Patients Aged 12 Years or Older With Acne Vulgaris. J Drugs Dermatol 2024; 23(1):1278-1283.
Document Type
Article
Publication Date
1-1-2024
Publication Title
Journal of drugs in dermatology
Abstract
BACKGROUND: Clascoterone cream 1% is approved for the treatment of acne vulgaris in patients aged 12 years or older based on results from two identical pivotal Phase 3 trials. Integrated efficacy of clascoterone in patients aged 12 years or older 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 acne vulgaris were randomized 1:1 to twice-daily application of clascoterone cream 1% or vehicle for 12 weeks; they could then enter 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 or older 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 or older with acne vulgaris.
Medical Subject Headings
Humans; Acne Vulgaris; Cortodoxone; Emollients; Plastic Surgery Procedures; Propionates
PubMed ID
38206145
ePublication
ePub ahead of print
Volume
23
Issue
1
First Page
1278
Last Page
1283
