Integrated Short-Term and Long-Term Efficacy of Topical Clascoterone Cream 1% in Patients Aged 12 Years or Older With Acne Vulgaris

January 2024 | Volume 23 | Issue 1 | 1278 | Copyright © January 2024


Published online December 12, 2023

doi:10.36849/JDD.7719

Lawrence F. Eichenfield MDa, Linda Stein Gold MDb, Jenny Han MSc, Adelaide A. Hebert MDd, Alessandro Mazzetti MDe, Luigi Moro PhDe, Nicholas Squittieri MDf, Diane Thiboutot MDg

aDepartments of Dermatology and Pediatrics, University of California San Diego and Rady Children’s Hospital-San Diego, San Diego, CA
bDepartment of Dermatology, Henry Ford Medical Center, Detroit, MI
cPharmapace, Inc., San Diego, CA
dDepartment of Dermatology, UTHealth McGovern Medical School, Houston, TX
eCassiopea S.P.A., Lainate, Italy
fSun Pharmaceutical Industries, Inc., Princeton, NJ 
gDepartment of Dermatology, The Pennsylvania State University College of Medicine, Hershey, PA

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.
 
J Drugs Dermatol. 2024;23(1):1278-1283.     doi:10.36849/JDD.7719

INTRODUCTION

Acne vulgaris is the eighth most prevalent disease worldwide, affecting approximately 85% of adolescents and young adults aged 12 to 25 years.1,2 Androgen inhibition is an effective strategy for treating acne in female patients.3 However, treatment with systemic androgen inhibitors such as combined oral contraceptives and spironolactone is associated with side effects that restrict their use in male patients, pregnancy, and other high-risk conditions.4 

Clascoterone is a first-in-class molecule that competitively binds to androgen receptors with high affinity and inhibits the transcription of androgen-responsive genes, including sebum components and inflammatory cytokines.5 Clascoterone cream 1% is approved in the US for the treatment of acne vulgaris in patients aged 12 years or older.6 In two identical pivotal Phase 3 trials in patients with facial acne vulgaris, treatment with clascoterone cream 1% resulted in a marked clinical improvement after 12 weeks, with a favorable safety profile during up to 12 months of treatment in the extension study; efficacy was also maintained in patients who completed the extension study per protocol.3,7-9 Here, we present the integrated efficacy of clascoterone cream 1% in the intention-to-treat (ITT) population of patients aged 12 years or older with acne vulgaris in the pivotal and extension studies.
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