Efficacy and Safety of 1% Clascoterone Cream in Patients Aged > 12 Years With Acne Vulgaris

J Drugs Dermatol. 2023 Feb 1;22(2):174-181. doi: 10.36849/JDD.7000.


Background: Two randomized phase 3 studies evaluated efficacy and safety of 1% clascoterone cream, a topical androgen receptor inhibitor, in patients aged ≥9 years with moderate-to-severe facial acne vulgaris after 12 weeks of treatment.

Objectives: To present a pooled data analysis of the efficacy and safety of 1% clascoterone cream after 12 weeks of treatment in patients aged ≥12 years from the 2 phase 3 trials.

Methods: Patients were randomized 1:1 to twice-daily treatment of the whole face with clascoterone or vehicle. Primary efficacy outcomes were proportion of patients achieving treatment success (Investigator Global Assessment score of "clear" [0] or "almost clear" [1] with ≥2-point reduction from baseline) and absolute change from baseline (CFB) in noninflammatory lesion count and inflammatory lesion count; secondary efficacy outcomes included absolute CFB in total lesion count at week 12. Safety was assessed from treatment-emergent adverse events and local skin reactions.

Results: 709/712 patients age ≥12 years were treated with clascoterone/vehicle. After 12 weeks, clascoterone was efficacious compared with vehicle, based on proportion of patients achieving treatment success (19.9% vs 7.7%) and CFB in noninflammatory lesion count (-20.8 vs -11.9), inflammatory lesion count (-19.7 vs -14.0), and total lesion count (-40.0 vs -26.1; all P<0.0001). Frequencies of local skin reactions were low and similar between treatment arms, with no new safety signals.

Conclusions: Clascoterone is efficacious, with a favorable safety profile and low rates of local skin reactions in patients ≥12 years of age with facial acne vulgaris. (Clinicaltrials.gov NCT02608450 and NCT02608476) J Drugs Dermatol. 2023;22(2): doi:10.36849/JDD.7000.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Acne Vulgaris* / diagnosis
  • Acne Vulgaris* / drug therapy
  • Acne Vulgaris* / etiology
  • Child
  • Double-Blind Method
  • Emollients / therapeutic use
  • Humans
  • Propionates* / therapeutic use
  • Severity of Illness Index
  • Skin Cream* / therapeutic use
  • Treatment Outcome


  • Clascoterone
  • Emollients
  • Propionates

Associated data

  • ClinicalTrials.gov/NCT02608450
  • ClinicalTrials.gov/NCT02608476