Findings from an open-label, long-term extension study show topical clascoterone cream 1% maintained a favourable safety and efficacy profile for up to 12 months in patients aged 12 years or older.
The paper was published in the Journal of Drugs in Dermatology.
In the study, the authors note that clascoterone cream 1% was approved in the U.S. for the treatment of acne vulgaris in patients aged 12 years or older based on results from two 12-week Phase 3 studies in patients with moderate-to-severe acne.
Of 600 patients initially enrolled, 343 completed the extension study (177 treated with clascoterone cream 1%, twice daily for nine months, 166 vehicle controls). The participants applied either the active or control cream to their entire face and, if desired by the patient or an investigator, to truncal acne. Any participant who achieved an Investigator’s Global Assessment (IGA) score of clear or almost clear (IGA 0 or 1) had the option to stop treatment and resume if or when their acne worsened.
During the study, there were 187 treatment-related adverse events in 108 of 598 clascoterone treated patients (18.1%), including 56 of 311 (18.0%) and 52 of 287 (18.1%) patients originally randomized to clascoterone and vehicle, respectively. The most common local skin reactions were erythema and scaling or dryness. The percentage of patients who completed treatment per protocol with facial and truncal IGA scores of 0/1 increased to 48.9% (156/319) and 52.4% (65/124), respectively, at the study end.
In their conclusions, the authors write that the findings suggest that clascoterone cream 1% “may be a safe and effective alternative to traditional acne medications for long-term treatment.”