TUESDAY, Aug. 22, 2023  -- For patients aged 12 years and older with moderate-to-severe acne, clascoterone cream 1 percent has favorable long-term safety and efficacy, according to a study published in the August issue of the Journal of Drugs in Dermatology.

Lawrence F. Eichenfield, M.D., from the University of California San Diego School of Medicine in La Jolla, and colleagues examined the safety and efficacy of clascoterone in patients aged 12 years and older with moderate-to-severe acne from an open-label, long-term extension study. Enrolled patients applied clascoterone cream 1 percent twice daily to the entire face and/or truncal area for up to nine months. Of 600 patients (311 originally randomly assigned to clascoterone; 289 to vehicle), 343 (177 clascoterone; 166 vehicle) completed the extension study.

The researchers found that 187 treatment-emergent adverse events occurred in 18.1 percent of all clascoterone-treated patients, including 18.0 and 18.1 percent originally randomly assigned to clascoterone and vehicle, respectively. The most common local skin reactions were erythema (face, 8.0 and 7.7 percent; trunk, 6.1 and 7.3 percent) and scaling/dryness (face, 10.0 and 7.3 percent; trunk, 3.5 and 4.5 percent) for patients originally randomly assigned to clascoterone and vehicle, respectively. At study end, the percentage of per-protocol patients with facial and truncal Investigator's Global Assessment Score of 0 or 1 increased to 48.9 and 52.4 percent, respectively.

"The findings from this and previous studies support clascoterone as an option for long-term treatment of acne vulgaris," the authors write.

Several authors disclosed ties to the pharmaceutical industry, including Cassiopea S.p.A., which funded the study.