Adelaide Hebert, M.D., from the University of Texas Health Science Center in Houston, and colleagues assessed the safety and efficacy of clascoterone cream, 1 percent, a novel topical androgen receptor inhibitor, in two phase 3 clinical trials (including a total 1,440 patients) in which patients were randomly assigned to clascoterone cream, 1 percent, or a vehicle cream.

The researchers found that at week 12, the treatment success rates with clascoterone cream were 18.4 and 20.3 percent versus 9 and 6.5 percent with vehicle creams, respectively. In both intervention groups at week 12, there was a significant reduction in absolute noninflammatory lesions from baseline to −19.4 versus −13 and −10.8 with the vehicle cream, respectively. Similarly, there was a reduction in inflammatory lesions from baseline in the two intervention groups of −19.3 and −20 versus −15.5 and −12.6 with vehicle cream, respectively. The predominant adverse reaction was trace or mild erythema, but rates were low.

“Clascoterone cream, 1 percent, is under consideration as a first-in-class therapeutic agent for acne treatment, potentially providing an alternative to antibiotics and/or offering an adjunct treatment to existing combination acne therapies, including retinoids,” the authors write.

Several authors disclosed financial ties to pharmaceutical companies, including Cassiopea, which manufactures clascoterone and funded the study.