Is There a Clinically Relevant Risk of Hyperkalemia with Topical Clascoterone Treatment?

Clascoterone cream 1% is an androgen receptor inhibitor approved for the treatment of acne vulgaris in patients aged 12 years or older with clinical studies completed in subjects aged nine years or older. Blood potassium levels above the upper limit of normal (i.e., hyperkalemia) were reported in both clascoterone-treated and vehicle-treated patients; reported rates of hyperkalemia were approximately five percent and four percent, respectively. None of the cases of hyperkalemia were reported as adverse events and none led to study discontinuation or adverse clinical sequelae. An exposure-response analysis showed no correlation between plasma concentrations of clascoterone or its metabolite cortexolone and cases of hyperkalemia. Based on the laboratory safety profile of clascoterone demonstrated in the Phase I and Phase II studies, baseline or subsequent laboratory monitoring was not required in the Phase III studies or recommended in the FDA-approved prescribing information. The frequency of shifts to elevated potassium levels was highest in patients younger than 12 years of age treated with clascoterone, for whom clascoterone 1% is not FDA approved.