Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne: Two Phase 3 Randomized Clinical Trials

Data from the studies (n=1440) showed that use of a novel topical androgen receptor inhibitor, clascoterone cream, was associated with greater treatment success vs treatment with vehicle, with reductions in absolute non-inflammatory and inflammatory lesion counts.

SPS commentary:

At week 12, treatment success rates across the two studies were 18.4% (p<0 .001) and 20.3% (p<0 .001) vs 9.0% and 6.5% with vehicle, respectively


According to an editorial, because clascoterone is rapidly hydrolysed to cortexolone, there is the possibility for adrenal suppression. It notes that while no clinical symptoms of adrenal suppression were observed in a phase II study or the phase 3 trials, this potential adverse effect may be important to consider, particularly when using larger quantities of clascoterone.


It suggests that although clascoterone represents an exciting new therapeutic option for patients with acne, many questions remain. First, it will be important to identify where clascoterone fits in the therapeutic ladder for acne treatment, second whether there are specific subgroups for whom clascoterone cream is most effective, and lastly, whether it can help reduce reliance on oral antibiotics for the treatment of acne. It adds that as a novel class of topical acne treatment, clascoterone cream, 1%, may help patients for whom other topical treatments failed and may create opportunities for new combination approaches with greater efficacy, such as using it together with a topical retinoid.


JAMA Dermatology

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