Clascoterone Cream Efficacious and Safe in Patients With Facial Acne Vulgaris

Among patients 12 years of age and older with facial acne vulgaris, 1% clascoterone cream was found to be efficacious and has a favorable safety profile, according to the results of a pooled analysis published in the Journal of Drugs in Dermatology.

According to the study authors, “Topical 1% clascoterone cream (cortexolone 17α-propionate) is an androgen receptor inhibitor indicated for the topical treatment of acne in patients 12 years and older and is the first topical androgen receptor inhibitor approved by the US Food and Drug Administration (FDA) for acne treatment.”

Investigators presented pooled data on the efficacy and safety of 1% clascoterone cream after 12 weeks of treatment in patients 12 years of age and older. Primary efficacy endpoints were absolute change from baseline in noninflammatory lesion count and inflammatory lesion count, and the proportion of patients achieving an Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline (treatment success). Primary safety endpoints were treatment-emergent adverse events and local skin reactions.

Researchers conducted a review of data from 2 phase 3 multicenter, double-blind, randomized controlled studies (ClinicalTrials.gov Identifiers: NCT02608450 and NCT02608476) conducted between January 2016 and April 2018, and from November 2015 to February 2018, respectively. The study population included male or female patients aged 9 years and older with facial acne vulgaris and an IGA score of 3 or 4 (4=severe); pregnant patients were excluded from the study.

A total of 722 patients were randomly assigned to twice-daily treatment of the whole face with 1% clascoterone cream and 718 patients were treated with vehicle. In the current analysis, only patients 12 years of age and older were included (n=709 treated with 1% clascoterone cream, 63.9% girls/women; n=712 treated with vehicle, 60.4% girls/women). Patients with more than 2 facial nodules, nodulocystic acne, or any skin pathology or condition that might interfere with the study were excluded. Exclusion criteria also included the use of topical or systemic anti-acne treatments within 2 to 4 weeks of treatment initiation and use of spironolactone within 8 weeks of treatment initiation.

Characteristics of the clascoterone and vehicle groups were balanced.  Most patients were White (91.0% vs 90.3%), with a mean age of 19.8 years and 19.5 years, respectively. An IGA score of 3 (moderate) was reported for 82.5% and 84.1%, and an IGA score of 4 (severe) was reported for 17.5% and 15.9%, respectively. The majority of patients in both arms had Fitzpatrick skin type II or III.

Assessment was performed 12 weeks. Compared with vehicle, treatment with clascoterone was found to be efficacious based on the proportion of patients achieving treatment success (19.9% vs 7.7%) and change from baseline in inflammatory lesion count (-19.7 vs -14.0), noninflammatory lesion count (-20.8 vs -11.9), and total lesion count (-40.0 vs -26.1; all P <.0001).

Frequencies of local skin reactions were similar between treatment arms and low. The most frequent mild local skin reactions were erythema, scaling/dryness, and skin atrophy. The most frequent moderate local skin reactions in the clascoterone group were pruritus (1.1%) and erythema (0.8%). Severe pruritus was reported by 0.3% of patients in the clascoterone group.

At least 1 treatment-emergent adverse event was reported by 11.1% of patients in the clascoterone group through week 12, all of which were moderate or mild and the most frequent of which were nasopharyngitis, headache, and oropharyngeal pain. Discontinuation of treatment was required for 5 patients in the clascoterone group due to treatment-emergent adverse events.

Study limitations include the exclusion of patients who were using other acne medications, as well as the lack of assessment of the treatment’s impact on quality of life.

Study authors conclude, “Clascoterone is efficacious, with a favorable safety profile and low rates of local skin reactions in patients ≥12 years of age with facial acne vulgaris.” They comment that “[f]urther studies are needed to investigate the efficacy and safety of 1% clascoterone cream in combination with other topical acne medications.”

Disclosure: This research was supported by Cassiopea S.p.A. and Sun Pharmaceutical Industries, Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.