Topical creams containing 0.1%, 0.5%, and 1% clascoterone were safe, well tolerated, and more effective for reducing inflammatory and non-inflammatory lesions compared with vehicle control in patients with facial acne, according to a study published in the Journal of Drugs in Dermatology. Clascoterone is an androgen receptor inhibitor with a molecular structure containing a backbone identical to dihydrotestosterone, which is rapidly hydrolyzed to an inactive metabolite by both skin and plasma esterases.
Twice-daily topical creams containing 0.1% clascoterone (n=72) and 0.5% clascoterone (n=76) as well as daily 1% clascoterone (n=70) and twice-daily 1.0% clascoterone (n=70) were compared with vehicle control (daily or twice daily; n=75) in participants aged ≥12 years (mean age, 19.7 years) with facial acne vulgaris. The efficacy of the products was assessed by the Investigator’s Global Assessment, which examined change in the overall severity of acne on a 5-point scale (0=clear to 4=severe).
Additionally, the researchers examined inflammatory and noninflammatory acne lesion counts and subject satisfaction on a 4-point scale. Additional safety outcomes included local and systemic adverse events, physical examination/vital signs, laboratory test results, local skin reactions, and electrocardiogram results. A score of “clear” or “almost clear” as well as an at least 2 grade improvement in acne from baseline to week 12 defined treatment success.
At week 12, treatment success was greater for participants who received twice-daily 1% (8.6%) and twice-daily 0.1% (8.3%) clascoterone compared with participants who received vehicle control (2.7%). Relative to the control group, participants who received active treatments experienced significantly greater absolute changes in inflammatory lesions (P =.0431) and noninflammatory lesions (P =.0303).
Greater median changes were observed with the 1% twice-daily group in terms of inflammatory lesions (-13.5) and noninflammatory lesions (-17.5) from baseline to week 12. Treatment satisfaction at 12 weeks and at the end of the study were comparable among the 5 treatments, with the highest reported in the twice-daily 1% group (72.6%) compared with vehicle (64.2%) and twice-daily 0.5% (61.45). A total of 123 adverse events were observed, with only 3 of these considered severe in nature.
Limitations of the study include the relatively small sample size as well as the short duration of follow-up.
“Clascoterone cream represents the first potential topical androgen receptor inhibitor for the treatment of acne vulgaris,” the researchers wrote.
Disclosures: The authors disclosed financial interests with Cassiopea SpA, which funded the study.
Editor’s Note: This article was updated on July 19, 2019, to reflect changes to the headline and introductory paragraph.
Mazzetti A, Moro L, Gerloni M, Cartwright M. A phase 2b, randomized, double-blind vehicle controlled, dose escalation study evaluating clascoterone 0.1%, 0.5%, and 1% topical cream in subjects with facial acne. J Drugs Dermatol. 2019;18(6):570.