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Efficacy and safety of topical terbinafine 10% solution (MOB-015) in the treatment of mild to moderate distal subungual onychomycosis: A randomized, multicenter, double-blind, vehicle-controlled phase 3 study

Journal of the American Academy of Dermatology Sep 05, 2020

Gupta AK, Surprenant MS, Kempers SE, et al. - Researchers conducted this multicenter, double-blind, phase III, North American study to test the safety and effectiveness and of topical terbinafine 10% solution (MOB-015) for the treatment of distal and lateral subungual onychomycosis. Participants with mild to moderate distal and lateral subungual onychomycosis including 20% to 60% of at least 1 great toenail were randomized to the once-daily application of MOB-015 or matching vehicle for 48 weeks. At week 52, the mycological cure rate was 69.9% and 27.7%, respectively, in the MOB-015 and vehicle groups, and a complete cure was obtained in 4.5% and 0% of patients, respectively. Overall, the authors concluded that MOB-015 is an onychomycosis treatment alternative with an adverse event profile similar to the vehicle.

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