Efinaconazole 10% Topical Solution: Treatment of Mild to Moderate Toenail Onychomycosis in Japanese Subjects

Abstract

Objective: To evaluate efficacy, safety, and tolerability of efinaconazole topical solution, 10% in a cohort of Japanese patients with mild to moderate toenail onychomycosis. Methods: A subgroup analysis of patients, aged 22-70 years, randomized to receive efinaconazole topical solution, 10% or vehicle from a multicenter, double-blind, vehicle-controlled 48-week study evaluating safety and efficacy. The primary end point was complete cure rate (0% clinical involvement of target toenail, and both negative potassium hydroxide examination and fungal culture) at Week 52. Results: The primary end point, complete cure, was achieved in 30.6% of patients treated with efinaconazole compared to 12.3% with vehicle (Observed case, P=.006), and was significantly better than that seen in the non-Japanese patients (P<.001). Treatment success (percent affected target toenail ≤10% at week 52) for efinaconazole was 60.6% compared to 33.3% with vehicle (P<.001). The majority of adverse events (AEs) were mild (16.6%) or moderate (81.1%) and few (7.8%) associated with efinaconazole. Eleven patients (6.0%) treated with efinaconazole discontinued the study due to AEs. Conclusions: Once daily efinaconazole topical solution, 10% may provide a useful topical option in the treatment of mild to moderate onychomycosis among ethnic Japanese patients.