Amorolfine nail lacquer 5% once weekly in onychomycosis of fingers and/or toes

Background: Amorolfine is a new topical antifungal drug of the morpholine class which has broad spectrum fungicidal activity. Amorolfine nail lacquer 5% is a transungual delivery system which can penetrate well through the nail plate to the infected keratin and remain there for a prolonged period. Objective: The aim of this study is to assess the efficacy and tolerability of 5% amerolfine nail lacquer given once weekly to the patients with onychomycosis. Methods: 29 patients with onychomycosis affecting not more than 80% of the surface of nail were treated once weekly for up to 9 months with amorolfine nail lacquer 5%. Clinical and mycological examination were performed before treatment and 3, 6, 9 months after start of treatment. Final evaluation was done 3 months after the end of treatment. Results: Average affected area (%) and average score of clinical signs - thickening, splitting, discoloration - were significantly decreased 3 months after start of treatment. Mycological cure rate was continuously increased according to the treatment duration reaching 75.9% at 3 months after treatment. Overall efficacy assessed by the investgators were cure in 31.0% and improvement in 41.4%. Tolerability, mode and frequency of treatment, and formulation were evaluated as good or excellent by most of the patients. No systemic or local side effect was observed. Conclusion: Amorolfine nail lacquer 5% used once weekly up to 9 months was relatively effective and safe for the treatment of onychomycosis.