A multicentre, randomised, parallel-group, double-blind, vehicle-controlled and open-label, active-controlled study (versus amorolfine 5%), to evaluate the efficacy and safety of terbinafine 10% nail lacquer in the treatment of onychomycosis.

Abstract

Onychomycosis is a difficult-to-treat fungal nail infection whose treatment can involve systemic or topical antifungal approaches. To assess the efficacy and safety of terbinafine 10% nail lacquer in distal-lateral subungual onychomycosis (DLSO). Patients with mild-to-moderate DLSO were randomised (3:3:1) to receive double-blind topical terbinafine 10% (n=406) or its vehicle (n=410) administered once daily for 4weeks and then once weekly for 44weeks, or open-label topical amorolfine 5% (n=137) for 48weeks, with a 12-week follow-up period. The primary efficacy endpoint, complete cure rate at Week 60, was a composite of negative potassium hydroxide (KOH) microscopy, negative culture for dermatophytes and no residual clinical involvement of the target big toenail. Complete cure rates at Week 60 in the terbinafine, vehicle and amorolfine groups were 5.67%, 2.20% and 2.92%, respectively (odds ratio (OR) vs vehicle=2.68; 95% confidence intervals (CI): 1.22-5.86; p=.0138). Statistically significant differences in responder (negative KOH and negative culture and ≤10% residual clinical involvement) and mycological cure rates (negative KOH and negative culture) at Week 60 were obtained between terbinafine and vehicle. Terbinafine was well-tolerated with no systemic adverse reactions identified; the most common topical adverse reactions were erythema and skin irritation. Terbinafine 10% nail lacquer was an effective treatment for mild-to-moderate onychomycosis improving both clinical and mycological criteria compared with vehicle. Furthermore, there may be some benefits compared to the currently available topical agent, amorolfine 5%. Treatment was well-tolerated and safe.