Topical terbinafine effective against mild-to-moderate onychomycosis

Topical terbinafine 10% solution (MOB-015) is a viable option for the treatment of mild-to-moderate distal subungual onychomycosis, with an adverse event profile similar to vehicle, suggests a study.

This randomized, multicentre, double-blind, vehicle-controlled phase III trial was conducted to assess the efficacy and safety of MOB-015 for the treatment of distal and lateral subungual onychomycosis. Patients with mild-to-moderate onychomycosis involving 20–60 percent of at least one great toenail were randomly assigned to once-daily application of MOB-015 or matching vehicle for 48 weeks.

Complete cure was the primary efficacy variable, while secondary ones were mycological cure and treatment success. Safety profiles were also evaluated.

The mycological cure (negative culture and potassium hydroxide microscopy) rate at week 52 was 69.9 percent in the MOB-015 group and 27.7 percent in the vehicle group (p<0.001); complete cure (0-percent clinical disease involvement and mycological cure) was achieved in 4.5 percent of patients in the MOB-015 arm and by none (0 percent) in the vehicle arm (p=0.0195).

At least one adverse event leading to treatment discontinuation occurred in 2.8 percent and 4.2 percent of patients in the MOB-015 and vehicle groups, respectively.

However, this study was limited by the seemingly short follow-up period after the end of treatment, which may not be enough to accurately reflect cure in distal and lateral subungual onychomycosis.

“Onychomycosis is a recalcitrant fungal nail infection,” the authors said. “Topical antifungal agents may be preferred over systemic agents due to lack of systemic adverse effects.”