For patients with mild-to-moderate distal and lateral subungual onychomycosis, topical terbinafine 10 percent solution (MOB-015) is effective, with an adverse event profile similar to vehicle, according to a study published in the July issue of the Journal of the American Academy of Dermatology.

Aditya K. Gupta, M.D., from the University of Toronto, and colleagues examined the efficacy and safety of MOB-015 for the treatment of distal and lateral subungual onychomycosis in a multicenter, double-blind study. Participants with mild-to-moderate distal and lateral subungual onychomycosis involving 20 to 60 percent of at least one great toenail were randomly assigned to MOB-015 (246 patients) or matching vehicle (119 patients) once daily for 48 weeks.

The researchers found that the mycological cure rate (negative culture and potassium hydroxide microscopy) was 69.9 and 27.7 percent in the MOB-015 and vehicle groups, respectively, at week 52. Complete cure (0 percent clinical disease involvement and mycological cure) was achieved in 4.5 and 0 percent of patients, respectively. In 2.8 and 4.2 percent of patients in the MOB-015 and vehicle groups, respectively, at least one adverse event leading to discontinuation of treatment occurred.

"MOB-015 was significantly more effective in treating dermatophyte toe onychomycosis than vehicle, demonstrating a mycological cure rate of 69.9 percent without systemic adverse reactions or drug interactions that are associated with the oral formulation," the authors write.

Several authors disclosed financial ties to pharmaceutical companies, including Moberg, which manufactures MOB-015 and funded the study.

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