Clinical evaluation of safety and efficacy of a new topical treatment for onychomycosis.

OBJECTIVE: This clinical study assessed the safety and efficacy of an investigational topical product for the treatment of onychomycosis (nail fungus). METHOD: A prospective, multi-center, single-arm, self-controlled clinical investigation was done with adult subjects that met the inclusion criteria, primarily culture-confirmed dermatophyte infection of at least one great toe. Subjects self-treated in a weekly regimen of topical application for six months, with clinical assessment at one, three, and six months. Primary efficacy endpoint was clearance of fungal nail infection after six months of weekly treatment. Primary safety endpoint was freedom from product-related adverse events for the duration of the treatment term. RESULTS: Fifty males and 13 females, ages 24 to 65, infected with Trichophyton (n=62) or Epidermophyton (n=1) were enrolled; 53 completed six months of assessment. Sixty percent showed improvement in clinical parameters (nail color, nail plate involvement, onycholysis, thickness, and hyperkeratosis) at six months. Cumulative rates of dermatophyte-negative culture results (test of cure) were 28, 36, and 62 percent of subjects after one, three, and six months of treatment, respectively. Three minor adverse events were device-related, with no unanticipated or serious adverse events. LIMITATIONS: This study was single-arm and self-controlled; 53 of 63 enrolled subjects completed the study. CONCLUSION: This study describes a new topical medical device with safety and efficacy profiles that compare favorably to results reported for topically applied onychomycosis drug treatments.