Clinical Evaluation of Safety and Efficacy of a New Topical Treatment for Onychomycosis

October 2011 | Volume 10 | Issue 10 | Original Article | 1186 | Copyright © 2011

Abstract

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. J Drugs Dermatol. 2011;10(10):1186-1191.

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INTRODUCTION

Onychomycosis, a condition in which fungi infect the nails, is a relatively common disease accounting for up to 50 percent of all nail disorders.1 Prevalence rises with age, due to diminished blood circulation, longer cumulative time of exposure to fungi, nail trauma, immune compromise such as diabetes and because nails may grow more slowly and thicken with aging, making them more susceptible to infection. This infection can cause changes in one or more nails such as brittleness, discoloration, loss of luster, thickening, distortion, crumbling, or detachment of the nail plate from the nail bed. Additional complications of onychomycosis can include pain, fissuring and secondary infection such as cellulitis.

The causative fungi (dermatophytes) live in warm, moist environments. They can invade the skin through small cuts in the skin or separations between the nail and nail bed. Infection with nail fungus occurs more often in feet than hands due to confinement in dark, warm, moist environments inside shoes, where fungi can thrive. In addition, the diminished blood circulation and reduced lymphatic drainage in the toes compared with the fingers make it harder for the immune system to detect and eliminate the infection. Nail fungus affects males more than females. Diabetes, psoriasis, and immune deficiency also may increase the risk of developing nail fungus.

Nail fungal infections can be painful and may cause permanent damage to nails. They may also lead to secondary skin infections and other serious infections that can spread beyond the feet. Thickened, discolored nails also may be caused by psoriasis, eczema, lichen planus and other diseases, and therefore accurate diagnosis is critical.

Fungal nail infections are diagnosed by taking a sample of the debris under the nail. The debris can be visualized mi-

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