Efficacy and safety of tavaborole topical solution, 5%, a novel boron-based antifungal agent, for the treatment of toenail onychomycosis: Results from 2 randomized phase-III studies.

BACKGROUND: Onychomycosis, a fungal nail infection, can impact quality of life. OBJECTIVE: We sought to evaluate the efficacy and safety of tavaborole topical solution, 5% for treatment of toenail onychomycosis. METHODS: In 2 phase-III trials, adults with distal subungual onychomycosis affecting 20% to 60% of a target great toenail were randomized 2:1 to tavaborole or vehicle once daily for 48 weeks. The primary end point was complete cure of the target great toenail (completely clear nail with negative mycology) at week 52. Secondary end points included completely or almost clear nail, negative mycology, completely or almost clear nail plus negative mycology, and safety. RESULTS: Rates of negative mycology (31.1%-35.9% vs 7.2%-12.2%) and complete cure (6.5% and 9.1% vs 0.5% and 1.5%) significantly favored tavaborole versus vehicle (P ≤ .001). Completely or almost clear nail rates also significantly favored tavaborole versus vehicle (26.1%-27.5% vs 9.3%-14.6%; P < .001). Rates of completely or almost clear nail plus negative mycology (15.3%-17.9% vs 1.5%-3.9%) were significantly greater for tavaborole versus vehicle (P < .001). Application-site reactions with tavaborole included exfoliation (2.7%), erythema (1.6%), and dermatitis (1.3%). LIMITATIONS: Duration of follow-up is a limitation. CONCLUSION: Tavaborole demonstrates a favorable benefit-risk profile in treatment of toenail onychomycosis.

Toenail assessment tool for quantitation of visibly infected mycotic nail plate in onychomycosis.

Typically, the amount of mycotic nail involvement in onychomycosis (fungal infection of the nail) before and after drug therapy is determined visually. Because there is an inherent element of subjectivity, it is difficult to accurately measure and compare results across clinical trials or to assess how much improvement has been achieved in response to therapy. We developed a simple tool for measuring mycotic nail involvement. This novel tool consists of a large grid containing 5 toenail templates of varying nail morphologies that are derived from the actual shape of the toenail of the great toe in several males and females, and one standardized computer-generated nail shape. The toenail templates are presented in 7 different sizes to match different nail sizes. Each toenail template is further divided into 8 segments, each comprising approximately 12.5% of the total nail surface. Measurement of the percentage of mycotic nail involvement is accomplished by the following procedure: (1) placing tracing film over the target toenail; (2) tracing the outline of the entire toenail, followed by tracing the affected portion of the toenail on the same film; (3) placing the tracing film over a nail template on the grid that best fits the shape of the toenail; and (4) counting the number of grid segments that correspond to 50% or more involvement. To assess feasibility, the tool was used in a large randomized trial involving over 30 sites and 500 subjects with onychomycosis. This tool is a more accurate and less biased alternative to visual assessment for measuring nail involvement or progression of nail clearing.