Efinaconazole 10% Proven Safe and Effective for Toenail Fungus in Older Adults: Study

Onychomycosis, a fungal toenail infection, is particularly common in the elderly. Thicker nails and slower growth, both associated with aging, as well as comorbid medical conditions, contribute to making the infection more difficult to treat. Oral antifungals, while effective, carry risks including liver injury and drug–drug interactions that are particularly problematic in this age category. Topical treatments such as efinaconazole 10% solution, which can be applied locally to the nail with minimal absorption into the body, provide a safer option. Hitherto, there have been sparse data on their efficacy particularly among elderly populations.

This analysis employed data from two multicenter, randomized, double-blind, vehicle-controlled phase 3 trials (NCT01008033 and NCT01007708), involving once-daily use of efinaconazole 10% solution or vehicle for 48 weeks with a post-treatment follow-up period of 4 weeks. The analysis was applied to a subgroup of patients 65 years of age or older, with mild to moderate toenail onychomycosis, consisting of 162 patients who received efinaconazole and 56 patients treated with vehicle. The main outcome was 52-week complete cure, which was taken as 0% clinical involvement of the target toenail and mycologic cure (negative potassium hydroxide [KOH] microscopy and fungal culture). Secondary outcomes were mycologic cure and complete or near complete cure (≤5% nail involvement + mycologic cure). Safety was evaluated through treatment-emergent adverse events (TEAEs).