A Randomized, Double-Blind, Controlled Trial Evaluating the Efficacy of Nd:YAG 1064 nm Short-Pulse Laser Compared With Placebo in the Treatment of Toenail Onychomycosis.

Laser and light-based therapies have emerged as interesting treatment options with minimal side effects or contraindications to treat onychomycosis. Although increasing reports of successful treatment exist, few randomized, controlled, prospective studies have evaluated their true efficacy. We conducted a prospective, randomized, double-blind, controlled trial to evaluate the cure rate of onychomycosis treated by laser. Fifty-one patients were randomized to receive 3 treatments (0, 12, 24 weeks) of 1064 Nd:YAG short-pulse (Cutera GenesisPlus) laser or placebo sham laser. The primary efficacy end point is the proportion of patients with a complete cure rate of the target great toenail at week 52. The secondary efficacy end points, at week 52, were treatment success defined as almost clear nail (≤ 10%) and negative mycology, completely or almost clear nail of the great toenail, negative mycology, improvement from one OSI severity class to another of the target toenail, and the difference in proximal nail plate clearance between baseline and week 52. No patient (0%) in the laser group and 2 patients (7.7%) in the placebo group reached the primary outcome. One patient (4.8%) in the laser group reached treatment success vs 2 (7.7%) in the placebo group. Only 6 patients (33%) had negative cultures in the laser group vs 11 (50%) in the placebo group. None of the secondary end points were met. This study demonstrated that 3 treatments of Nd:YAG 1064 nm laser at 3-month intervals were not effective to treat onychomycosis.