Sequential Treatment with Laser Therapy and Nail Hydro-Lacquer Terbinafine in Comparison with Laser Treatment Alone in Onychomycosis: A Randomized Multicenter Prospective Assessor-Blinded Trial
Abstract
Background information: Onychomycosis is a prevalent and persistent fungal infection of the nails, primarily caused by Trichophyton rubrum, posing therapeutic challenges due to poor drug penetration and high relapse rates. While oral antifungals like terbinafine remain effective, topical alternatives and physical adjuncts such as laser therapy are being explored to enhance efficacy and safety. Objective: This randomized prospective assessor-blinded clinical trial aimed to evaluate the efficacy of combining 980 nm diode laser therapy with a terbinafine nail lacquier formulated in a hydro-alcoholic solution of hydroxy-propyl chitosan (Onicoter, Cantabria Labs Difa Cooper) compared to laser therapy alone in the treatment of mild-to-moderate onychomycosis. Methods: A total of 111 patients were randomized in a 1:2 ratio to receive either laser therapy alone (Group A, n=37) or laser therapy followed by topical terbinafine nail lacquer application (Group B, n=74). Laser treatment was administered weekly for three sessions, followed in Group B by daily lacquer application for four weeks and weekly thereafter for six months. Clinical parameters—nail involvement area, dyschromia, and dystrophy—were assessed at baseline (V0)
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 111 participants or records.
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