Diode Laser and Red‐Laser Photodynamic Therapy Versus Ciclopirox 8% <scp>HPCH</scp> Nail Lacquer for the Treatment of Onychomycosis: A Randomised Controlled Trial

Mycoses
Open Access

Clinical Summary

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What was studied

A randomized, parallel-group trial of 26 adults with PCR/culture‑confirmed toenail onychomycosis compared eight sessions of diode laser (810/1064 nm) plus red‑laser photodynamic therapy (635 nm, toluidine blue) over 9 weeks versus daily ciclopirox 8% HPCH nail lacquer for at least 9 months, with 12‑month follow‑up.

Key findings

Clinical cure per nail was 94.1% with laser+PDT (16/17) vs 53.3% with ciclopirox (8/15) (p=0.008; OR 0.071, 95% CI 0.007–0.685); all clinically cured nails achieved mycologic and complete cure (100%). Time to healing was shorter with laser+PDT (3.6±1.2 vs 9.2±1.6 months; p<0.001); adverse events occurred in 11.4% of treated nails (all laser+PDT; subungual hematoma/blisters) and recurrences occurred in 6/24 cured nails (33.3% of laser+PDT patients), with none in the ciclopirox group.

Study limitations

Small, single-center, open-label study with all procedures performed by one podiatrist. Microbiologic cultures were only repeated in clinically cured nails, which may overstate mycologic cure. Post‑treatment observation time and visit intensity differed between groups, potentially affecting recurrence and adherence.

Clinical implications

For adults who cannot take oral antifungals, an 8‑session diode laser plus red‑laser PDT protocol achieved higher clinical cure and faster healing than daily ciclopirox 8% HPCH, but with mild local adverse events and more recurrences in this small RCT. Consider selectively, pending confirmation in larger, blinded, multicenter trials.