Diode Laser and Red-Laser Photodynamic Therapy Versus Ciclopirox 8% HPCH Nail Lacquer for the Treatment of Onychomycosis: A Randomised Controlled Trial.

BACKGROUND

Antifungals are the standard treatment for onychomycosis. However, oral antifungals present contraindications and potential drug-drug interactions, while topical antifungals suffer from limited efficacy and penetration. Recently, researchers have explored physical therapies, including laser and photodynamic therapy.

OBJECTIVE

To evaluate the clinical efficacy of combining diode laser therapy with photodynamic therapy and ciclopirox 8% hydroxypropyl chitosan (HPCH) nail lacquer in treating onychomycosis.

METHODS

We conducted a randomised controlled clinical trial involving patients with onychomycosis. A total of 26 patients were enrolled and followed for 12 months. Participants received either eight sessions of laser treatment combined with three sessions of photodynamic therapy, or daily treatment with ciclopirox 8% HPCH.

RESULTS

The clinical cure rate was 94.1% in the group treated with laser and photodynamic therapy, compared to 53.3% in the group treated with ciclopirox 8% HPCH (p = 0.008). All patients who achieved clinical cure with either treatment also reached mycologic and complete cure, with a rate of 100%. The average time to healing was significantly shorter for the group receiving laser and photodynamic therapy (3.6 ± 1.2 months) than for those treated with ciclopirox 8% HPCH nail lacquer (9.2 ± 1.6 months) (p < 0.001). In the laser and photodynamic therapy group, adverse events, specifically subungual hematoma and blisters, occurred in 11.4% of patients, with a recurrence rate of 33.3%. No adverse events or recurrence were observed in patients treated with ciclopirox 8% HPCH.

CONCLUSIONS

Treatment of onychomycosis using diode laser and photodynamic therapy results in higher clinical cure rates and shorter healing times compared to the reference treatment with 8% ciclopirox HPCH.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05809297.