Prospective efficacy and safety evaluation of laser treatments with real-time temperature feedback for fungal onychomycosis.

BACKGROUND AND OBJECTIVES: Onychomycosis affects five percent of the worldwide population. Onychomycosis is a therapeutic challenge. Current therapies on the market are either ineffective or require patient monitoring. Laser and light technologies are being investigated as a possible treatment option for onychomycosis. The proposed mechanism of action is unknown. All infectious agents may be killed by heat (except prions). One possible theory is the photothermal effect from water absorbing lasers creates bulk heating in the nail plate to kill fungal hyphae. Laser technology may be a promising new treatment option for onychomycosis. This is a prospective trial with real-time temperature feedback to evaluate efficacy and safety of laser therapy for onychomycosis. METHODS: Twenty-one patients with PAS or culture proven fungal onychomycosis were prospectively treated with laser until target temperature of 46 - 48 degrees Celsius was achieved using real-time infrared temperature feedback. The laser and light therapies used were 1319 nm, 1064 nm and BroadBand Light. Exclusion criteria included mixed infection and no other prior therapeutic interventions. Subjects received four treatment sessions one week apart. Assessments included PAS & cultures at one, three and six months post treatment. Patients also were asked a pain score from 1-10 during treatment. RESULTS: Patients tolerated the procedures well with high satisfaction. Average treatment time was 10 minutes. No adverse events were noted. Patients reported mild-moderate transient discomfort during treatment. Six-month culture results revealed 20/21 negative for fungal organisms. CONCLUSION: Laser therapy offers a safe and effective new option for onychomycosis. This may be the optimal therapy for a large market that needs alternative or adjunct to current therapies. Laser is quick, painless therapy that does not require any oral medications or blood test for monitoring. Additional larger scientific studies are needed to confirm our pilot study results.