Background: Laser therapy is a rapidly expanding new treatment modality for onychomycosis.
Objective: To review current and prospective laser systems for the treatment of onychomycosis.
Method: We searched the PubMed database, the Food and Drug Administration 510(k) database, ClinicalTrials.gov, and Google Scholar for in vitro studies, peer-reviewed clinical trials, manufacturers' white papers, and registered clinical trials of laser systems indicated for the treatment of onychomycosis. All published clinical trials were assessed on a 20-point methodological quality scale.
Results: We identified three basic science articles, five peer-reviewed articles, three white papers, and four pending clinical trials, as well as numerous gray literature documents. The overall methodological score for the clinical trials was 9.1 ± 1.1, with peer-reviewed studies showing a higher score (9.8 ± 1.5) than white papers (7.5 ± 0.7). We also identified 11 commercial laser device systems of varying global availability.
Conclusion: Laser therapy has been tested and approved as a cosmetic treatment only for onychomycosis. It cannot be recommended as a therapeutic intervention to eradicate fungal infection at this time as more rigorous randomized, controlled trials are required to determine if laser therapy is efficacious on par with oral and topical interventions.