A Retrospective Study of Non-thermal Laser Therapy for the Treatment of Toenail Onychomycosis

Objective: The objective of this study was to assess the efficacy of non-thermal laser therapy for treating toenail onychomycosis. Design: This retrospective study analyzed the results of three nonrandomized, open-label studies. The device used was a 635nm/405nm dual-diode laser. Affected toenails were treated for 12 minutes weekly for 2 or 4 weeks. Setting: Treatments occurred in clinic and private office settings. Participants: Subjects with onychomycosis-infected toenails were enrolled. Measurements: Fifty great toenails were included in the analysis based on visually identifiable onychomycosis; thickened, discolored nail plate; and confirmed etiology of onychomycosis. Changes in the extent of clear nail bed was measured using multi-platform image manipulation software. The primary outcome measure was the percent of toenails attaining ≥3mm of clear nail growth during the six-month post-treatment period. Overall study success was defined as ≥60 percent of treated toenails meeting the individual success criteria. The secondary outcome measure was change in the length of clear nail bed. Results: Most treated toenails (67%) achieved individual treatment success. The extent of clear nail at baseline increased by a mean of 5.18 (4.76) mm after 6 months (p<0.0001). In addition, 89 percent of treated toenails demonstrated an increase in clear nail across the six-month study period. No adverse events were reported. Conclusion: Non-thermal laser therapy is safe and effective for increasing the extent of clear nail in onychomycosis-infected toenails following one weekly treatment for four weeks. ClinicalTrials.gov Identifier: NCT02588599.