Randomized Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy with Short-Pulsed 1,064-nm Neodymium-Doped Yttrium Aluminium Garnet Laser and Amorolfine Nail Lacquer for Onychomycosis

ABSTRACT

BACKGROUND: Onychomycosis is one of the most prevalent fungal diseases in the general population. However, treatment is of limited effectiveness and must be administered for long periods of time. Systemic antifungal agents are associated with adverse effects. OBJECTIVE: We evaluated the clinical efficacy and safety of a 1,064-nm neodymium-doped yttrium aluminium garnet (NdYAG) laser with amorolfine nail lacquer to treat onychomycosis. METHODS: The 128 patients were randomly divided to 2 groups 64 in the experimental group were treated with 1,064-nm NdYAG laser therapy and amorolfine nail lacquer; the other 64 were in a control group treated with topical amorolfine lacquer monotherapy. The laser treatment was 4 sessions at 4-week intervals and amorolfine lacquer was applied once a week for 16 weeks. Efficacy was assessed as response rate from standardized photographs with ImagePro®Plus (Media Cybernetics, Inc., USA) analysis, microscopic examination, and subjective evaluation. RESULTS: At 16 weeks, the experimental group showed a significantly higher cumulative cure rate than the control group (71.88% vs. 20.31%, p<0.0001). Clinical therapeutic effects were linked to patient satisfaction. The percent of “very satisfied” or “satisfied” responses was higher in the test group than the control group (81.25% vs. 23.44%). The treatment regimen was well tolerated, with transient discomfort observed in the test group. CONCLUSION: The 1,064-nm NdYAG laser with amorolfine nail lacquer was effective and safe for treating onychomycosis. This therapy should be considered an alternative treatment, especially for patients with contraindications to systemic antifungal agents.