Fractional Carbon-Dioxide Laser Plus Topical Clotrimazole versus Oral Itraconazole plus Topical Clotrimazole for Onychomycosis: A Randomized, Controlled Trial

Abstract

Background: Treating onychomycosis is problematic for a variety of reasons. The very nature of the hard, protective nail plate itself makes it difficult for topical drugs to reach the fungal pathogens beneath it. Oral therapy is more effective than topical therapy, but it is expensive, requires monitoring for toxicity, and can result in multiple drug interactions. Objectives: To compare the efficacy and safety of fractional CO2 laser combined with topical clotrimazole to oral itraconazole plus topical clotrimazole in the treatment of onychomycosis. Methods: A sample of 88 adults (between the ages of 18 and 78) was randomly divided into two groups. 45 patients received fractional CO2 laser therapy at an interval of 2 weeks and twice-daily application of clotrimazole 1% cream. 43 patients were treated by pulsed itraconazole (200 mg twice daily, 1 week on, 3 weeks off) and twice-daily application of clotrimazole 1% cream. The duration of the treatment was 3 months for fingernails and 4 months for toenails in both groups. The clinical effect was measured using the Scoring Clinical Index for Onychomycosis (SCIO index), KOH examination for the affected nails were performed, and liver function tests in the two groups were analyzed. Results: 73% of patients treated with fractional ablative CO2 laser achieved a negative KOH examination compared with 79% of the itraconazole group (P>0.05). The SCIO reduction in the laser group was superior to that in the itraconazole group (P<0.001). Notably, a biochemical abnormality was not documented in patients who received laser treatment. In contrast, liver transaminases elevations without clinical symptoms were documented in two patients at the end of itraconazole therapy. Conclusion: Fractional CO2 laser plus a topical antifungal drug might be more clinically effective in the treatment of onychomycosis than itraconazole, without any adverse reactions. It could be an alternative for clinicians in onychomycosis cases in which oral antifungal agents are contraindicated.