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

Abstract

<jats:sec> <jats:title>Background:</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Objectives:</jats:title> <jats:p>To compare the efficacy and safety of fractional CO<jats:sub>2</jats:sub> laser combined with topical clotrimazole to oral itraconazole plus topical clotrimazole in the treatment of onychomycosis.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods:</jats:title> <jats:p>A sample of 88 adults (between the ages of 18 and 78) was randomly divided into two groups. 45 patients received fractional CO<jats:sub>2</jats:sub> 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.</jats:p> </jats:sec> <jats:sec> <jats:title>Results:</jats:title> <jats:p>73% of patients treated with fractional ablative CO<jats:sub>2</jats:sub> laser achieved a negative KOH examination compared with 79% of the itraconazole group (P&gt;0.05). The SCIO reduction in the laser group was superior to that in the itraconazole group (P&lt;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.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusion:</jats:title> <jats:p>Fractional CO<jats:sub>2</jats:sub> 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.</jats:p> </jats:sec>

Combination of a triple wavelength (650 nm, 810 nm, and 915 nm) class IV laser system and local mechanical abrasion in the treatment of chronic toenail onychomycosis: an uncontrolled prospective pilot study

“…The results of this and other studies 9 , 10 suggest that laser therapy is not effective in treating onychomycosis. Until now laser treatments have not kept their promises in onychomycosis treatment, and well‐designed successful clinical trials are still missing.…”

“…Some of the hypotheses already published are the heat fungicidal action over fungi, keratin proteins denaturation, the possible laser influence on cellular oxidative reactions, and changes in host immune modulation. [11][12][13][14] The results of this and other studies 9,10 suggest that laser therapy is not effective in treating onychomycosis. Until now laser treatments have not kept their promises in onychomycosis treatment, and well-designed successful clinical trials are still missing.…”

“…Before starting with (laser or sham) treatment, all affected nails were ground. Similarly, Tro Van Chau et al 10 used a fractional CO 2 laser in combination with a topical antifungal drug and compared it to oral itraconazole plus the topical antifungal drug. The authors reported that the laser group showed a significantly higher clinical improvement defined as a reduction in the mean SCIO at the end of the study compared with the itraconazole group (P < 0.001), though there were no significant differences between the laser and itraconazole group in the mycological clearance rate (73.3% vs. 79.1%).…”

A comparative study on efficacy of fractional carbondioxide laser assisted topical antifungal therapy with topical antifungal therapy alone for treatment of onychomycosis in adult north Indian population

“…In contrast, other studies show that toenail onychomycosis is more common than fingernail onychomycosis 35. The low incidence of toenail onychomycosis in this study may be attributed to the use of open footwear and lesser concern for the appearance of the feet and toenails [35] .…”

The effects of CO2 laser and topical agent combination therapy for onychomycosis: A meta‐analysis

“…When compared with antifungal agent groups, few patients reported slight pain in CO 2 laser groups, and transient, minimal effects did not affect patient compliance in the continuance of treatment protocols. However, some patients in the itraconazole‐treated group from the study by Chau 11 reported gastrointestinal effects (3), abdominal pain (1) headache (2), and asymptomatic self‐limited liver transaminases elevation (2).…”