Comparative study of fractional carbon dioxide laser with oral itraconazole versus oral itraconazole alone in the treatment of onychomycosis – A randomised controlled trial

Background: Onychomycosis accounts for 20–40% of all nail disorders, and treatment is challenging due to resistance and side effects of antifungal drugs. Itraconazole is a commonly used oral medication for onychomycosis. The rapid appearance, concentration and persistence of itraconazole in the nail plate makes the intermittent dosing regimen as efficacious as the daily regimen. On the other hand, the fractional carbon dioxide (CO2) laser has also demonstrated promising results in treating onychomycosis due to its selective photothermolytic action. Objectives: The objective of the study is to compare the efficacy and safety of oral super bioavailable itraconazole with fractional CO2 laser combined with oral itraconazole in the treatment of onychomycosis. Material and Methods: A single-centre randomised controlled trial was conducted with patients randomised in two groups – group A receiving combined oral and laser therapy and group B receiving only oral therapy. Patients were followed up every month for 3 months, with clinical assessment carried out using the onychomycosis severity index (OSI) along with dermoscopic changes, which were assessed at the baseline and 3 rd month. Results: A total of 60 patients (264 nails) were included in our study, with 30 patients in each group. The mean reduction in OSI with treatment in group A was 3.53 ± 5.09 and in group B, it was 0.86 ± 4.22. This OSI difference between the two groups was statistically significant (p<0.0043). Group A showed greater improvement across all dermoscopic findings, with significant improvement in onycholysis, spiked pattern, chromonychia and longitudinal and transverse striations. Conclusion: Combining fractional CO2 laser therapy with oral itraconazole is significantly more effective than oral therapy alone. This can be especially useful for patients with multiple affected nails, older patients, those with co-morbidities such as diabetes and hypertension and for females, particularly housewives. Dermoscopy has proved valuable in monitoring treatment responses, enhancing accuracy in patient care. Notably, no side effects were observed in our study, underscoring the improved safety and efficacy of this combined approach for treating onychomycosis.