Fractional CO2 laser with topical 1% terbinafine cream versus oral itraconazole in the management of onychomycosis: A randomized controlled trial

ABSTRACT

Background: Onychomycosis accounts for 20–40% of all nail disorders. It is difficult to cure with resistance to anti-fungal drugs, their side effects and drug interactions limiting treatment options. Itraconazole is a widely accepted oral medication used for onychomycosis while fractional CO2 laser along with a topical anti-fungal has shown promising results for nail plate clearance in onychomycosis. Aim: To compare the efficacy of fractional CO2 laser with 1% terbinafine cream versus itraconazole in the management of onychomycosis. Methods: A prospective, randomised, single-centre, two-arm, parallel-group interventional study was conducted at Command Hospital Air Force, Bangalore. Onychomycosis cases confirmed by KOH mount/culture-positive were included. Patients were randomly divided into two groups. Group A received 4 sessions of fractional CO2 laser every fourth week with twice-daily application of 1% terbinafine cream; Group B received one-week pulse therapy with capsule itraconazole once every four-week for three pulses. The response was assessed by Onychomycosis Severity Index, a validated onychomycosis assessment scale, at baseline and at six months. Results: Group A had 50 patients with a total of 98 nails. Clinical improvement was seen in 83/98 (84.7%) nails. The average reduction in Onychomycosis Severity Index was 8.65 (P < 0.05). Group B had 50 patients with a total of 136 nails. Clinical improvement was seen in 104/136 (76.5%) nails. The average reduction in Onychomycosis Severity Index was 7.37 (P < 0.05). Both groups showed statistically significant improvement measured by ‘Reduction in Onychomycosis Severity Index’ at six months; however, there was no significant difference between the two arms. Limitations: The main limitations of the study are the small sample size and lack of long-term follow-up to assess recurrence of infection. Conclusion: Fractional CO2 laser with 1% terbinafine cream is an effective and safe method for inducing nail clearance in onychomycosis and has efficacy similar to itraconazole pulse therapy.