Comparative study of safety and efficacy of combination therapy of fractional CO2 laser and topical amorolfine cream versus oral itraconazole in the treatment of onychomycosis.

Abstract

Onychomycosis is a fungal infection of the nail unit caused by various species of dermatophytes, non-dermatophytic moulds or yeasts. They pose a therapeutic challenge to the treating dermatologist as the infection is often resistant to treatment and requires prolonged therapy. To evaluate the efficacy and safety profile of fractional CO2 laser and 0.25% Amorolfine hydrochloride cream in the treatment of onychomycosis. In this randomized controlled study on 50 patients with fingernail onychomycosis, one group (25 patients, 30 nails) were treated with fractional CO2 laser and 0.25% Amorolfine hydrochloride cream, and the second group (25 patients, 31 nails) with oral itraconazole pulse therapy. Four treatment sessions were carried out in the first group at an interval of two weeks each. Whereas, the second group received 2 doses of itraconazole pulse therapy with one month interval each. Both the groups were followed up for a period of 4months. Results were assessed by Onychomycosis severity index(OSI), Physician global assessment scale, patient's subjective score and fungal microscopy. Complete resolution was seen in 14 out of 25(56%) patients and 6 out of 25(24%) patients in group 1 and group 2 respectively. There was statistically significant difference in the response between the two groups during 1st and 2nd follow up (p value - 0.004 and 0.023 respectively). Fractional CO2 laser with amorolfine cream is proved to be a better modality in onychomycosis therapy compared to oral itraconazole pulse therapy, especially in distal lateral subungual and superficial white onychomycosis.