Effectiveness and safety of Ciclopirox Olamine compared to that of Luliconazole in management of patients with multi-site dermatophytosis on background itraconazole therapy

Abstract

Wide spread, inappropriate use of antifungal drugs in dermatophytosis has resulted in rise in minimum inhibitory concentration (MIC) values and reduced response. Hence there is a need for a different antifungal with a novel mechanism of action.This was an open-label, randomised, prospective, interventional, comparative, double-arm study. The patients were treated with either topical ciclopirox olamine or luliconazole twice daily for 6 weeks. All the patients were taking oral itraconazole 100mg twice daily for 4 weeks. Effectiveness endpoints were percentage of patients achieving complete cure, clinical cure and mycological cure at the end of the treatment period from baseline. Safety was assessed by analyzing the AEs and monitoring of liver function tests. 92 patients were included in the study. 44 and 43 patients completed the study in ciclopirox and luliconazole group respectively. 84.09%, 88.63% and 86.36% patients achieved ccomplete, clinical and mycological cure rate in ciclopirox group respectively. 83.72%, 88.37% and 86.04% patients achieved complete, clinical and mycological in luliconazole group respectively. 10.63% patients in the Ciclopirox group and 10.86% in the Luliconazole group reported one or more drug related AE. Nausea, skin rash, head ache and vomiting were AEs reported. The results of this study prove that Ciclopirox is novel antifungal agent which is efficacious and safe in the management of dermatophytosis.