Effectiveness and safety of combination of Itraconazole and Amorolfine in management of patients with recalcitrant multi-site dermatophytosis who failed previous combination antifungal therapy

Abstract

There is alarming rise in cases of dermatophytosis in India.Standard treatment recommendations are no longer working. Combination of topical and systemic antifungal drugs is one of the most frequently used treatment strategy.This was an open label, prospective, interventional, non-comparative study. 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. 66 patients were included in the study. 75.75%, 86.36% and 81.8% patients achieved complete cure, clinical cure and mycological cure respectively at the end of the study period. There was improvement in each symptom during study duration as observed during each follow up visit on week 2, 4 and 6. Total of 10.60% reported 1 or more drug related AE. Nausea was most common side effect followed by vomiting, headache and edema of face. All the AEs were mild in nature and resolved during study. To conclude the result of this study shows that the combination therapy of oral itraconazole and topical amorolfine represents an improved treatment strategy for patients with recalcitrant multisite tinea infections.