A randomized, double-blind, placebo-controlled clinical trial of itraconazole in the treatment of cutaneous leishmaniasis

BACKGROUND: Several modalities have been used for the treatment of cutaneous leishmaniasis (CL) with various results. In vitro and in vivo studies have shown inhibitory effects of azole drugs on Leishmania parasites. OBJECTIVES: To evaluate the efficacy and tolerability of oral itraconazole in the treatment of CL caused by L. major. METHODS: A total of 200 patients with parasitologically confirmed CL with a duration of less than 45 days from a well known L. major endemic area were included in a randomized, double-blind, placebo-controlled clinical trial. The patients received either itraconazole 200 mg daily (100 patients) or placebo (100 patients) for 8 weeks. The primary outcome measures were clinical cure (complete re-epithelization of all lesions) and parasitological cure at the end of the treatment. RESULTS: Eighty-three patients in the itraconazole and 75 patients in the placebo group completed the treatment course. After 8 weeks of treatment, clinical cure was observed in 59% and 53% and parasitological cure was observed in 83% and 76% of patients in the itraconazole and placebo groups, respectively, which were not significantly different. There was no difference in the rate of adverse events. CONCLUSIONS: An 8-week course of oral itraconazole was not more effective than placebo in the treatment of CL.