Itraconazole in the treatment of New World mucocutaneous leishmaniasis

Background A well-tolerated oral drug is required for the treatment of mucocutaneous leishmaniasis (MCL). Current parenteral treatment regimens with pentavalent antimonials are associated with marked toxicity and significant rates of relapse. Aim To evaluate the efficacy and tolerability of high-dose itraconazole for the treatment of MCL. Methods An uncontrolled treatment study was performed in 13 Ecuadorian patients with MCL. Each patient received a daily dosage of 400 mg of itraconazole for a minimum of 3 months. Results All 13 subjects responded to itraconazole during the first month of treatment, but by 12 months after treatment the complete resolution of MCL lesions was observed in only three (23%) subjects. No adverse effects of treatment were reported. Response to treatment was associated with a short evolution of the disease and mild to moderate disease severity. Conclusion Prolonged and high-dose treatment regimens with itraconazole are not effective for the treatment of the majority of patients with MCL.