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.