Treatment of cutaneous leishmaniasis with itraconazole. Randomized double-blind study.

OBJECTIVE

To compare the efficacy of itraconazole with placebo in the treatment of cutaneous leishmaniasis caused by Leishmania major.

DESIGN

Double-blind placebo-controlled study.

SETTING

Patients were selected from volunteers wit cutaneous leishmaniasis who lived in a hyperendemic area.

PATIENTS

One hundred forty patients were randomly selected for this double-blind study. Exclusion criteria were pregnancy, gestation, age younger than 12 years, and duration of disease of more than 4 months.

INTERVENTION

Each patient received itraconazole (7 mg/kg per day) or placebo for a 3-week period. The patients were kept under observation for an additional 30-day period. OUTCOME. The study was completed as planned in 131 patients.

RESULTS

Complete healing occurred in 59% of the itraconazole group in comparison with 44.3% of the patients who were treated with placebo capsules. No difference was found between the 2 groups with respect to adverse effects.

CONCLUSIONS

Although itraconazole has the advantage of being an oral agent that is used in the treatment of cutaneous leishmaniasis, the low response rate in patients receiving itraconazole indicates that itraconazole cannot be used as the single agent in the treatment of patients with cutaneous leishmaniasis caused by L. major.