Safety and efficacy of intralesional amphotericin B in the treatment of Old World cutaneous leishmaniasis: a nonrandomized open-label prospective study.

BACKGROUND

Cutaneous leishmaniasis (CL) is a neglected tropical disease with limited accessible treatment options. Although pentavalent antimonials remain the gold standard, emergence of drug resistance and recurrent stockouts pose significant challenges. Amphotericin B is a well-established treatment of visceral leishmaniasis; however, its use in Old World CL (OWCL), particularly via the intralesional route and using conventional formulations, has been studied only anecdotally to the best of our knowledge.

OBJECTIVES

To evaluate the safety and efficacy of intralesional amphotericin B deoxycholate in the treatment of OWCL.

METHODS

A nonrandomized prospective study was conducted to evaluate the safety and efficacy of intralesional amphotericin B in OWCL. All patients with CL who were treatment naïve and with ≤ 5 skin lesions were included. Amphotericin B deoxycholate (2.5 mg mL-1) was administered intralesionally at weekly intervals for up to 8 weeks, or until a complete clinical response, whichever occurred first. Treatment response was assessed at 4, 8 and 12 weeks. Treatment responders were followed for 6 months to record recurrence.

RESULTS

In total, 50 patients with 61 skin lesions were included in the analysis. At 12 weeks, 44 (88%) patients showed a complete response and the overall cure rate was 96% (48/50). Treatment response was not affected by the disease duration, lesion site or morphology. All treatment responders remained recurrence-free at the 6-month follow-up. Reported side effects were mild and self-limiting.

CONCLUSIONS

Intralesional amphotericin B deoxycholate was found to be effective and safe in the treatment of OWCL. The study is limited by the small sample size, lack of a control group and nonavailability of species typing.