Topical treatment of cutaneous leishmaniasis (CL) still poses a challenge. Amphotericin B, a potent antileishmanial antibiotic, is commonly administered intravenously. However, because amphotericin B is highly toxic and particularly nephrotoxic when given systemically, it is usually reserved for patients whose condition fails to respond to other treatments.1
We have recently found in a mouse model that amphotericin B administered topically as a complex either with cholesteryl sulfate or with phospholipids, in the presence of ethanol, can penetrate into the skin and cure cutaneous leishmaniasis in a localized manner using very low total drug concentrations.2 The aim of the present study was to assess the efficacy of an ethanolic amphotericin B–lipid formulation in patients with CL in a prospective, placebo-controlled trial.