Efficacy of paromomycin ointment in the treatment of cutaneous leishmaniasis: results of a double-blind, randomized trial in Isfahan, Iran.

Although pentavalent antimonials are often used in the first-line treatment of cutaneous leishmaniasis (CL), they have several adverse effects. Intralesional administration of antimonials and other antileishmanial drugs can be painful. In the present, double-blind, randomized study, to determine if topical treatment with paromomycin is effective in the treatment of CL, 35 cases of CL were treated, twice daily for 30 days, with a commercial skin-care lotion containing 10% urea (the placebo) and another 30 were similarly treated with the same lotion to which paromomycin sulphate had been added (to give a concentration of 15%). Each case was assessed clinically 7, 14, 21 and 30 days after treatment began, and parasitologically 30 and 60 days after the initiation of treatment. Five (17%) and five (17%) of the cases treated with paromomycin showed complete healing, with the apparent clearance of amastigotes from their lesions, 30 and 60 days after treatment began, respectively. At the same time-points, however, the lesions on six (17%) and seven (20%) of the cases in the placebo group, respectively, also appeared to have healed completely. Ointment containing 15% paromomycin therefore appears ineffective in the treatment of CL, at least when applied twice daily for 30 days to the lesions of cases from an endemic area of Isfahan, Iran.