A randomized clinical trial of topical paromomycin versus oral ketoconazole for treating cutaneous leishmaniasis in Turkey.

An open-labeled, randomized clinical trial to evaluate the efficacy of paromomycin ointment as compared with ketoconazole was conducted on seventy-two patients of both sexes and different ages with the confirmed diagnosis of cutaneous leishmaniasis (CL). All patients had a complete clinical evaluation for other diseases. Patients were excluded if they were pregnant or nursing or if they had serious concomitant diseases. Patients were divided randomly into two treatment groups: in the first group 40 patients were treated with an ointment containing 15% paromomycin sulfate and 12% methylbenzothonium chloride in white soft paraffin (labeled as p-ointment by El-On1) twice daily for 15 days. Treated lesions were left uncovered. The second group consisted of 32 patients who received ketoconazole 400 mg/day orally for 30 days. This dosage was reduced to 200 mg/day for patients below 12 years of age. In all cases the diagnosis was based on positive smear and/or culture. Direct smears were prepared from the exudate obtained by a small incision made at the edge of the lesion with a sterile surgical blade or lancet and stained using the Giemsa method for leishmania bodies (Fig 1). In smear negative and suspected cases aspirates taken by puncturing the lesions were inoculated onto NNN (Novy, McNeal, Nicolle) medium for culture. The cultures were incubated at 28 degrees C and the development of motile promastigotes was observed. Clinical and parasitological evaluations of the patients were performed at the end of the treatment period and 4 weeks post-treatment. A cure was defined as complete healing and disappearance of the lesion or reversible hypopigmentation at the site of lesion. Incomplete or partial improvement was defined as a reduction in the size of a lesion and the absence of parasites on smear or culture. A treatment failure was defined as the absence of any changes in the lesion and persistence of parasites on smear or culture.