Efficacy of combination therapy with oral fluconazole and topical cryotherapy on cutaneous leishmaniasis lesions in comparison to topical cryotherapy alone

In the present study combination treatment with oral fluconazole and cryotherapy is compared to cryotherapy alone to evaluate for any increased efficacy. New cases of smear positive cutaneous leishmaniasis with negative past history of leishmaniais sequentially enroll in the groups of the study at the time of presentation for treatment while those with pregnancy or lactation, location on the face and ear or more than 10 lesions are excluded. The study is designed as a randomized double blind clinical trial with required number of 30 participant in each group of cases and controls.To blind for the patient and assessors the drug and placebo were packed identically in the pharmacy as 50 mg capsules so that the only difference is the assigned letter A or B. Statistical analyst is also blinded. Allocation to groups achieved according to randomized block design (AB and BA). Duration of drug treatment is 6 weeks but cryotherapy continues till complete re-epithelialization. Each enrolling patient (case or control) is examined and required parameters of the lesions including the diameter,degree of induration and area of ulcer are registered at the beginning of the treatment and weekly. Evaluation for primary outcome (final recovery) is done at the end of 6th week when another smear of leishmania is done and 4 weeks later. Definition for outcome is as follows: Complete recovery equals to absence of induration and complete re-epithelialization during the treatment period and the following 4 weeks; No recovery is defined as positive smear or less than 50% reduction in induration and partial recovery means negative smear and more than 50% reduction in induration.

Vice-Chancellery of Research of Fasa University of Medical Sciences