Fluconazole for the Treatment of Cutaneous Leishmaniasis Caused byLeishmania major

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Abstract
Whereas certain oral antifungal azoles are well documented to have activity against leishmania, data on the efficacy of fluconazole for leishmaniasis are limited. We conducted a controlled trial in Saudi Arabia of fluconazole for the treatment of cutaneous leishmaniasis caused by Leishmania major. This randomized, double-blind, placebo-controlled trial assessed the efficacy of oral fluconazole, in a dose of 200 mg daily for six weeks, in the treatment of parasitologically confirmed cutaneous leishmaniasis. The primary outcome measure was the time to the complete healing of all lesions. A total of 106 patients were assigned to receive fluconazole, and 103 patients were assigned to receive placebo. Follow-up data were available for 80 and 65 patients, respectively. At the three-month follow-up, healing of lesions was complete for 63 of the 80 patients in the fluconazole group (79 percent) and 22 of the 65 patients in the placebo group (34 percent; relative risk of complete healing, 2.33 [95 percent confidence interval, 1.63 to 3.33]). According to an intention-to-treat analysis, the rates of healing were 59 percent and 22 percent, respectively (relative risk, 2.76 [95 percent confidence interval, 1.84 to 4.12]). Sodium stibogluconate was offered to 11 patients in the fluconazole group who returned for follow-up (14 percent) and 33 of those in the placebo group (51 percent) in whom oral treatment was judged to have failed. According to a Kaplan–Meier analysis, the time to healing was shorter for the fluconazole group (median, 8.5 weeks, as compared with 11.2 weeks in the placebo group; PL. major.

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