MichaelBigbyMDRosamariaCoronaDSc, MDDamianoAbeniMD,MPHPaoloPasquiniMD,MPHMoysesSzkloMD, MPH, DrPHHywelWilliamsMD
Question: Is fluconazole effective and safe compared with placebo to treat cutaneous leishmaniasis caused by Leishmania major in immunocompetent adults?
Design: Alrajhi et al conducted a controlled clinical trial in Saudi Arabia using fluconazole for the treatment of cutaneous leishmaniasis caused by L major. In a 6-week placebo-controlled trial, 248 patients were screened, and 209 were allocated in the 2 groups using a random-number table. Sample size calculation was declared, and inclusion/exclusion criteria defined. Patients were observed for a mean of 72 days after the completion of the trial. The diagnosis was confirmed by parasitologic smear and/or culture, but the type of Leishmania was reported in only 27% of the randomized patients (all were L major). Local care and topical antibiotics were used on lesions if a secondary bacterial infection was suspected. Lesions were evaluated every 2 weeks for 6 weeks, then every month for 3 months, then every 3 months until the end of 12 months. All patients were monitored for adverse events. An intention-to-treat analysis was used (more than 90% of the patients randomized in the trial were included in the analysis).
González U. Fluconazole for Cutaneous Leishmaniasis: Looking for a Better Treatment. Arch Dermatol. 2002;138(12):1604-1606. doi:10.1001/archderm.138.12.1604