Imiquimod in Combination With Meglumine Antimoniate for Cutaneous Leishmaniasis: A Randomized Assessor-Blind Controlled Trial

OBJECTIVE To determine the efficacy and safety of imiquimod in combination with meglumine antimoniate in treating cutaneous leishmaniasis. DESIGN Prospective, randomized, assessor-blind, parallel-design, placebo-controlled trial. SETTING Two primary care health clinics. PATIENTS One hundred nineteen patients (59 patients in the imiquimod group and 60 in the placebo group) were included in the study. INTERVENTIONS Patients were randomly assigned to receive a combined 4-week course of imiquimod or placebo with meglumine antimoniate treatment (20 mg/kg of pentavalent antimony daily for 2 weeks) in an endemic area of Leishmania tropica. MAIN OUTCOME MEASURES The primary end point was clinical cure, defined as more than 75% reduction in the size of lesions compared with baseline at week 8. RESULTS At the end of the 4-week treatment period, clinical cure was similar in both groups (11 patients [18.6%] in the imiquimod-treated group vs 18 patients [30.0%] in the placebo group) (P = .15). Four weeks after the end of treatment, 26 patients (44.1%) and 29 patients (48.3%) in the imiquimod-treated and placebo groups, respectively, were cured (P = .64). Pruritus and burning sensation were reported by 3 patients treated with imiquimod and by no patients treated with placebo. CONCLUSION This study showed no beneficial effect of combining a 4-week course of treatment with 5% imiquimod cream and a standard course of treatment with meglumine antimoniate in patients with cutaneous leishmaniasis in an endemic area of L tropica. TRIAL REGISTRATION isrctn.org Identifier:ISRCTN77659407 and Cochrane Skin Group Identifier: CSG Trial No. 32Arch Dermatol. 2006;142:1575-1579-->