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A Randomized Assessor-Blind Controlled Trial

Alireza Firooz, MD; Ali Khamesipour, PhD; Mohammad H. Ghoorchi, MD; Mansour Nassiri-Kashani, MD; S. Ebrahim Eskandari, MSc; Alireza Khatami, MD; Badakhshan Hooshmand, DVM, MPH; Farzam Gorouhi, MD; Mehdi Rashighi-Firoozabadi, MD; Yahya Dowlati, MD, PhD

Arch Dermatol. 2006;142:1575-1579.

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. 32

Author Affiliations: Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences (Drs Firooz, Khamesipour, Nassiri-Kashani, Khatami, Gorouhi, Rashighi-Firoozabadi, and Dowlati and Mr Eskandari), and National Office for Zoonotic Diseases, Diseases Management Center, Ministry of Health and Medical Education (Dr Hooshmand), Tehran; and Undersecretary of Public Health, Mashad University of Medical Sciences, Mashad (Dr Ghoorchi); Iran.

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