Imiquimod in combination with meglumine antimoniate for cutaneous leishmaniasis: A randomized assessor-blind controlled trial

Firooz, A. and Khamesipour, A. and Ghoorchi, M. H. and Nassiri-Kashani, M. and Eskandari, S. E. and Khatami, A. and Hooshmand, B. and Gorouhi, F. and Rashighi-Firoozabadi, M. and Dowlati, Y. (2006) Imiquimod in combination with meglumine antimoniate for cutaneous leishmaniasis: A randomized assessor-blind controlled trial. Archives of Dermatology, 142 (12). pp. 1575-1579.

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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. ©2006 American Medical Association. All rights reserved.

Item Type: Article
Additional Information: Cited By :75 Export Date: 16 February 2020 CODEN: ARDEA Correspondence Address: Firooz, A.; Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, 79 Taleghani Ave, Tehran 14166, Iran; email:
Uncontrolled Keywords: imiquimod meglumine antimonate placebo adolescent adult article burning sensation clinical practice clinical trial controlled clinical trial controlled study drug efficacy drug safety drug withdrawal endemic disease female health center human major clinical study male priority journal prospective study pruritus randomized controlled trial skin leishmaniasis treatment duration treatment response Adjuvants, Immunologic Aminoquinolines Animals Antimony Antiprotozoal Agents Child Drug Therapy, Combination Follow-Up Studies Humans Leishmania tropica Leishmaniasis, Cutaneous Meglumine Middle Aged Organometallic Compounds Prospective Studies Single-Blind Method Treatment Outcome
Subjects: WR Dermatology
QW Microbiology and Immunology
Divisions: Mashhad University of Medical Sciences
Depositing User: mr lib7 lib7
Date Deposited: 29 Apr 2020 05:38
Last Modified: 29 Apr 2020 05:38

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