title: Imiquimod in combination with meglumine antimoniate for cutaneous leishmaniasis: a randomized assessor-blind controlled trial.
abstract: OBJECTIVE
  To determine the efficacy and safety of imiquimod in combination with meglumine antimoniate in treating cutaneous leishmaniasis.
  
  
  METHODS
  Prospective, randomized, assessor-blind, parallel-design, placebo-controlled trial.
  
  
  METHODS
  Two primary care health clinics.
  
  
  METHODS
  One hundred nineteen patients (59 patients in the imiquimod group and 60 in the placebo group) were included in the study.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  isrctn.org Identifier:ISRCTN77659407 and Cochrane Skin Group Identifier: CSG Trial No. 32.
authors.affiliation: Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Iran. firozali@sina.tums.ac.ir
authors.forename: Alireza
authors.initials: A
authors.lastname: Firooz
authors.forename: Ali
authors.initials: A
authors.lastname: Khamesipour
authors.forename: Mohammad H
authors.initials: MH
authors.lastname: Ghoorchi
authors.forename: Mansour
authors.initials: M
authors.lastname: Nassiri-Kashani
authors.forename: S Ebrahim
authors.initials: SE
authors.lastname: Eskandari
authors.forename: Alireza
authors.initials: A
authors.lastname: Khatami
authors.forename: Badakhshan
authors.initials: B
authors.lastname: Hooshmand
authors.forename: Farzam
authors.initials: F
authors.lastname: Gorouhi
authors.forename: Mehdi
authors.initials: M
authors.lastname: Rashighi-Firoozabadi
authors.forename: Yahya
authors.initials: Y
authors.lastname: Dowlati
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000634:Aminoquinolines / Q000008:administration & dosage / Q000627:therapeutic use*; D000818:Animals; D000965:Antimony; D000981:Antiprotozoal Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077271:Imiquimod; D007895:Leishmania tropica / Q000302:isolation & purification; D016773:Leishmaniasis, Cutaneous / Q000188:drug therapy* / Q000469:parasitology / Q000473:pathology; D008297:Male; D008536:Meglumine / Q000008:administration & dosage / Q000627:therapeutic use*; D000077485:Meglumine Antimoniate; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D000276:Adjuvants, Immunologic; D000634:Aminoquinolines; D000981:Antiprotozoal Agents; D009942:Organometallic Compounds; D008536:Meglumine; D000077485:Meglumine Antimoniate; D000965:Antimony; D000077271:Imiquimod