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

Arch Dermatol. 2006 Dec;142(12):1575-9. doi: 10.1001/archderm.142.12.1575.


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: Identifier:ISRCTN77659407 and Cochrane Skin Group Identifier: CSG Trial No. 32.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adjuvants, Immunologic / administration & dosage
  • Adjuvants, Immunologic / therapeutic use*
  • Adolescent
  • Adult
  • Aminoquinolines / administration & dosage
  • Aminoquinolines / therapeutic use*
  • Animals
  • Antimony
  • Antiprotozoal Agents / administration & dosage
  • Antiprotozoal Agents / therapeutic use*
  • Child
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Humans
  • Imiquimod
  • Leishmania tropica / isolation & purification
  • Leishmaniasis, Cutaneous / drug therapy*
  • Leishmaniasis, Cutaneous / parasitology
  • Leishmaniasis, Cutaneous / pathology
  • Male
  • Meglumine / administration & dosage
  • Meglumine / therapeutic use*
  • Meglumine Antimoniate
  • Middle Aged
  • Organometallic Compounds / administration & dosage
  • Organometallic Compounds / therapeutic use*
  • Prospective Studies
  • Single-Blind Method
  • Treatment Outcome


  • Adjuvants, Immunologic
  • Aminoquinolines
  • Antiprotozoal Agents
  • Organometallic Compounds
  • Meglumine
  • Meglumine Antimoniate
  • Antimony
  • Imiquimod

Associated data

  • ISRCTN/ISRCTN77659407