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.