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Published on: April 21, 2012
Imiquimod in combination with meglumine antimoniate for cutaneous leishmaniasis: a randomized assessor-blind
Alireza Firooz1, Ali Khamesipour, Mohammad H Ghoorchi
1Center for Research and Training in Skin Diseases and Leprosy, Tehran University of Medical Sciences, Iran. firozali@sina.tums.ac.ir
Insights
Adding imiquimod cream to meglumine antimoniate treatment did not improve cure rates for cutaneous leishmaniasis. This combination therapy showed no significant benefit over standard treatment for this tropical disease.
Area of Science:
- Dermatology
- Infectious Diseases
- Clinical Pharmacology
Background:
- Cutaneous leishmaniasis is a parasitic skin infection prevalent in tropical and subtropical regions.
- Meglumine antimoniate is a standard treatment, but resistance and side effects necessitate exploring alternative therapies.
- Imiquimod is an immune response modifier with potential antileishmanial activity.
Purpose of the Study:
- To evaluate the efficacy and safety of combining 5% imiquimod cream with meglumine antimoniate for treating cutaneous leishmaniasis.
- To compare the clinical cure rates between the combination therapy and placebo plus meglumine antimoniate.
Main Methods:
- A prospective, randomized, assessor-blind, placebo-controlled trial was conducted in two primary care clinics.
- 119 patients with cutaneous leishmaniasis were randomized to receive either imiquimod or placebo alongside meglumine antimoniate for 4 weeks.
- Clinical cure was defined as >75% reduction in lesion size at week 8.
Main Results:
- Clinical cure rates at the end of treatment were similar: 18.6% for imiquimod group vs. 30.0% for placebo group (P = .15).
- At 4 weeks post-treatment, cure rates remained comparable: 44.1% (imiquimod) vs. 48.3% (placebo) (P = .64).
- Minor adverse events like pruritus and burning were reported in the imiquimod group.
Conclusions:
- Combining 5% imiquimod cream with meglumine antimoniate did not demonstrate a beneficial effect in treating cutaneous leishmaniasis caused by Leishmania tropica.
- The addition of imiquimod did not enhance the efficacy of standard meglumine antimoniate treatment.
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.
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