Efficacy of Intra-lesional Injections of Glucantime Once a Week or Twice a Week in the Treatment of Anthroponotic Cutaneous Leishmaniasis (ACL)

Study Overview
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Brief Summary
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Anthroponotic Cutaneous Leishmaniasis (ACL) is a parasitic disease caused by Leishmania tropica, pentavalent antimonials (sodium stibogluconate and meglumine antimoniate) have been used as a standard treatment for leishmaniasis for last 80 years. Systemic antimonial injection is painful, toxic, not affordable and moreover is not always effective. Many different modalities are used to treat the disease with a limited success. Intra-lesional injections of antimonials are used for the treatment of patients with a few lesions but no data is available on the rate of efficacy. In this study the efficacy of intra-lesional injections of Glucantime weekly is compared with intra-lesional injections of Glucantime twice weekly.

Official Title
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Evaluation of Efficacy of Intra-lesional Injections of Glucantime Once Weekly in Comparison With Twice Weekly in the Treatment of Acute Anthroponotic Cutaneous Leishmaniasis (ACL)

Conditions
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Cutaneous Leishmaniasis

Intervention / Treatment
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* Drug: Meglumine antimoniate
* Drug: Meglumine antimoniate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parasitologically proven cases of CL based on positive smear and/or culture Otherwise healthy subjects on the basis of medical history. Age 9-70 years Willing to participate in the study and sign the informed consent (by the patient or his/her parent/guardian in case of younger than 18 years). Exclusion Criteria: Pregnant or lactating women Duration of lesion more than 6 months Number of lesions more than 4 History of allergy to Glucantime Serious systemic illnesses (as judged by the physician) Participation in any drug trials in the last 60 days No indication for systemic treatment

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Intra-lesional injection of Glucantime once a week | Drug: Meglumine antimoniate<br>* Intra-lesional injection once a week, 0.1/cm2<br>* Other names: Glucantime;|
| Experimental: 2<br>Intra-lesional injection twice a week, 0.1/cm2 | Drug: Meglumine antimoniate<br>* Intra-lesional injection twice a week, 0.1/cm2<br>* Other names: Glucantime;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete healing of the lesion(s) |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partiall cure |  | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anthroponotic Cutaneous Leishmaniasis, L. tropica, Meglumine antimoniate (Glucantime)