Efficacy of Topical Liposomal Form of Drugs in Cutaneous Leishmaniasis

Study Overview
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Brief Summary
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Leishmaniasis with diverse clinical manifestations is caused by different species of Leishmania and is endemic in many countries. Although Cutaneous Leishmaniasis (CL) is a self-healing disease, but it takes a long time to heal. Pentavalent antimonials are still the first-line treatment of CL which needs multiple injections, are painful and as such not tolerated by most of the patients, in addition available treatments are not always effective and resistance is reported. Paromomycin sulfate (PM) reported to show anti-Leishmania activity against both CL and visceral leishmaniasis (VL) since 1960s. Therapeutic strategy with high efficacy is urgently needed especially for Anthroponotic Cutaneous Leishmaniasis (ACL). Liposomes are lipid bilayer molecules which entrap water-soluble molecules in their internal water compartment and water-insoluble ones into their lipid bilayers. Liposomes, in proper formulations and sizes, deliver drugs to the skin based on the similarity of the bilayers structure of lipid vesicles to that of natural membrane and target the macrophages within dermis. Several lipid-based formulations have been developed to treat experimental leishmaniasis. Recently different doses of liposomal formulation of PM and liposomal formulation of Glucantime were prepared and showed high efficacy in vivo against L. major infection in BALB/c mice. In this study the efficacy of liposomal formulation of PM or liposomal formulation of Glucantime in combination with systemic Glucantime in the treatment of ACL parasitologically proven patients will be evaluated. The clinical trial will be carried out according to the International approved GCP (Good Clinical Practice) guide lines.

Official Title
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Pilot Study of Efficacy of Topical Nano-liposomal Meglumine Antimoniate (Glucantime) or Paromomycin in Combination With Systemic Glucantime for the Treatment of Anthroponotic Cutaneous Leishmaniasis (ACL) Caused by Leishmania Tropica

Conditions
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Cutaneous Leishmaniasis

Intervention / Treatment
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* Drug: Liposomal meglumine antimoniate (Glucantime)
* Drug: Liposomal meglumine antimoniate
* Drug: Liposomal Paromomycin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged between 12 to 60 years. Parasitologically proven CL due to L. tropica. History of failure to at least one full course of systemic Glucantime. In general good health based on history and physical examination. Number of lesion at most 4. Lesion size less than 3 cm. Signed informed consent voluntarily and knowingly. Guardian's signature for volunteer less than 18 years old. Exclusion Criteria: Pregnant or lactating women and those who are planning to be pregnant in next 60 days. Use of other types of treatment for CL. Involvement in any other drug or vaccine trial during the study period. Known heart, kidney, liver diseases based on history and physical exam. Abnormal ECG.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 60 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposomal Paromomycin<br>Liposomes containing 10% Paromomycin | Drug: Liposomal meglumine antimoniate<br>* Liposomal form of meglumine antimoniate<br>Drug: Liposomal Paromomycin<br>* Liposomal form of 10% Paromomycin<br>|
| Experimental: Liposomal meglumine antimoniate<br>Liposomes containing meglumine antimonate | Drug: Liposomal meglumine antimoniate (Glucantime)<br>* Liposomes containing meglumine antimoniate<br>Drug: Liposomal meglumine antimoniate<br>* Liposomal form of meglumine antimoniate<br>|
| Placebo Comparator: Placebo<br> | Drug: Liposomal meglumine antimoniate<br>* Liposomal form of meglumine antimoniate<br>Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete cure equal to Complete Re-epithelization of all lesions |  | 200 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cutaneous Leishmaniasis caused by l. tropica