Efficacy of Topical Liposomal Form of Drugs in Cutaneous Leishmaniasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-03-31

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.

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Detailed Description

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Conditions

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Cutaneous Leishmaniasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Liposomal Paromomycin

Liposomes containing 10% Paromomycin

Group Type EXPERIMENTAL

Liposomal meglumine antimoniate

Intervention Type DRUG

Liposomal form of meglumine antimoniate

Liposomal Paromomycin

Intervention Type DRUG

Liposomal form of 10% Paromomycin

Liposomal meglumine antimoniate

Liposomes containing meglumine antimonate

Group Type EXPERIMENTAL

Liposomal meglumine antimoniate (Glucantime)

Intervention Type DRUG

Liposomes containing meglumine antimoniate

Liposomal meglumine antimoniate

Intervention Type DRUG

Liposomal form of meglumine antimoniate

Placebo

Group Type PLACEBO_COMPARATOR

Liposomal meglumine antimoniate

Intervention Type DRUG

Liposomal form of meglumine antimoniate

Placebo

Intervention Type DRUG

Placebo

Interventions

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Liposomal meglumine antimoniate (Glucantime)

Liposomes containing meglumine antimoniate

Intervention Type DRUG

Liposomal meglumine antimoniate

Liposomal form of meglumine antimoniate

Intervention Type DRUG

Liposomal Paromomycin

Liposomal form of 10% Paromomycin

Intervention Type DRUG

Placebo

Intervention Type DRUG

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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No