Efficacy of Topical Liposomal Form of Drugs in Cutaneous Leishmaniasis

Summary

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.

Conditions

• Cutaneous Leishmaniasis

Interventions

DRUG

Liposomal meglumine antimoniate (Glucantime)

Liposomes containing meglumine antimoniate

DRUG

Liposomal meglumine antimoniate

Liposomal form of meglumine antimoniate

DRUG

Liposomal Paromomycin

Liposomal form of 10% Paromomycin

DRUG

Placebo

Placebo

Sponsors & Collaborators

• Mashhad University of Medical Sciences

  collaborator OTHER

• Center for Research and Training in Skin Diseases and Leprosy

  collaborator UNKNOWN

• Tehran University of Medical Sciences

  lead OTHER

Principal Investigators

• Masud Maleki, MD · Mashhad University of Medical Sciences, Mashhad, Iran

• Ali Khamesipour, MPH, PhD · Center for Research & Training in Skin Diseases & Leprosy, TUMS

• Mahmoud Reza Jaafari, Parm D, PhD · Mashhad University of Medical Sciences, Mashhad, Iran

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-03-31

Primary Completion

2012-01-31

Completion

2012-03-31

Countries

• Iran

Study Locations