Efficacy of Topical Liposomal Form of Drugs in Cutaneous Leishmaniasis
Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
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.
Phase:
Early Phase 1
Details
Lead Sponsor:
Tehran University of Medical Sciences
Collaborators:
Center for Research and Training in Skin Diseases and Leprosy Mashhad University of Medical Sciences