An Early Phase 1 interventional study of Liposomal meglumine antimoniate (Glucantime) and Liposomal meglumine antimoniate in Cutaneous Leishmaniasis, sponsored by Tehran University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 12 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-06-20.
Sponsored by Tehran University of Medical Sciences · Early Phase 1, Interventional, and Supportive care
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.
185 studies on the registry are indexed under Leishmaniasis; 15 are open to participants now.
This study's planned enrollment of 30 is below the median of 80 across 133 interventional studies indexed under Leishmaniasis.
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Exclusion Criteria:
Liposomes containing 10% Paromomycin
Drug: Liposomal meglumine antimoniate · Drug: Liposomal Paromomycin
Liposomes containing meglumine antimonate
Drug: Liposomal meglumine antimoniate (Glucantime) · Drug: Liposomal meglumine antimoniate
Drug: Liposomal meglumine antimoniate · Drug: Placebo
Liposomes containing meglumine antimoniate
Liposomal form of meglumine antimoniate
Liposomal form of 10% Paromomycin
Placebo
Complete cure equal to Complete Re-epithelization of all lesions
Time frame: 200 days
This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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Tehran University of Medical Sciences