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Leishmaniasis clinical trials

View clinical trials related to Leishmaniasis.

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NCT ID: NCT01050777 Completed - Clinical trials for Cutaneous Leishmaniasis

Efficacy of Topical Liposomal Form of Drugs in Cutaneous Leishmaniasis

Start date: March 2011
Phase: Phase 0
Study type: Interventional

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.

NCT ID: NCT01032382 Completed - Clinical trials for Leishmaniasis, Cutaneous

Safety, Efficacy and Pharmacokinetics (PK) Study of WR 279,396 Versus Paromomycin for Treatment of Cutaneous Leishmaniasis (Peru-PK)

Start date: January 2010
Phase: Phase 2
Study type: Interventional

The objectives of the study are to evaluate the pharmacokinetics (PK), safety, and efficacy of WR 279,396 (Paromomycin + Gentamicin Topical Cream) and Paromomycin Topical Cream in subjects with cutaneous leishmaniasis (CL).

NCT ID: NCT01032187 Completed - Clinical trials for Visceral Leishmaniasis

Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children

LVTO
Start date: October 2007
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if amphotericin B is effective against visceral leishmaniasis in Brazilian children. Amphotericin B will be compared to meglumine antimoniate which is the current approved drug used for this disease in Brazil.

NCT ID: NCT01011309 Completed - Clinical trials for Cutaneous Leishmaniasis

A Study of the Efficacy and Safety of the LEISH-F2 + MPL-SE Vaccine for Treatment of Cutaneous Leishmaniasis

Start date: October 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the efficacy, safety, and immunogenicity of an investigational vaccine being developed for the treatment of leishmaniasis, including cutaneous leishmaniasis (CL). The vaccine, identified as LEISH-F2 + MPL-SE, consists of a Leishmania protein (LEISH-F2) together with an adjuvant MPL-SE.

NCT ID: NCT00996463 Completed - Wound Healing Clinical Trials

Rationales for Wound Care Management in Old World Cutaneous Leishmaniasis Patients

LEICO
Start date: January 2010
Phase: Phase 2
Study type: Interventional

The rationales of a clinical trial comparing intralesional antimonial therapy versus wound care management in patients with old world cutaneous leishmaniasis (OWCL) are the following: 1. The effectiveness of the current mainstay treatment with intralesional antimonials for CL is subject to discussion, especially in L. major lesions which are predominant in Northern Afghanistan 2. The importance of wound care management in patients with OWCL has been emphasized by Gonzalez et al. (2008) and its efficacy is confirmed in the Kabul trial with L. tropica patients. Parallel to the clinical efficacy the trial investigates the cost-effectiveness and -utility of the treatment options under study.

NCT ID: NCT00982774 Completed - Clinical trials for Post Kala Azar Dermal Leishmaniasis

Safety and Immunogenicity of the LEISH-F2 + MPL-SE Vaccine With SSG for Patients With PKDL

Start date: April 2009
Phase: Phase 1
Study type: Interventional

A phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of three injections of 10 µg LEISH-F2 + 25 µg MPL-SE given at 14-day intervals as an adjunct to standard chemotherapy with sodium stibogluconate (20 mg/kg/day for 40 days) in patients with PKDL.

NCT ID: NCT00973128 Completed - Clinical trials for Cutaneous Leishmaniasis

Reduced Doses of Antimony Plus Ranulocyte Monocyte Colony Stimulating Factor (GM-CSF) for Cutaneous Leishmaniasis

GMCSFSbv
Start date: February 2004
Phase: Phase 2
Study type: Interventional

The present study was designed as a randomized, single blind, placebo-controlled, study to evaluate the effect of 400 µg of recombinant human GM-CSF applied intralesionally and associated with half of the total dose of antimony in a reduced time schedule (20mgSbV/Kg/d for 10 days) as compared to the full dose of antimony (20mgSbV/Kg/d for 20 days) to treat cutaneous leishmaniasis ulcers.

NCT ID: NCT00947362 Completed - Wound Healing Clinical Trials

Rationale for New Topical Anthroponotic Cutaneous Leishmaniasis (ACL) Treatment in Kabul

rtt-ACL
Start date: August 2004
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of the randomized double blind trial with 134 patients presenting old world cutaneous leishmaniasis is: - to evaluate the clinical efficacy of electro-thermo-cauterisation (ETC) followed by moist wound treatment versus ETC followed by moist wound treatment plus 0.05 % pharmaceutical chlorite that has been used in three European countries (Germany, Austria and Switzerland) in wound care management for more than 20 years; - to judge whether early wound care management would present a viable improvement to the actual anti-parasitic treatments mostly neglecting the chronic wound problem and to evaluate its long-term effect on immunity through relapse control 6 months after wound healing.

NCT ID: NCT00884377 Completed - Clinical trials for Cutaneous Leishmaniasis

Local Heat Therapy Versus Sodium Stibogluconate for the Treatment of Cutaneous Leishmaniasis

Start date: February 2004
Phase: Phase 2
Study type: Interventional

This study serves to compare the effectiveness of treating cutaneous leishmaniasis with either intravenous sodium stibogluconate or direct heat therapy using the ThermoMed-TM device.

NCT ID: NCT00876824 Completed - Clinical trials for Leishmaniasis, Visceral

To Study the Effect Of Single Infusions Of Amphotericin B Lipid Preparations in Treatment of Patients Of Kala Azar

Start date: July 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether a single bolus of dose of Amphoterin B lipid emulsion (Amphomul) is as efficacious and safe compared to a single dose Liposomal Amphotericin B in treating patients with Indian Visceral Leishmaniasis (Kala Azar).