Efficacy of Topical Liposomal Form of Drugs in Cutaneous Leishmaniasis

Tehran University of Medical Sciences

Status and phase: Completed; Early Phase 1

Conditions: Cutaneous Leishmaniasis

Treatments: Drug: Liposomal Paromomycin; Drug: Liposomal meglumine antimoniate; Drug: Liposomal meglumine antimoniate (Glucantime); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01050777

86783

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 12 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups, including a placebo group

Liposomal Paromomycin

Experimental group

Description:

Liposomes containing 10% Paromomycin

Treatment:

Drug: Liposomal Paromomycin

Drug: Liposomal meglumine antimoniate

Liposomal meglumine antimoniate

Experimental group

Description:

Liposomes containing meglumine antimonate

Treatment:

Drug: Liposomal meglumine antimoniate

Drug: Liposomal meglumine antimoniate (Glucantime)

Placebo

Placebo Comparator group

Treatment:

Drug: Liposomal meglumine antimoniate

Drug: Placebo