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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01050777
Other study ID # 86783
Secondary ID
Status Completed
Phase Phase 0
First received January 13, 2010
Last updated June 19, 2012
Start date March 2011
Est. completion date March 2012

Study information

Verified date February 2011
Source Tehran University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health & Medical EducationIran: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 60 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care


Intervention

Drug:
Liposomal meglumine antimoniate (Glucantime)
Liposomes containing meglumine antimoniate
Liposomal meglumine antimoniate
Liposomal form of meglumine antimoniate
Liposomal Paromomycin
Liposomal form of 10% Paromomycin
Placebo
Placebo

Locations

Country Name City State
Iran, Islamic Republic of Emam Reza Hospital Mashhad Khorasan Razavi

Sponsors (3)

Lead Sponsor Collaborator
Tehran University of Medical Sciences Center for Research and Training in Skin Diseases and Leprosy, Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete cure equal to Complete Re-epithelization of all lesions 200 days Yes
See also
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