Efficacy of Topical Liposomal Form of Drugs in Cutaneous Leishmaniasis

Cutaneous Leishmaniasis Clinical Trial

Official title:

Pilot Study of Efficacy of Topical Nano-liposomal Meglumine Antimoniate (Glucantime) or Paromomycin in Combination With Systemic Glucantime for the Treatment of Anthroponotic Cutaneous Leishmaniasis (ACL) Caused by Leishmania Tropica

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01050777
• Other study ID #: 86783
• 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

Related Conditions & MeSH terms

• Cutaneous Leishmaniasis
• Leishmaniasis
• Leishmaniasis, Cutaneous

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