Efficacy of Topical Liposomal Form of Drugs in Cutaneous Leishmaniasis

NCT01050777 | Completed Early Phase 1 DMC

• 1 other identifier: 86783
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cutaneous Leishmaniasis

Keywords

Cutaneous Leishmaniasis caused by l. tropica

Outcome Measures

Primary Outcomes (1)

• Complete cure equal to Complete Re-epithelization of all lesions

  200 days

Study Arms (3)

Liposomal Paromomycin

EXPERIMENTAL

Liposomes containing 10% Paromomycin

Drug: Liposomal meglumine antimoniate; Drug: Liposomal Paromomycin

Liposomal meglumine antimoniate

EXPERIMENTAL

Liposomes containing meglumine antimonate

Drug: Liposomal meglumine antimoniate (Glucantime); Drug: Liposomal meglumine antimoniate

Placebo

PLACEBO COMPARATOR

Drug: Liposomal meglumine antimoniate; Drug: Placebo

Interventions

Liposomal meglumine antimoniate (Glucantime) DRUG

Liposomes containing meglumine antimoniate

Liposomal meglumine antimoniate

Liposomal meglumine antimoniate DRUG

Liposomal form of meglumine antimoniate

Liposomal Paromomycin; Liposomal meglumine antimoniate; Placebo

Liposomal Paromomycin DRUG

Liposomal form of 10% Paromomycin

Liposomal Paromomycin

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead
• Mashhad University of Medical Sciences: collaborator
• Center for Research and Training in Skin Diseases and Leprosy: collaborator

Study Sites (1)

Emam Reza Hospital

Mashhad, Khorasan Razavi, Iran

Location

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

Interventions

Meglumine Antimoniate

Condition Hierarchy (Ancestors)

Leishmaniasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Meglumine; Sorbitol; Sugar Alcohols; Alcohols; Organic Chemicals; Hexosamines; Amino Sugars; Carbohydrates

Study Officials

• Masud Maleki, MD

  Mashhad University of Medical Sciences, Mashhad, Iran

  PRINCIPAL INVESTIGATOR

• Ali Khamesipour, MPH, PhD

  Center for Research & Training in Skin Diseases & Leprosy, TUMS

  PRINCIPAL INVESTIGATOR

• Mahmoud Reza Jaafari, Parm D, PhD

  Mashhad University of Medical Sciences, Mashhad, Iran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 15, 2010
• Study Start: March 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: March 1, 2012
• Last Updated: June 20, 2012

Record last verified: 2011-02

Locations

IR (1)