Efficacy of Topical Liposomal Form of Drugs in Cutaneous Leishmaniasis

This study has been completed.
Sponsor:
Collaborators:
Mashhad University of Medical Sciences
Center for Research and Training in Skin Diseases and Leprosy
Information provided by (Responsible Party):
Ali Khamesipour, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01050777
First received: January 13, 2010
Last updated: June 19, 2012
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Cutaneous Leishmaniasis
Drug: Liposomal meglumine antimoniate (Glucantime)
Drug: Liposomal meglumine antimoniate
Drug: Liposomal Paromomycin
Drug: Placebo
Phase 0

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

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Complete cure equal to Complete Re-epithelization of all lesions [ Time Frame: 200 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: March 2011
Study Completion Date: March 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liposomal Paromomycin
Liposomes containing 10% Paromomycin
Drug: Liposomal meglumine antimoniate
Liposomal form of meglumine antimoniate
Drug: Liposomal Paromomycin
Liposomal form of 10% Paromomycin
Experimental: Liposomal meglumine antimoniate
Liposomes containing meglumine antimonate
Drug: Liposomal meglumine antimoniate (Glucantime)
Liposomes containing meglumine antimoniate
Drug: Liposomal meglumine antimoniate
Liposomal form of meglumine antimoniate
Placebo Comparator: Placebo Drug: Liposomal meglumine antimoniate
Liposomal form of meglumine antimoniate
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   12 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01050777

Locations
Iran, Islamic Republic of
Emam Reza Hospital
Mashhad, Khorasan Razavi, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Mashhad University of Medical Sciences
Center for Research and Training in Skin Diseases and Leprosy
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Ali Khamesipour, PhD, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01050777     History of Changes
Other Study ID Numbers: 86783
Study First Received: January 13, 2010
Last Updated: June 19, 2012
Health Authority: Iran: Ministry of Health & Medical Education
Iran: Ethics Committee

Keywords provided by Tehran University of Medical Sciences:
Cutaneous Leishmaniasis caused by l. tropica

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Paromomycin
Meglumine antimoniate
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 17, 2014