Efficacy Trial on Oral Miltefosine in Comparison With Glucantime in the Treatment of ACL Caused by L. Tropica

This study has been completed.
Sponsor:
Collaborator:
World Health Organization
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00351520
First received: July 12, 2006
Last updated: September 19, 2011
Last verified: September 2011
  Purpose

Cutaneous leishmaniasis is a parasitic skin lesion caused by different species of Leishmania and transmitted by the bite of infected sand flies. Leishmaniasis is exist in 88 countries, pentavalent antimonials (sodium stibogluconate and meglumine antimoniate) have been used as a standard treatment for this disease for last 80 years. Pentavalent antimonials are only available as injectable, which is painful, toxic, not affordable and moreover is not always effective even sometimes with several courses of treatment. Many different modalities are used to treat the disease with little success. Miltefosine is drug and has recently been shown to be effective in the treatment cutaneous leishmaniasis in Colombia. The molecular mechanisms that contribute to this effectiveness are not clearly understood. Only a well designed, randomized clinical trial can precisely evaluate the efficacy of any therapeutic modalities in cutaneous leishmaniasis. In this study the efficacy of oral treatment of miltefosine 2.5 mg per Kg body weight for 4 weeks will be compared with standard treatment of intramuscular injections of 60 mg/kg/day glucantime for 2 weeks in ACL parasitologically proven patients. At 8 weeks after the initiation of the treatment any patient in the group who received miltefosine and has not responded to the treatment will be treated with the standard intramuscular injections of 60 mg/kg/day glucantime for 2 weeks. The clinical trial will be carried out according to the International approved GCP (Good Clinical Practice) guide lines.


Condition Intervention Phase
Cutaneous Leishmaniasis
Drug: Miltefose
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3, Clinical Trials of Drug Against Cutaneous Leishmaniasis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Complete re-epithelization of the lesion(s)

Secondary Outcome Measures:
  • Improvement of the lesion(s)

Enrollment: 148
Study Start Date: May 2006
Study Completion Date: June 2007
  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • Parasitologically proven cases of CL based on positive smear and/or culture
  • Otherwise healthy subjects on the basis of medical history, physical examination and results of blood test (if seemed necessary by the physician)
  • Age 12-60 years
  • Willing to participate in the study and sign the informed consent (by the patient or his/her parent/guardian in case of younger than 18 years).

Exclusion Criteria:

  • Pregnant or lactating women
  • Duration of lesion more than 6 months
  • Number of lesions more than 4
  • Ulcer size greater than 4 cm in their largest diameter
  • History of full course of standard treatment (antimonials)
  • History of allergy to Glucantime
  • Serious systemic illnesses (as judged by the physician)
  • Participation in any drug trials in the last 60 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351520

Locations
Iran, Islamic Republic of
Ali Khamesipour
Bam city, Kerman province, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
World Health Organization
Investigators
Principal Investigator: Ali Khamesipour Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00351520     History of Changes
Other Study ID Numbers: SGS05/97, WHO/EMRO
Study First Received: July 12, 2006
Last Updated: September 19, 2011
Health Authority: Iran: Ethics Committee

Keywords provided by Tehran University of Medical Sciences:
Anthoponotic Cutaneous leishmaniasis
Glucantime
Miltefosine

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

ClinicalTrials.gov processed this record on July 29, 2014