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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00351520
Recruitment Status : Completed
First Posted : July 13, 2006
Last Update Posted : September 20, 2011
World Health Organization
Information provided by:
Tehran University of Medical Sciences

Brief Summary:
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 or disease Intervention/treatment Phase
Cutaneous Leishmaniasis Drug: Miltefose Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3, Clinical Trials of Drug Against Cutaneous Leishmaniasis
Study Start Date : May 2006
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

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

Secondary Outcome Measures :
  1. Improvement of the lesion(s)

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00351520

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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
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Principal Investigator: Ali Khamesipour Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences
Layout table for additonal information Identifier: NCT00351520    
Other Study ID Numbers: SGS05/97
First Posted: July 13, 2006    Key Record Dates
Last Update Posted: September 20, 2011
Last Verified: September 2011
Keywords provided by Tehran University of Medical Sciences:
Anthoponotic Cutaneous leishmaniasis
Additional relevant MeSH terms:
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Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Vector Borne Diseases
Skin Diseases, Infectious
Skin Diseases