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

NCT00351520 | Completed Phase 3

• 2 other identifiers: SGS05/97WHO/EMRO
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Cutaneous Leishmaniasis

Keywords

Anthoponotic Cutaneous leishmaniasis; Glucantime; Miltefosine

Outcome Measures

Primary Outcomes (1)

• Complete re-epithelization of the lesion(s)

Secondary Outcomes (1)

• Improvement of the lesion(s)

Interventions

Miltefose DRUG

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead
• World Health Organization: collaborator

Study Sites (1)

Ali Khamesipour

Bam, Kerman, Iran

Location

MeSH Terms

Conditions

Leishmaniasis, Cutaneous

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

Study Officials

• Ali Khamesipour

  Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 12, 2006
• First Posted: July 13, 2006
• Study Start: May 1, 2006
• Study Completion: June 1, 2007
• Last Updated: September 20, 2011

Record last verified: 2011-09

Locations

IR (1)