MedTrace Logo

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

NCT00351520 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2011-09-20

No results posted yet for this study

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

Interventions

DRUG

Miltefose

Sponsors & Collaborators

Principal Investigators

  • Ali Khamesipour · Center for Research & Training in Skin Diseases & Leprosy, Tehran University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Completion
2007-06-30

Countries

  • Iran

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00351520 on ClinicalTrials.gov