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Efficacy and Safety of Miltefosine or Thermotherapy for Cutaneous Leishmaniasis in Colombia.

NCT00471705 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 437

Last updated 2019-01-16

Study results available
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Summary

Cutaneous leishmaniasis (CL) is a worldwide disease, endemic in 88 countries, that has shown an increasing incidence the last two decades. It is estimated that in 2005, about of 20,000 new cases of CL were diagnosed in Colombia.

So far, pentavalent antimony compounds have been considered the treatment of choice with a percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by their adverse events and disadvantages. Previous studies have shown that miltefosine could be a potential alternative of treatment for CL.

The main objective of this study is to evaluate the efficacy and safety of miltefosine or thermotherapy for the treatment for CL. In this study the efficacy of oral treatment of miltefosine 150 mg/day for 28 days or a thermotherapy device used for one session at 50 celsius degrees during 30 seconds will be compared with the standard treatment of intramuscular injections of 20 mg/Kg/day of pentavalent antimonials (GlucantimeÒ) for 20 days in CL parasitologically proven patients.

This trial will be conducted according to the International approved GCP (Good Clinical Practice) guidelines.

Conditions

  • Cutaneous Leishmaniasis

Interventions

DRUG

Miltefosine

Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.

DEVICE

Thermotherapy

One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.

DRUG

Glucantime®

Glucantime® 20 mg /Kg /day for 20 days (intramuscular)

Sponsors & Collaborators

  • Dirección de Sanidad del Ejército de Colombia (DISAN)

    collaborator UNKNOWN

  • Ministerio de Salud y Protección Social, Colombia

    collaborator UNKNOWN

  • Universidad de Antioquia

    lead OTHER

Principal Investigators

  • Ivan D. Vélez, MD. PhD. · Program for Research and Control in Tropical Diseases - PECET (Director)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2008-08-31
Completion
2009-12-31

Countries

  • Colombia

Study Locations

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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 NCT00471705 on ClinicalTrials.gov