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Reduced Doses of Antimony Plus Ranulocyte Monocyte Colony Stimulating Factor (GM-CSF) for Cutaneous Leishmaniasis

NCT00973128 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2009-09-09

No results posted yet for this study

Summary

The present study was designed as a randomized, single blind, placebo-controlled, study to evaluate the effect of 400 µg of recombinant human GM-CSF applied intralesionally and associated with half of the total dose of antimony in a reduced time schedule (20mgSbV/Kg/d for 10 days) as compared to the full dose of antimony (20mgSbV/Kg/d for 20 days) to treat cutaneous leishmaniasis ulcers.

Conditions

  • Cutaneous Leishmaniasis

Interventions

DRUG

GMCSF plus Antimony reduced dose

400 µg, divided in two doses a week apart, antimony (20mg/daily for 10 days)

DRUG

Meglumine antimoniate

20mg/daily for 20 days

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado da Bahia

    collaborator OTHER

  • Hospital Universitário Professor Edgard Santos

    lead OTHER

Principal Investigators

  • Roque P Almeida, MD, PhD · Hospital Universitário Prof Edgard Santos-UFBA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2006-10-31
Completion
2007-05-31

Countries

  • Brazil

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 NCT00973128 on ClinicalTrials.gov