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

Cutaneous Leishmaniasis Clinical Trial

Official title: Reduced Doses of Antimony Plus Recombinant Human GM-CSF Compared With Antimony in Standard Doses for Cutaneous Leishmaniasis: a Randomized, Single-blind, Placebo-controlled, Pilot Study

Status Completed

Clinical Trial 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.

Clinical Trial Description

This is a randomized, single blind placebo-controlled study in which the groups were selected from the cases presenting to the health post. The inclusion criteria were: age between 15 and 50 years, of either sex, diagnosis of cutaneous leishmaniasis of less than 60 days. The diagnostic criteria were the presence of a typical single cutaneous ulcer, localized on lower limbs, and a positive delayed type hypersensitivity test (DTH or Montenegro skin test) to Leishmania antigen. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cutaneous Leishmaniasis
• Leishmaniasis
• Leishmaniasis, Cutaneous

• NCT number: NCT00973128
• Study type: Interventional
• Source: Hospital Universitário Professor Edgard Santos
• Status: Completed
• Phase: Phase 2
• Start date: February 2004
• Completion date: May 2007