NCT00973128

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Hospital Universitário Professor Edgard Santos · Academic / Other
• Sex: All
• Age: 15 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cutaneous Leishmaniasis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2004-02-01
• Primary completion: 2006-10-01
• Completion: 2007-05-01
• First posted: 2009-09-09
• Last updated: 2009-09-09

Locations

1 site across 1 country: Brazil