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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00973128

Acronym

GMCSFSbv

Enrollment

Registered

2009-09-09

Start date

2004-02-29

Completion date

2007-05-31

Last updated

2009-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous Leishmaniasis

Brief 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.

Interventions

DRUGGMCSF plus Antimony reduced dose

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

DRUGMeglumine antimoniate

20mg/daily for 20 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

15 Years to 50 Years

Healthy volunteers

Inclusion criteria

* Age between 15 and 50 years * Either gender * Diagnosis of cutaneous leishmaniasis * Less than 60 days of disease

Exclusion criteria

* Any history of prior anti-leishmania therapy * Negative parasitology (aspirate/smear)or negative Montenegro test * Pregnancy * Age below 15 and above 50 years * Other associated acute or chronic illnesses * History of allergy to GM-CSF and/or antimony * HIV, HTLV-1 infections or diabetes * Administrative reasons: * Lack of ability or willingness to give informed consent (patient and/or parent / legal representative) * Anticipated non-availability for study visits/procedures

Design outcomes

Primary

Measure	Time frame
Cure rate or complete cicatrization of the ulcer	3 months after treatment

Secondary

Measure	Time frame
Initial cure rate or complete cicatrization of the ulcer.	2 months after treatment.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026