Status:
COMPLETED
Reduced Doses of Antimony Plus Ranulocyte Monocyte Colony Stimulating Factor (GM-CSF) for Cutaneous Leishmaniasis
Lead Sponsor:
Hospital Universitário Professor Edgard Santos
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado da Bahia
Conditions:
Cutaneous Leishmaniasis
Eligibility:
All Genders
15-50 years
Phase:
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- Age between 15 and 50 years
- Either gender
- Diagnosis of cutaneous leishmaniasis
- Less than 60 days of disease
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00973128
Start Date
February 1 2004
End Date
May 1 2007
Last Update
September 9 2009
Active Locations (1)
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1
Health Post of Corte de Pedra
Valença, Estado de Bahia, Brazil