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

Study Overview
=================
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.

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

Conditions
-----------------
Cutaneous Leishmaniasis

Intervention / Treatment
-----------------
* Drug: GMCSF plus Antimony reduced dose
* Drug: Meglumine antimoniate


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Group 1: Cutaneous leishmaniasis patients randomized in Corte to receive antimony (20mg/daily for 10 days) plus GM-CSF Treatment: antimony (20mg/daily for 10 days) plus GM-CSF (400 µg, divided in two doses a week apart) | Drug: GMCSF plus Antimony reduced dose<br>* 400 µg, divided in two doses a week apart, antimony (20mg/daily for 10 days)<br>* Other names: Sargramostim;|
| Active Comparator: Group 2<br>Group 2: antimony in standard dose plus saline administered in an identical fashion to the GM-CSF. | Drug: Meglumine antimoniate<br>* 20mg/daily for 20 days<br>* Other names: pentavalent antimony;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate or complete cicatrization of the ulcer |  | 3 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial cure rate or complete cicatrization of the ulcer. |  | 2 months after treatment. |