Status:
TERMINATED
Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis
Lead Sponsor:
Fundación Cardiovascular de Colombia
Collaborating Sponsors:
Universidad de Antioquia
The University of Akron
Conditions:
Cutaneous Leishmaniasis
Eligibility:
All Genders
18-50 years
Phase:
PHASE3
Brief Summary
Cutaneous leishmaniasis is a worldwide disease, endemic in 88 countries, that has shown an increasing incidence over the last two decades. So far, pentavalent antimony compounds have been considered t...
Detailed Description
BACKGROUND Cutaneous Leishmaniasis (CL) is a worldwide disease that is endemic in 88 countries \[1\] . It is estimated that 1.5 million people suffer from CL annually and that more than 350 million a...
Eligibility Criteria
Inclusion
- Men and women between 18 and 50 years old
- Cutaneous ulcers of more than two weeks of evolution
- Positive parasitological diagnosis for CL
- Patients that voluntarily agree to participate in the study and sign the informed consent.
- Disposition to attend all the visits punctually (initial, treatment and follow-up)
- Acceptation of not using any other treatment for CL while in the study
Exclusion
- Pregnant women
- Presence of any condition or disease that compromises the patient immunologically (i.e. diabetes, cancer, etc.) or, any other, that, based on the judgment of the researcher, could alter the course of CL.
- Diffuse CL or more than five active lesions.
- Mucocutaneous leishmaniasis (no lesion must be located less than 2 cm from the nasal, uro-genital, and/or anal mucous membranes or from the edge of the lips).
- Visceral leishmaniasis
- Complete or incomplete treatment with antimony compounds in the last three months.
- Patients with history of hepatic, renal or cardiovascular disease.
- Mentally or neurologically disabled patients that are considered not fit to approve their participation in the study.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT00317629
Start Date
May 1 2006
End Date
March 1 2009
Last Update
November 24 2010
Active Locations (1)
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1
Fundación Cardiovascular de Colombia
Floridablanca, Santander Department, Colombia, 10000