Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis

Launched by FUNDACIÓN CARDIOVASCULAR DE COLOMBIA · Apr 21, 2006

Keywords

ClinConnect Summary

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 are at risk of contracting the infection \[2-4\]. In America, 60,000 new cases of CL are reported annually \[5\], being endemic in 20 of its 22 countries and in 2 islands of the Caribbean \[2\]. Currently, CL has affected more than 500 U.S. Army soldiers serving in Iraq \[6\]. In the Andean region, the incidence of Leishmaniasis has been increasing dramatically over the last two decades; reachin...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.