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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00317629 |
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Date of registration:
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21/04/2006 |
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Primary sponsor: |
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Public title:
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Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis
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Scientific title:
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Double Blind, Randomized Controlled Trial, to Evaluate the Effectiveness of a Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis |
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Date of first enrolment:
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May 2006 |
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Target sample size:
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178 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00317629 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Colombia
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Contacts
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Name:
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Hernando Mosquera, MD |
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Address:
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Email:
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Affiliation:
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Name:
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Daniel J Smith, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Akron University |
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Name:
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Federico A Silva, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cardiovascular Foundation of Colombia |
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Name:
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Patricio López-Jaramillo, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cardiovascular Foundation of Colombia |
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Name:
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Christian F Rueda-Clausen, MD |
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Address:
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Email:
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Affiliation:
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Fundación Cardiovascular de Colombia |
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Name:
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Ligia C Rueda, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fundación Cardiovascular de Colombia |
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Name:
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Iván D Vélez, MD, MsC, PhD |
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Address:
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Email:
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Affiliation:
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Program for the Study and Control of Tropical Diseases, PECET, Universidad de Antioquia |
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Name:
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Daniel Smith, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The University of Akron |
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Name:
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Marcos López, PhD |
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Address:
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Email:
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Affiliation:
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The University of Akron |
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Name:
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Gerardo Muñoz, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universidad Industrial de Santander |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cutaneous Leishmaniasis
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Intervention(s)
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Drug: controlled nitric oxide releasing patch
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Drug: meglumine antimoniate
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Primary Outcome(s)
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Complete reepithelization
[Time Frame: three months after the beginning of the treatment]
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Secondary Outcome(s)
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Absence of reactivation and affections of the mucous membranes
[Time Frame: during the first 6 months of the study]
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Secondary ID(s)
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6566-04-18090
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fcv137
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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