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Sponsors and Collaborators: |
Fundación Cardiovascular de Colombia Universidad de Antioquia The University of Akron University of Santander Secretaria de Salud de Santander Secretaria de Salud de Tolima |
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Information provided by: | Fundación Cardiovascular de Colombia |
ClinicalTrials.gov Identifier: | NCT00317629 |
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 the treatment of choice, with a percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by their many disadvantages and adverse events. Previous studies have shown nitric oxide to be a potential alternative treatment when administered topically with no serious adverse events. However, due to the unstable nitric oxide release, the topical donors needed to be applied frequently, making the adherence to the treatment difficult. The electrospinning technique has allowed the production of a multilayer transdermal patch that produces a continuous and stable nitric oxide release. The main objective of this study is to evaluate this novel nitric oxide topical donor for the treatment of cutaneous leishmaniasis.
A double-blind, randomized, double-masked, placebo-controlled clinical trial, including 620 patients from endemic areas for leishmaniasis in Colombia was designed to investigate whether this patch is as effective as meglumine antimoniate for the treatment of cutaneous leishmaniasis but with less adverse events. Subjects with ulcers characteristic of cutaneous leishmaniasis will be medically evaluated and laboratory tests and parasitological confirmation performed. After checking the inclusion/exclusion criteria, the patients will be randomly assigned to one of two groups. During 20 days Group 1 will receive simultaneously meglumine antimoniate and placebo of nitric oxide patches while Group 2 will receive placebo of meglumine antimoniate and active nitric oxide patches. During the treatment visits, the medications will be administered daily and the presence of adverse events assessed. During the follow-up, the research group will visit the patients at days 21, 45, 90 and 180. The healing process of the ulcer, the health of the participants, recidivisms and/or reinfection will also be assessed. The evolution of the ulcers will be photographically registered. In the case that the effectiveness of the patches is demonstrated, a novel and safe therapeutic alternative for one of the most important public health problems in many countries will be available to patients.
Condition | Intervention | Phase |
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Cutaneous Leishmaniasis |
Drug: controlled nitric oxide releasing patch Drug: meglumine antimoniate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 620 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: meglumine antimoniate
20mg/kg daily during 20 days
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2: Experimental |
Drug: controlled nitric oxide releasing patch
daily nitric oxide patch application during 20 days
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Patricio López-Jaramillo, MD, PhD | +57-7-639292 ext 331 | jplopezj@fcv.org |
Contact: Ronald G Garcia, MD, PhD | +57-7-6399292 ext 345 | ronaldgarcia@fcv.org |
Colombia, Santander | |
Fundación Cardiovascular de Colombia | Recruiting |
Floridablanca, Santander, Colombia, 10000 |
Principal Investigator: | Patricio López-Jaramillo, MD, PhD | Cardiovascular Foundation of Colombia |
Principal Investigator: | Daniel J Smith, PhD | Akron University |
Study Chair: | Iván D Vélez, MD, MsC, PhD | Program for the Study and Control of Tropical Diseases, PECET, Universidad de Antioquia |
Study Chair: | Gerardo Muñoz, PhD | Universidad Industrial de Santander |
Study Chair: | Hernando Mosquera, MD | Unaffiliated |
Study Chair: | Federico A Silva, MD | Cardiovascular Foundation of Colombia |
Study Chair: | Marcos López, PhD | The University of Akron |
Principal Investigator: | Daniel Smith, PhD | The University of Akron |
Study Chair: | Ligia C Rueda, MD | Fundación Cardiovascular de Colombia |
Study Chair: | Christian F Rueda-Clausen, MD | Fundación Cardiovascular de Colombia |
Responsible Party: | Fundación Cardiovascular de Colombia ( Victor Raúl Castillo Mantilla ) |
Study ID Numbers: | fcv137, 6566-04-18090 |
Study First Received: | April 21, 2006 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00317629 |
Health Authority: | Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos |
leishmaniasis nitric oxide treatment donor controlled trial |
Nitric Oxide Leishmaniasis Protozoan Infections Skin Diseases, Infectious |
Skin Diseases Meglumine antimoniate Parasitic Diseases Leishmaniasis, Cutaneous |
Anti-Infective Agents Respiratory System Agents Antiprotozoal Agents Vasodilator Agents Neurotransmitter Agents Antioxidants Skin Diseases, Parasitic Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Asthmatic Agents Mastigophora Infections |
Cardiovascular Agents Protective Agents Pharmacologic Actions Antiparasitic Agents Autonomic Agents Therapeutic Uses Free Radical Scavengers Endothelium-Dependent Relaxing Factors Sarcomastigophora Infections Peripheral Nervous System Agents Bronchodilator Agents |