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

This study has been terminated.
(An interim analysis showed that nitric oxide patches are not enough effective)
Sponsor:
Collaborators:
Universidad de Antioquia
The University of Akron
Universidad de Santander
Secretaria de Salud de Santander
Secretaria de Salud de Tolima
Information provided by:
Fundación Cardiovascular de Colombia
ClinicalTrials.gov Identifier:
NCT00317629
First received: April 21, 2006
Last updated: November 23, 2010
Last verified: November 2010
  Purpose

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
Cutaneous Leishmaniasis
Drug: controlled nitric oxide releasing patch
Drug: meglumine antimoniate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Fundación Cardiovascular de Colombia:

Primary Outcome Measures:
  • Complete reepithelization [ Time Frame: three months after the beginning of the treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absence of reactivation and affections of the mucous membranes [ Time Frame: during the first 6 months of the study ] [ Designated as safety issue: Yes ]

Enrollment: 178
Study Start Date: May 2006
Study Completion Date: March 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: meglumine antimoniate
20mg/kg daily during 20 days
Other Name: glucantime
Experimental: 2 Drug: controlled nitric oxide releasing patch
daily nitric oxide patch application during 20 days

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317629

Locations
Colombia
Fundación Cardiovascular de Colombia
Floridablanca, Santander, Colombia, 10000
Sponsors and Collaborators
Fundación Cardiovascular de Colombia
Universidad de Antioquia
The University of Akron
Universidad de Santander
Secretaria de Salud de Santander
Secretaria de Salud de Tolima
Investigators
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
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
  More Information

No publications provided

Responsible Party: Victor Raúl Castillo Mantilla, Fundación Cardiovascular de Colombia
ClinicalTrials.gov Identifier: NCT00317629     History of Changes
Other Study ID Numbers: fcv137, 6566-04-18090
Study First Received: April 21, 2006
Last Updated: November 23, 2010
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Fundación Cardiovascular de Colombia:
leishmaniasis
nitric oxide
treatment
donor
controlled trial

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Nitric Oxide
Meglumine antimoniate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 26, 2014