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

NCT00317629 | Terminated Phase 3 DMC

• 2 other identifiers: fcv1376566-04-18090
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cutaneous Leishmaniasis

Keywords

leishmaniasis; nitric oxide; treatment; donor; controlled trial

Outcome Measures

Primary Outcomes (1)

• Complete reepithelization

  three months after the beginning of the treatment

Secondary Outcomes (1)

• Absence of reactivation and affections of the mucous membranes

  during the first 6 months of the study

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: meglumine antimoniate

2

EXPERIMENTAL

Drug: controlled nitric oxide releasing patch

Interventions

controlled nitric oxide releasing patch DRUG

daily nitric oxide patch application during 20 days

2

meglumine antimoniate DRUG

20mg/kg daily during 20 days

Also known as: glucantime

1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Cardiovascular de Colombia: lead
• Universidad de Antioquia: collaborator
• The University of Akron: collaborator
• Universidad de Santander: collaborator
• Secretaria de Salud de Santander: collaborator
• Secretaria de Salud de Tolima: collaborator

Study Sites (1)

Fundación Cardiovascular de Colombia

Floridablanca, Santander Department, 10000, Colombia

Location

MeSH Terms

Conditions

Leishmaniasis, Cutaneous; Leishmaniasis

Interventions

Meglumine Antimoniate

Condition Hierarchy (Ancestors)

Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Meglumine; Sorbitol; Sugar Alcohols; Alcohols; Organic Chemicals; Hexosamines; Amino Sugars; Carbohydrates

Study Officials

• Patricio López-Jaramillo, MD, PhD

  Cardiovascular Foundation of Colombia

  PRINCIPAL INVESTIGATOR

• Daniel J Smith, PhD

  Akron University

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

• Daniel Smith, PhD

  The University of Akron

  PRINCIPAL INVESTIGATOR

• Ligia C Rueda, MD

  Fundación Cardiovascular de Colombia

  STUDY CHAIR

• Christian F Rueda-Clausen, MD

  Fundación Cardiovascular de Colombia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 21, 2006
• First Posted: April 25, 2006
• Study Start: May 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: March 1, 2009
• Last Updated: November 24, 2010

Record last verified: 2010-11

Locations

CO (1)