Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis
Status:
Terminated
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Fundación Cardiovascular de Colombia
Collaborators:
Secretaria de Salud de Santander Secretaria de Salud de Tolima The University of Akron Universidad de Antioquia Universidad de Santander