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 [NCT00317629]

11 p.

Autores:: Silva, Sandra Y.
Rueda, Ligia C.
López Casillas, Marcos
Vélez, Iván D.
Rueda Clausen, Christian F.
Smith, Daniel J.
Muñoz, Gerardo
Mosquera, Hernando
Silva Sieger, Federico Arturo
Buitrago, Adriana
Díaz, Holger
Lopez-Jaramillo, Patricio

Tipo de recurso:: Article of journal

Fecha de publicación:: 2006

Institución:: Universidad de Santander

Repositorio:: Repositorio Universidad de Santander

Idioma:: eng

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dc.title.eng.fl_str_mv	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 [NCT00317629]
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 [NCT00317629]
spellingShingle	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 [NCT00317629] Nitric oxide releasing patch Meglumine antimoniate Cutaneous leishmaniasis
title_short	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 [NCT00317629]
title_full	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 [NCT00317629]
title_fullStr	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 [NCT00317629]
title_full_unstemmed	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 [NCT00317629]
title_sort	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 [NCT00317629]
dc.creator.fl_str_mv	Silva, Sandra Y. Rueda, Ligia C. López Casillas, Marcos Vélez, Iván D. Rueda Clausen, Christian F. Smith, Daniel J. Muñoz, Gerardo Mosquera, Hernando Silva Sieger, Federico Arturo Buitrago, Adriana Díaz, Holger Lopez-Jaramillo, Patricio
dc.contributor.author.spa.fl_str_mv	Silva, Sandra Y. Rueda, Ligia C. López Casillas, Marcos Vélez, Iván D. Rueda Clausen, Christian F. Smith, Daniel J. Muñoz, Gerardo Mosquera, Hernando Silva Sieger, Federico Arturo Buitrago, Adriana Díaz, Holger Lopez-Jaramillo, Patricio
dc.subject.proposal.eng.fl_str_mv	Nitric oxide releasing patch Meglumine antimoniate Cutaneous leishmaniasis
topic	Nitric oxide releasing patch Meglumine antimoniate Cutaneous leishmaniasis
description	11 p.
publishDate	2006
dc.date.issued.spa.fl_str_mv	2006-05-15
dc.date.accessioned.spa.fl_str_mv	2019-07-08T14:11:39Z
dc.date.available.spa.fl_str_mv	2019-07-08T14:11:39Z
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dc.identifier.doi.spa.fl_str_mv	10.1186/1745-6215-7-14
dc.identifier.issn.spa.fl_str_mv	1745-6215
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dc.language.iso.spa.fl_str_mv	eng
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dc.relation.ispartof.eng.fl_str_mv	Trials
dc.rights.spa.fl_str_mv	Derechos Reservados - Trials, 2006
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institution	Universidad de Santander
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spelling	Silva, Sandra Y.98c3c9b3-f205-4784-a0ab-91530a2613a1-1Rueda, Ligia C.8e5a5167-61a4-4d45-a673-8b74f7113c86-1López Casillas, Marcosd77850e1-b3f1-4c4b-95bd-26c376e92c62-1Vélez, Iván D.f0948041-f131-4e0f-86af-9b2525ee6721-1Rueda Clausen, Christian F.bb29e148-b8c5-43f2-9fc0-4eeebb36706b-1Smith, Daniel J.57234e05-c65f-4eec-b3e4-ca27ac8b4033-1Muñoz, Gerardof933a935-7956-425a-abec-b9c9c2c2febc-1Mosquera, Hernando02e7e140-dd2a-4baa-9f3c-3414e22daa9d-1Silva Sieger, Federico Arturo9cced475-6773-4f4f-b4e7-bbebe82a3e16-1Buitrago, Adriana2dfd7b7a-2a34-44a7-97b1-8a4609944765-1Díaz, Holger82dad6e9-c00a-4d5a-8726-798be4a2170d-1Lopez-Jaramillo, Patricio9a71267b-dcb0-4d31-b37d-2d30be58d4d2-12019-07-08T14:11:39Z2019-07-08T14:11:39Z2006-05-1511 p.Background: 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. Methods and design: 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 medicationswill be daily administered 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 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.application/pdf10.1186/1745-6215-7-141745-6215https://repositorio.udes.edu.co/handle/001/3297engTrialsDerechos Reservados - Trials, 2006info:eu-repo/semantics/openAccessAtribución-NoComercial 4.0 Internacional (CC BY-NC 4.0)https://creativecommons.org/licenses/by-nc/4.0/http://purl.org/coar/access_right/c_abf2https://trialsjournal.biomedcentral.com/track/pdf/10.1186/1745-6215-7-14Nitric oxide releasing patchMeglumine antimoniateCutaneous leishmaniasisDouble blind, randomized controlled trial, to evaluate the effectiveness of a controlled nitric oxide releasing patch versus meglumine antimoniate in the treatment of cutaneous leishmaniasis [NCT00317629]Artículo de revistahttp://purl.org/coar/resource_type/c_6501http://purl.org/coar/resource_type/c_2df8fbb1Textinfo:eu-repo/semantics/articlehttp://purl.org/redcol/resource_type/ARTinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/version/c_970fb48d4fbd8a85PublicationTHUMBNAILDouble blind, randomized controlled trial, to evaluate the effectiveness of a controlled nitric oxide releasing patch versus meglumine antimoniate in the treatment of cutaneous leishmaniasis [NCT00317629].pdf.jpgDouble blind, randomized controlled trial, to evaluate the effectiveness of a controlled nitric oxide releasing patch versus meglumine antimoniate in the treatment of cutaneous leishmaniasis [NCT00317629].pdf.jpgGenerated Thumbnailimage/jpeg1820https://repositorio.udes.edu.co/bitstreams/e7614bf7-bf40-4f1a-babf-2bb7c8c7f493/download01618fb9e4ecda3865337722a5ef946dMD54LICENSElicense.txtlicense.txttext/plain; charset=utf-859https://repositorio.udes.edu.co/bitstreams/ccc070c7-45d1-4580-bd33-4ba4e41e3138/download38d94cf55aa1bf2dac1a736ac45c881cMD52ORIGINALDouble blind, randomized controlled trial, to evaluate the effectiveness of a controlled nitric oxide releasing patch versus meglumine antimoniate in the treatment of cutaneous leishmaniasis [NCT00317629].pdfArtículo Principalapplication/pdf600908https://repositorio.udes.edu.co/bitstreams/200e9a1c-858c-4b8e-ad4b-54bbc8d5d0e3/download4f59b8605945fb25e4043de70b02e3abMD55TEXTDouble blind, randomized controlled trial, to evaluate the effectiveness of a controlled nitric oxide releasing patch versus meglumine antimoniate in the treatment of cutaneous leishmaniasis [NCT00317629].pdf.txtDouble blind, randomized controlled trial, to evaluate the effectiveness of a controlled nitric oxide releasing patch versus meglumine antimoniate in the treatment of cutaneous leishmaniasis [NCT00317629].pdf.txtExtracted texttext/plain50217https://repositorio.udes.edu.co/bitstreams/927651a9-2aff-4ffd-835c-a3874acdd3dd/download558e1abd00058b592986f2e14e6cacdeMD53001/3297oai:repositorio.udes.edu.co:001/32972023-10-10 08:44:30.066https://creativecommons.org/licenses/by-nc/4.0/Derechos Reservados - Trials, 2006https://repositorio.udes.edu.coRepositorio Universidad de Santandersoporte@metabiblioteca.comTGljZW5jaWEgZGUgUHVibGljYWNpw7NuIFVERVMKRGlyZWN0cmljZXMgZGUgVVNPIHkgQUNDRVNPCgo=

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 [NCT00317629]

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