A clinical toxicology study of a cryotherapic product in healthy male volunteers - doi:10.5020/18061230.2005.p57
Autor(a) principal: | |
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Data de Publicação: | 2012 |
Outros Autores: | , , , , |
Tipo de documento: | Artigo |
Idioma: | por |
Título da fonte: | Revista Brasileira em Promoção da Saúde |
Texto Completo: | https://ojs.unifor.br/RBPS/article/view/906 |
Resumo: | Gelomed® is a frozen emulsion consisting of methyl salicylate, menthol and camphor being indicated on inflammatory processes, especially traumatisms. The association of those active principles promotes a topical anti-inflammatory action explained byvasoconstriction, followed by a reflex vasodilatation response. The study’s outlining consisted of a non-randomized clinical trial with an open bias control. The project was approved by the ethics in research committee of the Federal University of Ceará. Twenty five healthy male volunteers were selected and each one of them received a daily 50g-topical application of Gelomed® for 20min, twice a day, for 14 uninterrupted days. The volunteers were only included in the study when considered healthy after clinical evaluation, physical tests and laboratorial exams that preceded the study. The evaluations were repeated in the 1st and 2nd weeks and 7 days after the end of the medicine administration. The formulation Gelomed® was well tolerated, however, adverse events were refered by 24% of the volunteers, although only two of those events were related to the formulation (itch and pain in the application site), being all of light intensity and not requiring any further treatment. The clinical exams, physical evaluation and laboratorial tests made before, during and after the research didn’t evidence toxicity signs in the several organs and appraised systems. The phase I clinical trial confirmed the formulation’s safety in the appraised sample, allowing the product to be used in larger populations in the determining of its therapeutic effectiveness. |
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A clinical toxicology study of a cryotherapic product in healthy male volunteers - doi:10.5020/18061230.2005.p57Estudo de toxicologia clínica de um produto crioterápico em voluntários saudáveis do sexo masculino - doi:10.5020/18061230.2005.p57CrioterapiaEnsaios clínicosToxicologia.Gelomed® is a frozen emulsion consisting of methyl salicylate, menthol and camphor being indicated on inflammatory processes, especially traumatisms. The association of those active principles promotes a topical anti-inflammatory action explained byvasoconstriction, followed by a reflex vasodilatation response. The study’s outlining consisted of a non-randomized clinical trial with an open bias control. The project was approved by the ethics in research committee of the Federal University of Ceará. Twenty five healthy male volunteers were selected and each one of them received a daily 50g-topical application of Gelomed® for 20min, twice a day, for 14 uninterrupted days. The volunteers were only included in the study when considered healthy after clinical evaluation, physical tests and laboratorial exams that preceded the study. The evaluations were repeated in the 1st and 2nd weeks and 7 days after the end of the medicine administration. The formulation Gelomed® was well tolerated, however, adverse events were refered by 24% of the volunteers, although only two of those events were related to the formulation (itch and pain in the application site), being all of light intensity and not requiring any further treatment. The clinical exams, physical evaluation and laboratorial tests made before, during and after the research didn’t evidence toxicity signs in the several organs and appraised systems. The phase I clinical trial confirmed the formulation’s safety in the appraised sample, allowing the product to be used in larger populations in the determining of its therapeutic effectiveness.Gelomed® é uma emulsão congelada composta de salicilato de metila, cânfora e mentol com indicação para a terapia de processos inflamatórios, especialmente os determinados por traumatismos. A associação desses princípios ativos promove uma ação antiinflamatória tópica explicada por uma vasoconstrição inicial, seguida de resposta vasodilatadora reflexa. O desenho do estudo foi de um ensaio clínico não randomizado de modalidade de controle “bias” aberto. O projeto foi aprovado pelo comitê de ética em pesquisa da Universidade Federal do Ceará. Foram selecionados 25 voluntários saudáveis do sexo masculino, que receberam topicamente a aplicação de 50g de Gelomed® por 20min, duas vezes ao dia, durante 14 dias ininterruptos. Os voluntários foram incluídos no estudo somente quando considerados saudáveis após avaliação clínica, exame físico e exames laboratoriais que antecederam o estudo. As avaliações foram repetidas na 1ª e 2ª semanas e 7 dias após o fim da administração do medicamento. A formulação Gelomed® foi bem tolerada pelos voluntários, entretanto, eventos adversos foram relatados por 24% dos voluntários, somente dois desses eventos foram relacionados a formulação (prurido e dor no local da aplicação), todos de intensidade leve que cederam sem medicação adicional. Os exames clínicos, eletrocardiográficos e laboratoriais efetuados antes, durante e após o ensaio não evidenciaram sinais de toxicidade nos diversos órgãos e sistemas avaliados. O ensaio clínico de fase I confirmou segurança da formulação na amostra avaliada, permitindo que o produto possa ser empregado em populações maiores para determinação de sua eficácia terapêutica.Universidade de Fortaleza2012-01-04info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed Article""Avaliado pelos pares""Avaliado pelos pares"application/pdfhttps://ojs.unifor.br/RBPS/article/view/90610.5020/906Brazilian Journal in Health Promotion; Vol. 18 No. 2 (2005); 57-63Revista Brasileña en Promoción de la Salud; Vol. 18 Núm. 2 (2005); 57-63Revista Brasileira em Promoção da Saúde; v. 18 n. 2 (2005); 57-631806-1230reponame:Revista Brasileira em Promoção da Saúdeinstname:Universidade de Fortaleza (Unifor)instacron:UFORporhttps://ojs.unifor.br/RBPS/article/view/906/2086Soares, Aline Kércia AlvesSampaio, Ianna LacerdaFontenele, Luciana SaidBezerra, Fernando Antônio FrotaMoraes, Manoel Odorico deMoraes, Maria Elisabete Amaral deinfo:eu-repo/semantics/openAccess2012-01-10T12:17:36Zoai:ojs.ojs.unifor.br:article/906Revistahttps://periodicos.unifor.br/RBPS/oai1806-12301806-1222opendoar:2012-01-10T12:17:36Revista Brasileira em Promoção da Saúde - Universidade de Fortaleza (Unifor)false |
dc.title.none.fl_str_mv |
A clinical toxicology study of a cryotherapic product in healthy male volunteers - doi:10.5020/18061230.2005.p57 Estudo de toxicologia clínica de um produto crioterápico em voluntários saudáveis do sexo masculino - doi:10.5020/18061230.2005.p57 |
title |
A clinical toxicology study of a cryotherapic product in healthy male volunteers - doi:10.5020/18061230.2005.p57 |
spellingShingle |
A clinical toxicology study of a cryotherapic product in healthy male volunteers - doi:10.5020/18061230.2005.p57 Soares, Aline Kércia Alves Crioterapia Ensaios clínicos Toxicologia. |
title_short |
A clinical toxicology study of a cryotherapic product in healthy male volunteers - doi:10.5020/18061230.2005.p57 |
title_full |
A clinical toxicology study of a cryotherapic product in healthy male volunteers - doi:10.5020/18061230.2005.p57 |
title_fullStr |
A clinical toxicology study of a cryotherapic product in healthy male volunteers - doi:10.5020/18061230.2005.p57 |
title_full_unstemmed |
A clinical toxicology study of a cryotherapic product in healthy male volunteers - doi:10.5020/18061230.2005.p57 |
title_sort |
A clinical toxicology study of a cryotherapic product in healthy male volunteers - doi:10.5020/18061230.2005.p57 |
author |
Soares, Aline Kércia Alves |
author_facet |
Soares, Aline Kércia Alves Sampaio, Ianna Lacerda Fontenele, Luciana Said Bezerra, Fernando Antônio Frota Moraes, Manoel Odorico de Moraes, Maria Elisabete Amaral de |
author_role |
author |
author2 |
Sampaio, Ianna Lacerda Fontenele, Luciana Said Bezerra, Fernando Antônio Frota Moraes, Manoel Odorico de Moraes, Maria Elisabete Amaral de |
author2_role |
author author author author author |
dc.contributor.author.fl_str_mv |
Soares, Aline Kércia Alves Sampaio, Ianna Lacerda Fontenele, Luciana Said Bezerra, Fernando Antônio Frota Moraes, Manoel Odorico de Moraes, Maria Elisabete Amaral de |
dc.subject.por.fl_str_mv |
Crioterapia Ensaios clínicos Toxicologia. |
topic |
Crioterapia Ensaios clínicos Toxicologia. |
description |
Gelomed® is a frozen emulsion consisting of methyl salicylate, menthol and camphor being indicated on inflammatory processes, especially traumatisms. The association of those active principles promotes a topical anti-inflammatory action explained byvasoconstriction, followed by a reflex vasodilatation response. The study’s outlining consisted of a non-randomized clinical trial with an open bias control. The project was approved by the ethics in research committee of the Federal University of Ceará. Twenty five healthy male volunteers were selected and each one of them received a daily 50g-topical application of Gelomed® for 20min, twice a day, for 14 uninterrupted days. The volunteers were only included in the study when considered healthy after clinical evaluation, physical tests and laboratorial exams that preceded the study. The evaluations were repeated in the 1st and 2nd weeks and 7 days after the end of the medicine administration. The formulation Gelomed® was well tolerated, however, adverse events were refered by 24% of the volunteers, although only two of those events were related to the formulation (itch and pain in the application site), being all of light intensity and not requiring any further treatment. The clinical exams, physical evaluation and laboratorial tests made before, during and after the research didn’t evidence toxicity signs in the several organs and appraised systems. The phase I clinical trial confirmed the formulation’s safety in the appraised sample, allowing the product to be used in larger populations in the determining of its therapeutic effectiveness. |
publishDate |
2012 |
dc.date.none.fl_str_mv |
2012-01-04 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion "Peer-reviewed Article" "Avaliado pelos pares" "Avaliado pelos pares" |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://ojs.unifor.br/RBPS/article/view/906 10.5020/906 |
url |
https://ojs.unifor.br/RBPS/article/view/906 |
identifier_str_mv |
10.5020/906 |
dc.language.iso.fl_str_mv |
por |
language |
por |
dc.relation.none.fl_str_mv |
https://ojs.unifor.br/RBPS/article/view/906/2086 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Universidade de Fortaleza |
publisher.none.fl_str_mv |
Universidade de Fortaleza |
dc.source.none.fl_str_mv |
Brazilian Journal in Health Promotion; Vol. 18 No. 2 (2005); 57-63 Revista Brasileña en Promoción de la Salud; Vol. 18 Núm. 2 (2005); 57-63 Revista Brasileira em Promoção da Saúde; v. 18 n. 2 (2005); 57-63 1806-1230 reponame:Revista Brasileira em Promoção da Saúde instname:Universidade de Fortaleza (Unifor) instacron:UFOR |
instname_str |
Universidade de Fortaleza (Unifor) |
instacron_str |
UFOR |
institution |
UFOR |
reponame_str |
Revista Brasileira em Promoção da Saúde |
collection |
Revista Brasileira em Promoção da Saúde |
repository.name.fl_str_mv |
Revista Brasileira em Promoção da Saúde - Universidade de Fortaleza (Unifor) |
repository.mail.fl_str_mv |
|
_version_ |
1808844173368885248 |