A clinical toxicology study of a cryotherapic product in healthy male volunteers - doi:10.5020/18061230.2005.p57

Detalhes bibliográficos
Autor(a) principal: Soares, Aline Kércia Alves
Data de Publicação: 2012
Outros Autores: Sampaio, Ianna Lacerda, Fontenele, Luciana Said, Bezerra, Fernando Antônio Frota, Moraes, Manoel Odorico de, Moraes, Maria Elisabete Amaral de
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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spelling 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
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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)
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