Estudo clínico randomizado, aberto e comparativo para avaliação de segurança, tolerabilidade e eficácia analgésica de duas diferentes apresentações de medicamento tópico na realização de curetagem dermatológica de molusco contagioso em pacientes pediátricos
Autor(a) principal: | |
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Data de Publicação: | 2010 |
Outros Autores: | , , , , |
Tipo de documento: | Artigo |
Idioma: | por |
Título da fonte: | Repositório Institucional da UNESP |
Texto Completo: | http://www.moreirajr.com.br/revistas.asp?fase=r003&id_materia=4320 http://hdl.handle.net/11449/71714 |
Resumo: | Aim: This study aimed to compare the safety and analgesic efficacy of a new topical drug (in two different presentations: cream and aerosol) consisting of benzocaine, menthol and triclosan, in the curettage of molluscum contagiosum. Method: The study included 296 volunteers in different stages: 256 healthy adult volunteers for the safety evaluation, and 40 volunteers between 2 and 12 years old who presented Molluscum contagiosum, for the evaluation of tolerability and efficacy. Each volunteer represented two experimental units (left and right) where it was applied randomly the tested products (cream or aerosol) 30 minutes before the dermatological curettage, immediately after and twice a day during 7 days. Dermatological evaluations of safety and efficacy were performed immediately after the procedure, 3 and 7 days after the curettage. Results: During safety evaluation, the tested products showed no irritant, sensitizing, phototoxic or photosensitizing potential. Both presentations, cream and aerosol, were considered safe with no statistically significant differences between them. With respect to analgesic efficacy, the results showed that the medication promoted the reduction of painful symptoms and there was no statistically significant difference (p <0.05) between the two presentations. Conclusion: The tested product, in two different presentations, was considered safe and effective in controlling pain symptoms during and after the curettage of molluscum contagiosum. © Copyright Moreira Jr. Editora. |
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Estudo clínico randomizado, aberto e comparativo para avaliação de segurança, tolerabilidade e eficácia analgésica de duas diferentes apresentações de medicamento tópico na realização de curetagem dermatológica de molusco contagioso em pacientes pediátricosA randomized, open-label, comparative clinical study for the evaluation of safety, tolerability and analgesic efficacy of two different presentations of topical medication in the treatment of dermatological curettage of molluscum contagiosum in pediatric patientsCurettageLocal anesthesiaMolluscum contagiosumanalgesic agentbenzocainebenzocaine plus menthol plus triclosanef 028mentholtriclosanunclassified druganalgesic activitychildchildhood diseaseclinical trialcontrolled clinical trialcontrolled studydrug dosage form comparisondrug efficacydrug formulationdrug mechanismdrug safetydrug tolerabilityhumanmajor clinical studymolluscum contagiosumopen studyphotosensitizationphototoxicitypostoperative painpreschool childrandomized controlled trialschool childside effectskin irritationskin sensitizationskin surgerytreatment durationAim: This study aimed to compare the safety and analgesic efficacy of a new topical drug (in two different presentations: cream and aerosol) consisting of benzocaine, menthol and triclosan, in the curettage of molluscum contagiosum. Method: The study included 296 volunteers in different stages: 256 healthy adult volunteers for the safety evaluation, and 40 volunteers between 2 and 12 years old who presented Molluscum contagiosum, for the evaluation of tolerability and efficacy. Each volunteer represented two experimental units (left and right) where it was applied randomly the tested products (cream or aerosol) 30 minutes before the dermatological curettage, immediately after and twice a day during 7 days. Dermatological evaluations of safety and efficacy were performed immediately after the procedure, 3 and 7 days after the curettage. Results: During safety evaluation, the tested products showed no irritant, sensitizing, phototoxic or photosensitizing potential. Both presentations, cream and aerosol, were considered safe with no statistically significant differences between them. With respect to analgesic efficacy, the results showed that the medication promoted the reduction of painful symptoms and there was no statistically significant difference (p <0.05) between the two presentations. Conclusion: The tested product, in two different presentations, was considered safe and effective in controlling pain symptoms during and after the curettage of molluscum contagiosum. © Copyright Moreira Jr. Editora.FMUSPDermatologie UNISAMedcin Instituto da Pele Ltda.Farmacêutica Bioquímica - UNESP-SPFarmacêutica Industrial - PUC-RSGerontologia Biomédica - PUC-RSEurofarma Laboratórios Ltda.Biomédica - UNESP-SPUSP-SPFarmacêutica Bioquímica - UNESP-SPBiomédica - UNESP-SPUniversidade de São Paulo (USP)UNISAMedcin Instituto da Pele Ltda.Universidade Estadual Paulista (Unesp)Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS)Eurofarma Laboratórios Ltda.Schalka, SérgioAddor, Flávia Alvim Sant'AnnaSilva, Vanessa de Melo [UNESP]Pinto, Patrícia Camarano [UNESP]Milan, Ana Lúcia KoffPannuti, Estela Maia Bellini [UNESP]2014-05-27T11:24:42Z2014-05-27T11:24:42Z2010-06-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article201-207http://www.moreirajr.com.br/revistas.asp?fase=r003&id_materia=4320Revista Brasileira de Medicina, v. 67, n. 6, p. 201-207, 2010.0034-7264http://hdl.handle.net/11449/717142-s2.0-77954911779Scopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPporRevista Brasileira de Medicina0,101info:eu-repo/semantics/openAccess2021-10-23T11:39:05Zoai:repositorio.unesp.br:11449/71714Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-08-05T22:49:33.638737Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false |
dc.title.none.fl_str_mv |
Estudo clínico randomizado, aberto e comparativo para avaliação de segurança, tolerabilidade e eficácia analgésica de duas diferentes apresentações de medicamento tópico na realização de curetagem dermatológica de molusco contagioso em pacientes pediátricos A randomized, open-label, comparative clinical study for the evaluation of safety, tolerability and analgesic efficacy of two different presentations of topical medication in the treatment of dermatological curettage of molluscum contagiosum in pediatric patients |
title |
Estudo clínico randomizado, aberto e comparativo para avaliação de segurança, tolerabilidade e eficácia analgésica de duas diferentes apresentações de medicamento tópico na realização de curetagem dermatológica de molusco contagioso em pacientes pediátricos |
spellingShingle |
Estudo clínico randomizado, aberto e comparativo para avaliação de segurança, tolerabilidade e eficácia analgésica de duas diferentes apresentações de medicamento tópico na realização de curetagem dermatológica de molusco contagioso em pacientes pediátricos Schalka, Sérgio Curettage Local anesthesia Molluscum contagiosum analgesic agent benzocaine benzocaine plus menthol plus triclosan ef 028 menthol triclosan unclassified drug analgesic activity child childhood disease clinical trial controlled clinical trial controlled study drug dosage form comparison drug efficacy drug formulation drug mechanism drug safety drug tolerability human major clinical study molluscum contagiosum open study photosensitization phototoxicity postoperative pain preschool child randomized controlled trial school child side effect skin irritation skin sensitization skin surgery treatment duration |
title_short |
Estudo clínico randomizado, aberto e comparativo para avaliação de segurança, tolerabilidade e eficácia analgésica de duas diferentes apresentações de medicamento tópico na realização de curetagem dermatológica de molusco contagioso em pacientes pediátricos |
title_full |
Estudo clínico randomizado, aberto e comparativo para avaliação de segurança, tolerabilidade e eficácia analgésica de duas diferentes apresentações de medicamento tópico na realização de curetagem dermatológica de molusco contagioso em pacientes pediátricos |
title_fullStr |
Estudo clínico randomizado, aberto e comparativo para avaliação de segurança, tolerabilidade e eficácia analgésica de duas diferentes apresentações de medicamento tópico na realização de curetagem dermatológica de molusco contagioso em pacientes pediátricos |
title_full_unstemmed |
Estudo clínico randomizado, aberto e comparativo para avaliação de segurança, tolerabilidade e eficácia analgésica de duas diferentes apresentações de medicamento tópico na realização de curetagem dermatológica de molusco contagioso em pacientes pediátricos |
title_sort |
Estudo clínico randomizado, aberto e comparativo para avaliação de segurança, tolerabilidade e eficácia analgésica de duas diferentes apresentações de medicamento tópico na realização de curetagem dermatológica de molusco contagioso em pacientes pediátricos |
author |
Schalka, Sérgio |
author_facet |
Schalka, Sérgio Addor, Flávia Alvim Sant'Anna Silva, Vanessa de Melo [UNESP] Pinto, Patrícia Camarano [UNESP] Milan, Ana Lúcia Koff Pannuti, Estela Maia Bellini [UNESP] |
author_role |
author |
author2 |
Addor, Flávia Alvim Sant'Anna Silva, Vanessa de Melo [UNESP] Pinto, Patrícia Camarano [UNESP] Milan, Ana Lúcia Koff Pannuti, Estela Maia Bellini [UNESP] |
author2_role |
author author author author author |
dc.contributor.none.fl_str_mv |
Universidade de São Paulo (USP) UNISA Medcin Instituto da Pele Ltda. Universidade Estadual Paulista (Unesp) Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS) Eurofarma Laboratórios Ltda. |
dc.contributor.author.fl_str_mv |
Schalka, Sérgio Addor, Flávia Alvim Sant'Anna Silva, Vanessa de Melo [UNESP] Pinto, Patrícia Camarano [UNESP] Milan, Ana Lúcia Koff Pannuti, Estela Maia Bellini [UNESP] |
dc.subject.por.fl_str_mv |
Curettage Local anesthesia Molluscum contagiosum analgesic agent benzocaine benzocaine plus menthol plus triclosan ef 028 menthol triclosan unclassified drug analgesic activity child childhood disease clinical trial controlled clinical trial controlled study drug dosage form comparison drug efficacy drug formulation drug mechanism drug safety drug tolerability human major clinical study molluscum contagiosum open study photosensitization phototoxicity postoperative pain preschool child randomized controlled trial school child side effect skin irritation skin sensitization skin surgery treatment duration |
topic |
Curettage Local anesthesia Molluscum contagiosum analgesic agent benzocaine benzocaine plus menthol plus triclosan ef 028 menthol triclosan unclassified drug analgesic activity child childhood disease clinical trial controlled clinical trial controlled study drug dosage form comparison drug efficacy drug formulation drug mechanism drug safety drug tolerability human major clinical study molluscum contagiosum open study photosensitization phototoxicity postoperative pain preschool child randomized controlled trial school child side effect skin irritation skin sensitization skin surgery treatment duration |
description |
Aim: This study aimed to compare the safety and analgesic efficacy of a new topical drug (in two different presentations: cream and aerosol) consisting of benzocaine, menthol and triclosan, in the curettage of molluscum contagiosum. Method: The study included 296 volunteers in different stages: 256 healthy adult volunteers for the safety evaluation, and 40 volunteers between 2 and 12 years old who presented Molluscum contagiosum, for the evaluation of tolerability and efficacy. Each volunteer represented two experimental units (left and right) where it was applied randomly the tested products (cream or aerosol) 30 minutes before the dermatological curettage, immediately after and twice a day during 7 days. Dermatological evaluations of safety and efficacy were performed immediately after the procedure, 3 and 7 days after the curettage. Results: During safety evaluation, the tested products showed no irritant, sensitizing, phototoxic or photosensitizing potential. Both presentations, cream and aerosol, were considered safe with no statistically significant differences between them. With respect to analgesic efficacy, the results showed that the medication promoted the reduction of painful symptoms and there was no statistically significant difference (p <0.05) between the two presentations. Conclusion: The tested product, in two different presentations, was considered safe and effective in controlling pain symptoms during and after the curettage of molluscum contagiosum. © Copyright Moreira Jr. Editora. |
publishDate |
2010 |
dc.date.none.fl_str_mv |
2010-06-01 2014-05-27T11:24:42Z 2014-05-27T11:24:42Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://www.moreirajr.com.br/revistas.asp?fase=r003&id_materia=4320 Revista Brasileira de Medicina, v. 67, n. 6, p. 201-207, 2010. 0034-7264 http://hdl.handle.net/11449/71714 2-s2.0-77954911779 |
url |
http://www.moreirajr.com.br/revistas.asp?fase=r003&id_materia=4320 http://hdl.handle.net/11449/71714 |
identifier_str_mv |
Revista Brasileira de Medicina, v. 67, n. 6, p. 201-207, 2010. 0034-7264 2-s2.0-77954911779 |
dc.language.iso.fl_str_mv |
por |
language |
por |
dc.relation.none.fl_str_mv |
Revista Brasileira de Medicina 0,101 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
201-207 |
dc.source.none.fl_str_mv |
Scopus reponame:Repositório Institucional da UNESP instname:Universidade Estadual Paulista (UNESP) instacron:UNESP |
instname_str |
Universidade Estadual Paulista (UNESP) |
instacron_str |
UNESP |
institution |
UNESP |
reponame_str |
Repositório Institucional da UNESP |
collection |
Repositório Institucional da UNESP |
repository.name.fl_str_mv |
Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP) |
repository.mail.fl_str_mv |
|
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1808129466309804032 |