Phase I/III Clinical Trial to Evaluate the Safety and Efficacy of a New Botulinum Toxin (HU-014) Versus OnabotulinumtoxinA in Subjects With Moderate-to-Severe Crow's Feet Lines
DC Field | Value | Language |
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dc.contributor.author | Han, H.S. | - |
dc.contributor.author | Yoo, K.H. | - |
dc.contributor.author | Lee, J.S. | - |
dc.contributor.author | Huh, C.-H. | - |
dc.contributor.author | Kwon, S.-H. | - |
dc.contributor.author | Lee, Y.W. | - |
dc.contributor.author | Kim, Beom Joon | - |
dc.date.accessioned | 2021-07-29T05:40:11Z | - |
dc.date.available | 2021-07-29T05:40:11Z | - |
dc.date.issued | 2021-04 | - |
dc.identifier.issn | 1076-0512 | - |
dc.identifier.issn | 1524-4725 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/48002 | - |
dc.description.abstract | BACKGROUND: HU-014, a newly introduced botulinum toxin type A, has not been investigated for its efficacy and safety in crow's feet line (CFL) treatment. OBJECTIVE: Here, we compared the efficacy and safety of HU-014 and onabotulinumtoxinA in CFL treatment. METHODS: This was a randomized, double-blind, active drug-controlled, multicenter, 16-week, Phase I/III study designed to determine the noninferiority of HU-014 compared with onabotulinumtoxinA in moderate-to-severe CFL treatment. In the Phase III study, 290 subjects were randomized at a 1:1 ratio to receive a single treatment of HU-014 or onabotulinumtoxinA. The primary endpoint was the proportion of subjects achieving Grade 0 or 1 in the facial wrinkle scale on maximum smile at Week 4. RESULTS: The primary endpoint was achieved by 72% of the subjects with HU-014 and onabotulinumtoxinA treatments, supporting the noninferiority of HU-014 compared with onabotulinumtoxinA. All secondary efficacy outcomes were achieved by the subjects. The 2 groups showed no significant differences in the safety analysis. CONCLUSION: HU-014 has noninferior efficacy and safety compared with onabotulinumtoxinA in the treatment of CFL. Copyright © 2020 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved. | - |
dc.language | 영어 | - |
dc.language.iso | ENG | - |
dc.publisher | NLM (Medline) | - |
dc.title | Phase I/III Clinical Trial to Evaluate the Safety and Efficacy of a New Botulinum Toxin (HU-014) Versus OnabotulinumtoxinA in Subjects With Moderate-to-Severe Crow's Feet Lines | - |
dc.type | Article | - |
dc.identifier.doi | 10.1097/DSS.0000000000002807 | - |
dc.identifier.bibliographicCitation | Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.], v.47, no.4, pp e127 - e131 | - |
dc.description.isOpenAccess | N | - |
dc.identifier.wosid | 000658825800005 | - |
dc.identifier.scopusid | 2-s2.0-85103806478 | - |
dc.citation.endPage | e131 | - |
dc.citation.number | 4 | - |
dc.citation.startPage | e127 | - |
dc.citation.title | Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] | - |
dc.citation.volume | 47 | - |
dc.type.docType | Article | - |
dc.publisher.location | 미국 | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | MULTICENTER | - |
dc.relation.journalResearchArea | Dermatology | - |
dc.relation.journalResearchArea | Surgery | - |
dc.relation.journalWebOfScienceCategory | Dermatology | - |
dc.relation.journalWebOfScienceCategory | Surgery | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
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