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
- Authors
- Han, H.S.; Yoo, K.H.; Lee, J.S.; Huh, C.-H.; Kwon, S.-H.; Lee, Y.W.; Kim, Beom Joon
- Issue Date
- Apr-2021
- Publisher
- NLM (Medline)
- Citation
- Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.], v.47, no.4, pp e127 - e131
- Journal Title
- Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]
- Volume
- 47
- Number
- 4
- Start Page
- e127
- End Page
- e131
- URI
- https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/48002
- DOI
- 10.1097/DSS.0000000000002807
- ISSN
- 1076-0512
1524-4725
- 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.
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