PMID- 33481449
OWN - NLM
STAT- MEDLINE
DCOM- 20210817
LR  - 20210817
IS  - 1524-4725 (Electronic)
IS  - 1076-0512 (Linking)
VI  - 47
IP  - 3
DP  - 2021 Mar 1
TI  - Efficacy and Safety of a New Botulinum Toxin (HU-014) Versus Existing 
      Onabotulinumtoxin A in Subjects With Moderate to Severe Glabellar Lines.
PG  - e91-e96
LID - 10.1097/DSS.0000000000002789 [doi]
AB  - BACKGROUND: Recently, the safety of a new botulinum toxin (HU-014) was confirmed 
      through animal experiments. The evaluation of the efficacy and safety of this 
      newly introduced botulinum toxin is required considering the risk of adverse 
      events (AEs) and need for standardization before its universal use. OBJECTIVE: 
      The aim of this multicenter, double-blind, randomized, parallel, 
      active-controlled phase III clinical trial was to investigate the noninferiority 
      of HU-014 versus existing onabotulinumtoxin A for the treatment of moderate to 
      severe glabellar lines. METHODS: In total, 267 subjects were randomized to either 
      the test (HU-014) or control (onabotulinumtoxin A) group. At the baseline and at 
      weeks 4, 8, 12, and 16, investigator's live assessment, independent photographic 
      assessment, subjects' improvement assessment, subjects' satisfaction assessment, 
      and safety assessment were performed. RESULTS: At week 4, the response rate was 
      90.15% and 92.31% in the test and control groups, respectively, as per 
      investigator's live assessment while frowning, without a significant difference. 
      Both groups also showed no significant differences in response rates in the other 
      assessments. In addition, no serious AEs were reported. CONCLUSION: HU-014 was 
      noninferior to existing onabotulinumtoxin A in the treatment of glabellar lines 
      at a 1:1 dose ratio, and both products were well tolerated.
CI  - Copyright (c) 2020 by the American Society for Dermatologic Surgery, Inc. Published 
      by Wolters Kluwer Health, Inc. All rights reserved.
FAU - Yoo, Kwang Ho
AU  - Yoo KH
AD  - Department of Dermatology, College of Medicine, Chung-Ang University Hospital, 
      Seoul, Korea.
FAU - Lee, Yang Won
AU  - Lee YW
AD  - Department of Dermatology, College of Medicine, Konkuk University Hospital, 
      Seoul, Korea.
FAU - Lee, Ji Su
AU  - Lee JS
AD  - Department of Dermatology, College of Medicine, Konkuk University Hospital, 
      Seoul, Korea.
FAU - Kwon, Soon Hyo
AU  - Kwon SH
AD  - Department of Dermatology, College of Medicine, Kyung Hee University Hospital at 
      Gangdong, Seoul, Korea.
FAU - Huh, Chang Hun
AU  - Huh CH
AD  - Department of Dermatology, College of Medicine, Seoul National University Bundang 
      Hospital, Seongnam, South Korea.
FAU - Kim, Beom Joon
AU  - Kim BJ
AD  - Department of Dermatology, College of Medicine, Chung-Ang University Hospital, 
      Seoul, Korea.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Dermatol Surg
JT  - Dermatologic surgery : official publication for American Society for Dermatologic 
      Surgery [et al.]
JID - 9504371
RN  - 0 (Neuromuscular Agents)
RN  - EC 3.4.24.69 (Botulinum Toxins, Type A)
RN  - EC 3.4.24.69 (onabotulinum toxin A)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Botulinum Toxins, Type A/*administration & dosage/adverse effects
MH  - *Cosmetic Techniques
MH  - Double-Blind Method
MH  - Face
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neuromuscular Agents/*administration & dosage/adverse effects
MH  - Skin Aging/*drug effects
MH  - Young Adult
EDAT- 2021/01/23 06:00
MHDA- 2021/08/18 06:00
CRDT- 2021/01/22 13:42
PHST- 2021/01/23 06:00 [pubmed]
PHST- 2021/08/18 06:00 [medline]
PHST- 2021/01/22 13:42 [entrez]
AID - 00042728-900000000-97654 [pii]
AID - 10.1097/DSS.0000000000002789 [doi]
PST - ppublish
SO  - Dermatol Surg. 2021 Mar 1;47(3):e91-e96. doi: 10.1097/DSS.0000000000002789.