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Efficacy and Safety of a Novel Botulinum Toxin Type A Product for the Treatment of Moderate to Severe Glabellar Lines: A Randomized, Double-Blind, Active-Controlled Multicenter Study

Authors
 Chong H. Won  ;  Hyung M. Lee  ;  Woo S. Lee  ;  Hoon Kang  ;  Beom J. Kim  ;  Won S. Kim  ;  Ju H. Lee  ;  Dong H. Lee  ;  Chang H. Huh 
Citation
 DERMATOLOGIC SURGERY, Vol.39(1 Pt 2) : 171-178, 2013 
Journal Title
 DERMATOLOGIC SURGERY 
ISSN
 1076-0512 
Issue Date
2013
MeSH
Adult ; Botulinum Toxins, Type A/adverse effects ; Botulinum Toxins, Type A/therapeutic use* ; Double-Blind Method ; Eyebrows ; Female ; Forehead ; Humans ; Male ; Middle Aged ; Neurotoxins/adverse effects ; Neurotoxins/therapeutic use* ; Patient Satisfaction ; Photography ; Skin Aging/drug effects* ; Time Factors
Keywords
Adult ; Botulinum Toxins, Type A/adverse effects ; Botulinum Toxins, Type A/therapeutic use* ; Double-Blind Method ; Eyebrows ; Female ; Forehead ; Humans ; Male ; Middle Aged ; Neurotoxins/adverse effects ; Neurotoxins/therapeutic use* ; Patient Satisfaction ; Photography ; Skin Aging/drug effects* ; Time Factors
Abstract
BACKGROUND: A new botulinum toxin type A (NBoNT) produced from the same strain of Clostridium botulinum as onabotulinumtoxinA (OBoNT) is widely used in Asia. OBJECTIVES: To compare the efficacy and safety of NBoNT and OBoNT for moderate to severe glabellar wrinkles. METHODS: A double-blind, randomized, active-controlled, phase III study was performed. Three hundred fourteen patients were randomized at a 1:1 ratio to receive 20 U of toxin. The primary end point was the responder rate according to investigator live assessment at maximum frown at week 4. Secondary end points were responder rates according to investigator live assessment with frowning and at rest at weeks 8, 12, and 16, with additional photographic assessment by a panel of blinded raters 4 weeks after injection. Subjective satisfaction scores were also evaluated. RESULTS: Four weeks after treatment, responder rates for maximum frown were 93.7% (133/142) in the NBoNT group and 94.5% (138/146) in the OBoNT group. For secondary end points, there was no significant difference between the two groups for any variable at any time point. Noninferiority of NBoNT was confirmed. There were no serious adverse effects with either toxin. CONCLUSION: NBoNT is equally as effective as OBoNT for the treatment of glabellar frown lines. Both toxins were well tolerated.
Full Text
http://onlinelibrary.wiley.com/doi/10.1111/dsu.12072/abstract
DOI
10.1111/dsu.12072
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Dermatology (피부과학교실) > 1. Journal Papers
Yonsei Authors
Lee, Ju Hee(이주희) ORCID logo https://orcid.org/0000-0002-1739-5956
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/88222
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