Document Detail


A randomised, double-blind comparison of 20 units of onabotulinumtoxinA with 30 units of incobotulinumtoxinA for glabellar lines.
MedLine Citation:
PMID:  23057624     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Biological activity data indicate that the units of incobotulinumtoxinA are not equivalent to those of onabotulinumtoxinA.
OBJECTIVE: This study compared 20 units of onabotulinumtoxinA with 30 units of incobotulinumtoxinA in the treatment of glabellar lines.
METHODS AND MATERIALS: In this multicenter, randomised, double-blind study, subjects with moderate or severe glabellar lines received a single treatment with 20 units of onabotulinumtoxinA (n = 112), or 30 units of incobotulinumtoxinA (n = 112). The primary endpoint was the percentage of subjects with a reduction of ≥ 1 point on the Facial Wrinkle Scale at maximum contraction as rated by injectors on day 28 post injection. The same variable was evaluated on days 84, 98, and 112.
RESULTS: At the primary endpoint, 20 units of onabotulinumtoxinA was as effective as 30 units of incobotulinumtoxinA (96% vs. 95% responders, respectively; difference in proportion of responders = 0.02, 95% confidence interval [CI] - 0.04, 0.07). At subsequent time points, a trend towards a higher percentage of responders was observed in the group treated with 20 units of onabotulinumtoxinA. Given that the 95% CI surpassed the upper equivalence margin at these time points, equivalence was not established.
CONCLUSION: These data support the non-interchangeability of units of onabotulinumtoxinA and incobotulinumtoxinA, and the absence of a fixed dose ratio in clinical practice.
Authors:
Marion Moers-Carpi; Thomas Dirschka; Gabrielle Feller-Heppt; Said Hilton; Klaus Hoffmann; Wolfgang G Philipp-Dormston; Anita Rütter; Kelvin Tan; Mary Ann Chapman; Antony Fulford-Smith
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2012-11-15
Journal Detail:
Title:  Journal of cosmetic and laser therapy : official publication of the European Society for Laser Dermatology     Volume:  14     ISSN:  1476-4180     ISO Abbreviation:  J Cosmet Laser Ther     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-11     Completed Date:  2013-05-24     Revised Date:  2014-07-31    
Medline Journal Info:
Nlm Unique ID:  101136419     Medline TA:  J Cosmet Laser Ther     Country:  England    
Other Details:
Languages:  eng     Pagination:  296-303     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Botulinum Toxins, Type A / administration & dosage*,  therapeutic use
Confidence Intervals
Double-Blind Method
Female
Forehead
Humans
Male
Middle Aged
Neuromuscular Agents / administration & dosage*,  therapeutic use
Severity of Illness Index
Skin Aging / drug effects*
Time Factors
Young Adult
Chemical
Reg. No./Substance:
0/Neuromuscular Agents; 0/incobotulinumtoxinA; 0/onabotulinumtoxinA; EC 3.4.24.69/Botulinum Toxins, Type A

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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