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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:  Publisher    
Abstract Background Biological activity data indicate that 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 at day 28 postinjection. The same variable was evaluated at 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 toward 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.
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:  JOURNAL ARTICLE     Date:  2012-10-11
Journal Detail:
Title:  Journal of cosmetic and laser therapy : official publication of the European Society for Laser Dermatology     Volume:  -     ISSN:  1476-4180     ISO Abbreviation:  J Cosmet Laser Ther     Publication Date:  2012 Oct 
Date Detail:
Created Date:  2012-10-12     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101136419     Medline TA:  J Cosmet Laser Ther     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
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