Objectives: Achieve knowledge about the effects of prabotulinumtoxin A

Introduction: A 150-day, multicenter, double-blind, active- and placebo-controlled, single-dose Phase III study has been undertaken in Europe

Materials / method: Adult subjects (n=540) with moderate to severe glabellar lines at maximum frown as assessed by the investigator on the 4-point Glabellar Line Scale (GLS, 0=no lines, 1=mild, 2=moderate, 3=severe) were enrolled. Eligible subjects were randomized 5:5:1 to receive a single treatment (0.1 mL injected into each of 5 glabellar sites) of 20 U prabotulinumtoxinA (n=245), 20 U onabotulinumtoxinA (n=246) or placebo (n=49). PrabotulinumtoxinA and onabotulinumtoxinA were each administered as 4 U/0.1 mL; placebo consisted of 0.9% saline.

Results: Responder rates for the primary efficacy endpoint were 87.2%, 82.8% and 4.2% in the prabotulinumtoxinA, onabotulinumtoxinA and placebo groups, respectively. The tests of superiority versus placebo were highly statistically significant: the absolute differences between prabotulinumtoxinA and placebo groups, and between onabotulinumtoxinA and placebo groups were 83.1% and 78.6%, respectively (both p<0.001). The absolute difference between prabotulinumtoxinA and onabotulinumtoxinA groups was 4.4%; 95% CI (-1.9, 10.8).

Conclusion: A single dose of 20 U prabotulinumtoxinA was effective and non-inferior to 20 U onabotulinumtoxinA for the treatment of moderate to severe glabellar lines. Both treatments were well tolerated.

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请注明名称（个人，公司，学会等等）: The study was funded by Evolus Inc

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请注明名称（个人，公司，学会等等）: Shareholder in Stratsphey Crown indirect interest in th study product in the US

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这项工作的完成感谢以下机构的支持： Daewoong Co , South Korea

利益冲突声明

您有否接受任何资金来支持研究这个主题？
否

您是否接受过关于这项研究的任何酬金或其他报酬？
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请注明名称（个人，公司，学会等等）: Daewoong

你是否和任何与您的研究所涉及的药物，材料或工具有密切联系的实体存在财务关系？
否

你是否拥有或者您已经为您此研究中的工具，药物或材料申请任何专利？
否

这项工作的完成感谢以下机构的支持： Daewoong