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.
Divulgação de informações
Você recebeu algum patrocínio para sua pesquisa neste tema?
Sim
Por favor indique a entidade (pessoa ou empresa): The study was funded by Evolus Inc
Você recebeu algum tipo de honorário, pagamento ou outra forma de compensação por seu trabalho neste estudo?
Não
Você possui relação financeira com alguma entidade que possa competir com os medicamentos, materiais ou instrumentos abordados no seu estudo?
Sim
Por favor indique a entidade (pessoa ou empresa): Shareholder in Stratsphey Crown indirect interest in th study product in the US
Você detém ou pediu a registro de patente para algum dos instrumentos, medicamentos ou materiais abordados no seu estudo?
Não
Este trabalho foi realizado com o patrocínio de: Daewoong Co , South Korea