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.
Declaraciones
¿Ha recibido algún tipo de financiamiento para realizar su investigación sobre esta temática?
Si
Por favor especifique las entidades (individuo, empresa, sociedad): The study was funded by Evolus Inc
¿Ha recibido algún pago, honorario u otra compensación por su trabajo acerca de esta investigación?
No
¿Tiene vínculos financieros con alguna entidad que podría llegar a competir estrechamente con los medicamentos, materiales o instrumentos tratados en su investigación?
Si
Por favor especifique las entidades (individuo, empresa, sociedad): Shareholder in Stratsphey Crown indirect interest in th study product in the US
¿Posee o ha solicitado una patente relacionada a los materiales, productos o instrumentos utilizados en su investigación?
No
Este trabajo es presentado gracias al apoyo de: Daewoong Co , South Korea