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.

Disclosures

Did you receive any funding to support your research for this TOPIC?
Yes
Please specify entities (individual, company, society): The study was funded by Evolus Inc

Were you provided with any honoraria, payment or other compensation for your work on this study?
No

Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
Yes
Please specify entities (individual, company, society): Shareholder in Stratsphey Crown indirect interest in th study product in the US

Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
No

This work is presented thanks to the support of: Daewoong Co , South Korea

Disclosures

Did you receive any funding to support your research for this TOPIC?
No

Were you provided with any honoraria, payment or other compensation for your work on this study?
Yes
Please specify entities (individual, company, society): Daewoong

Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
No

Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
No

This work is presented thanks to the support of: Daewoong