Botulinum Toxin Type A for the Treatment of Glabellar Lines in Chinese: A Double-Blind, Randomized, Placebo-Controlled Study

Abstract

A single treatment of 20 U of BoNTA was effective and safe in reducing glabellar lines in Chinese subjects.

OnabotulinumtoxinA treatment of moderate to severe glabellar lines in Chinese subjects after laser therapy: A prospective, open-label, noncomparative study

“…The safety profile of onabotulinumtoxinA was similar between the current study and the pivotal study (15).…”

“…In studies of botulinum toxin in the treatment of facial rhytids published to date, including those enrolling Asian subjects, physician assessment has been the primary measure of therapeutic outcome (12)(13)(14)(15). Considering the importance of subject satisfaction to the treating physician to drive repeat treatments and indeed to motivate treatment-naive subjects to seek botulinum toxin through word of mouth, reliable, easy-to-administer, PRO scales are fundamental.…”

“…Results from the current study suggest that onabotulinumtoxinA treatment in combination with laser therapy may be associated with longer duration of effect and similar side effects compared with onabotulinumtoxinA treatment alone. The pivotal study supporting registration of onabotulinumtoxinA for GL in China enrolled a total of 227 Chinese subjects with moderate to severe rhytids at maximum frown for treatment with onabotulinumtoxinA (15). The primary endpoint for the pivotal study was the proportion of subjects achieving a grade of none or mild severity in their GL at maximum frown.…”

“…This led to an extensive clinical development program for one BoNT-A, onabotulinumtoxinA (Botox ® ; Allergan plc, Dublin, Ireland), in the treatment of facial rhytids, including GL (12)(13)(14)(15). This clinical program led to the regulatory approval of onabotulinumtoxinA for the treatment of GL in multiple countries worldwide, including in the US, Canada, Australia, China, Taiwan, Japan, and South Korea (16)(17)(18).…”

“…The pivotal study to support the registration of onabotulinumtoxinA for GL in China demonstrated reproducible efficacy and safety of onabotulinumtoxinA in Chinese subjects (15). The primary endpoint of the pivotal study, the proportion of subjects achieving at least a one-grade improvement in GL severity at maximum frown ("responders"), was assessed by investigators using the validated four-grade Facial Wrinkle Scale (FWS).…”