Frown Lines Clinical Trial
Official title:
A Double-Blinded, Randomized, Controlled Study to Compare the Efficacy, Time to Onset, and Duration of Effect of Botulinum Type A Toxins in the Treatment of Glabellar Frown Lines
The purpose of the study is to provide preliminary comparative data on BoNT/A-DP versus Botox Cosmetic. Subsequently the sample size is primarily based on clinical judgement and practical considerations.
This will be a multi-center, randomized, double-blind, comparator-controlled study. The study will take place in the EU, US and Canada. To allow all subjects to profit from treatment and to obtain adequate data for BoNT/A DP treatment, the study will be comprised of a double-blinded treatment comparing BoNT/A-DP with Botox Cosmetic (ratio 1:1). Primary and secondary endpoints will compare efficacy, safety and subject satisfaction after a single treatment of the investigational BoNT/A DP to an existing commercially available product (Botox Cosmetic). Two hundred subjects will be enrolled, which should allow for a precise estimate of response rate and for post-hoc sensitivity analyses. The duration of study participation for each subject will be up to 18 weeks, to include screening (maximum of 2 weeks; re-screening will not be permitted), and a single treatment (comprised of one injection at five injection points) of BoNT/A-DP (Group A) or Botox Cosmetic (Group B) followed by six efficacy and safety follow-up visits. A total of 200 subjects will be randomized 1:1 to Group A or Group B at Baseline. Both investigators and subjects will be blinded to treatment. Investigators and subjects will evaluate the severity of glabellar lines independently. ;
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