A randomized, placebo-controlled, double-blind phase iii trial investigating the efficacy and safety of incobotulinumtoxin A in the treatment of glabellar frown lines using a stringent composite endpoint

Abstract

Background A prospective, randomized, double-blind, multicenter, Phase III trial of incobotulinumtoxinA using new Food and Drug Administration endpoints. Objective To investigate the efficacy and safety of a single dose of incobotulinumtoxinA for the treatment of glabellar frown lines. Materials and Methods Two hundred seventy-one subjects with moderate to severe glabellar frown lines at maximum frown - as assessed by an investigator according to the facial wrinkle scale (FWS) - were randomized 2:1 to receive one treatment of 20 U of incobotulinumtoxinA or placebo, respectively, and assessed over 120 days. The primary efficacy variable was a composite endpoint consisting of patients who were 2-point or more responders at maximum frown on Day 30 according to the investigator's rating on the FWS, and 2-point or more responders at maximum frown on Day 30 according to the patient's assessment on a 4-point scale. Safety analyses were performed throughout the study. Results IncobotulinumtoxinA was statistically significantly more efficacious than placebo using a new rigorous composite endpoint (p