Multicenter, Randomized, Phase III Study of a Single Dose of IncobotulinumtoxinA, Free from Complexing Proteins, in the Treatment of Glabellar Frown Lines

BACKGROUND Botulinum toxin type A is a proven, effective aesthetic treatment for glabellar frown lines. IncobotulinumtoxinA (NT 201, Xeomin/Xeomeen/Bocouture, Merz Pharmaceuticals GmbH, Frankfurt, Germany) is a 150‐kDa botulinum toxin type A free of complexing proteins. OBJECTIVE To assess the efficacy and safety of incobotulinumtoxinA in a randomized, double‐blind, placebo‐controlled, Phase III study in patients with moderate to severe glabellar frown lines. MATERIALS AND METHODS Two hundred seventy‐six patients were randomized 2:1 to receive a single injection of 20 U of incobotulinumtoxinA or placebo, respectively. Efficacy was assessed at day 30 using a Food and Drug Administration–mandated composite endpoint; a responder was defined as a patient with a 2‐point or greater improvement in glabellar frown lines on a 4‐point scale as assessed by investigator and patient. Safety was assessed periodically through Day 120. RESULTS Treatment with a single dose of incobotulinumtoxinA was significantly superior to placebo in the treatment of glabellar frown lines at Day 30 using the composite endpoint (p < .001), with investigators and patients assessing glabellar frown lines as significantly more improved after incobotulinumtoxinA injection than with placebo (p < .001). IncobotulinumtoxinA was well tolerated. CONCLUSION A single dose of 20 U of incobotulinumtoxinA demonstrated efficacy and safety in the treatment of glabellar frown lines using new Food and Drug Administration efficacy variables.