NCT00430963

IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines

A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Trial With an Open-label Extension Period to Investigate the Efficacy and Safety of IncobotulinumtoxinA (Xeomin), Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Merz Pharmaceuticals GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free of complexing proteins, i.e. free of proteins other than the active toxin. Injected into the muscle, IncobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used for aesthetic treatment of facial lines. This study investigated the efficacy and safety of IncobotulinumtoxinA (Xeomin) in the treatment of glabellar frown lines compared to placebo. The study consisted of a Main Period and an Open-Label Extension \[OLEX\] Period of 120 days each.

Conditions

• Glabellar Frown Lines

Interventions

Type	Name	Description
DRUG	IncobotulinumtoxinA (Xeomin) (20 Units)
DRUG	Placebo

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-04-01
• Completion: 2007-11-01
• First posted: 2007-02-02
• Last updated: 2011-10-26

Locations

1 site across 1 country: Germany