NCT00541723

Efficacy and Safety of NT 201 in the Treatment of Lateral Periorbital Wrinkles

A Prospective, Randomized, Double-Blind, Multicenter Trial to Investigate the Efficacy and Safety of NT 201 in Comparison to Placebo and to Compare Two Different Application Schemes of NT 201 in the Treatment of Lateral Periorbital Wrinkles

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Merz Pharmaceuticals GmbH · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

To investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in comparison to placebo in the treatment of moderate to severe lateral periorbital wrinkles at maximum smile and to compare two different application schemes of Xeomin. Each subject will be treated on the right and left eye area, using the same dose but different application schemes (i.e. 3 or 4 injection sites).

Detailed description

Conducted in Europe

Conditions

• Lateral Periorbital Wrinkles

Interventions

Type	Name	Description
DRUG	IncobotulinumtoxinA (Xeomin)	Intramuscular injection at day 0, at 3 and 4 injection sites per eye (4 x 3 or 3 x 4 units = 12 units per eye)
DRUG	Placebo	Intramuscular injection at day 0, at 3 and 4 injection sites per eye.

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-02-01
• Completion: 2008-05-01
• First posted: 2007-10-10
• Last updated: 2012-03-08

Locations

12 sites across 4 countries: France, Germany, Italy, United Kingdom