NCT01189760

Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 917 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides)

Conditions

• Facial Rhytides
• Crow's Feet Lines
• Glabellar Lines

Interventions

Type	Name	Description
BIOLOGICAL	onabotulinumtoxinA 24 U	24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart.
BIOLOGICAL	onabotulinumtoxinA 44 U	44 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart
DRUG	normal saline	Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart.

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-03-01
• Completion: 2011-09-01
• First posted: 2010-08-27
• Last updated: 2019-04-16
• Results posted: 2013-12-03

Locations

4 sites across 4 countries: United States, Canada, France, Germany