NCT02261467

A Safety and Efficacy Study of OnabotulinumtoxinA in Forehead and Glabellar Facial Rhytides

Evaluation of the Safety and Efficacy of Treatment With BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for Subjects With Forehead and Glabellar Facial Rhytides

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 421 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a safety and efficacy study of onabotulinumtoxinA in subjects with forehead and glabellar facial rhytides (frown lines).

Conditions

• Forehead Rhytides
• Glabellar Rhytides

Interventions

Type	Name	Description
BIOLOGICAL	OnabotulinumtoxinA	OnabotulinumtoxinA injected into the protocol-specified areas. Subjects will receive at least 1 and up to 3 treatments.
DRUG	Normal Saline	Placebo (normal saline) injected into the protocol-specified areas on Day 1.

Timeline

• Start date: 2014-10-21
• Primary completion: 2015-06-04
• Completion: 2016-04-26
• First posted: 2014-10-10
• Last updated: 2019-01-08
• Results posted: 2017-06-23

Locations

16 sites across 3 countries: United States, Canada, Ireland

Regulatory

• FDA-regulated drug study