NCT01391299

Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Forehead and Frown Lines

A Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Single Treatment Cycle Study of BOTOX® Cosmetic (Botulinum Toxin Type A) Purified Neurotoxin Complex in Subjects With Forehead and Glabellar Rhytides

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of forehead lines (facial rhytides) when also administered to frown lines (glabellar rhytides).

Conditions

• Facial Rhytides
• Glabellar Frown Lines

Interventions

Type	Name	Description
BIOLOGICAL	botulinum toxin Type A	Botulinum toxin Type A (total dose 30 Units or 40 Units) injected into bilateral forehead and frown line areas on Day 1.
DRUG	Normal Saline	Normal Saline (placebo) injected into bilateral forehead and frown line areas on Day 1.

Timeline

• Start date: 2011-06-01
• Primary completion: 2011-10-18
• Completion: 2012-02-28
• First posted: 2011-07-12
• Last updated: 2019-04-17
• Results posted: 2012-11-26

Locations

1 site across 1 country: Canada