CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 917 enrolled
Drug / intervention
onabotulinumtoxinA 24 U +2 morebiological
Likely dose
onabotulinumtoxinA 24 U 24 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01189760
NCT01189760Phase 3Completed
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Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines

Allergan·interventional·Posted Aug 27, 2010·Updated Apr 16, 2019

In Brief

A Phase 3 clinical trial evaluating onabotulinumtoxinA 24 U, onabotulinumtoxinA 44 U, and 1 other intervention for Facial Rhytides and 2 related conditions. Completed, enrolled 917 participants across 4 sites in 4 countries.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFacial Rhytides, Crow's Feet Lines, Glabellar Lines
CountriesCanada, France, Germany, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 27, 2010
Enrollment StartSep 1, 2010
Primary CompletionMar 1, 2011
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 15.8 years ago

Interventions

onabotulinumtoxinA 24 Ubiological

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.

onabotulinumtoxinA 44 Ubiological

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

normal salinedrug

Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart.