CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 684 enrolled
Drug / intervention
normal saline +2 moredrug
Likely dose
onabotulinumtoxinA 44 U 44 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/NCT01224015
NCT01224015Phase 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 Oct 19, 2010·Updated Feb 25, 2014

In Brief

A Phase 3 clinical trial evaluating normal saline, onabotulinumtoxinA 44 U, and 1 other intervention for Facial Rhytides and 2 related conditions. Completed, enrolled 684 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) for patients who successfully completed Study 191622-099.

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 PostedOct 19, 2010
Enrollment StartMay 1, 2011
Primary CompletionOct 1, 2011
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 15.7 years ago

Interventions

normal salinedrug

Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.

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 may receive up to 2 treatments during the study.

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 may receive up to 2 treatments during the study.