CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 300 enrolled
Drug / intervention
botulinum toxin Type A (24 U) +2 morebiological
Likely dose
botulinum toxin Type A (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/NCT01797081
NCT01797081Phase 3Completed
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BOTOX® in the Treatment of Crow's Feet Lines in Japan

Allergan·interventional·Posted Feb 22, 2013·Updated Apr 16, 2019

In Brief

A Phase 3 clinical trial evaluating botulinum toxin Type A (24 U), botulinum toxin Type A (12 U), and 1 other intervention for Lateral Canthus Rhytides and Crow's Feet Lines. Completed, enrolled 300 participants across 1 site.

Detailed Summary

This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared to placebo for the treatment of Crow's Feet Lines (Lateral Canthus Rhytides).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLateral Canthus Rhytides, Crow's Feet Lines
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 22, 2013
Enrollment StartJan 31, 2013
Primary CompletionJul 18, 2013
Study CompletionJul 7, 2014
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 13.4 years ago

Interventions

botulinum toxin Type A (24 U)biological

24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment.

botulinum toxin Type A (12 U)biological

12 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment.

Normal Salineother

Normal saline (placebo) injected into bilateral Crow's Feet Line areas per treatment.