Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines

Phase 3

Completed

• Conditions: Facial Rhytides; Glabellar Lines; Crow's Feet Lines
• Interventions: Drug: normal saline; Biological: onabotulinumtoxinA 44 U; Biological: onabotulinumtoxinA 24 U

• Registration Number: NCT01224015
• Lead Sponsor: Allergan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2010-10-18
• Study First Posted: 2010-10-19
• Study Start: 2011-05
• Primary Completion: 2011-10
• Study Completion: 2012-02
• Disposition First Submitted: 2012-10-22
• Disposition First Submitted QC: 2012-10-22
• Disposition First Posted: 2012-10-26
• Results First Submitted: 2013-09-27
• Status Verified: 2014-02
• Results First Submitted QC: 2014-02-24
• Last Update Submitted: 2014-02-24
• Results First Posted: 2014-02-25
• Last Update Posted: 2014-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 684

Inclusion Criteria

• Successfully completed Study 191622-099

Exclusion Criteria

• Known immunization or hypersensitivity to botulinum toxin of any serotype
• Anticipated need for treatment with botulinum toxin of any serotype during the study (except for study treatment)
• Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
• Anticipated need for surgery or hospitalization during the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
onabotulinumtoxinA 24U	normal saline	24 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.
onabotulinumtoxinA 24U	onabotulinumtoxinA 24 U	24 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.
placebo (normal saline)	normal saline	Normal Saline (placebo) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.
onabotulinumtoxinA 44U	onabotulinumtoxinA 44 U	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines	Day 30	The investigator assessed the severity of the patient's Crow's Feet Lines at maximum smile using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.