NCT01224015

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
684

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2011

Shorter than P25 for phase_3

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

February 25, 2014

Completed
Last Updated

February 25, 2014

Status Verified

February 1, 2014

Enrollment Period

5 months

First QC Date

October 18, 2010

Results QC Date

September 27, 2013

Last Update Submit

February 24, 2014

Conditions

Facial RhytidesCrow's Feet LinesGlabellar Lines

Outcome Measures

Primary Outcomes (1)

  • 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

    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.

    Day 30

Study Arms (3)

onabotulinumtoxinA 24U

OTHER

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.

Drug: normal salineBiological: onabotulinumtoxinA 24 U

placebo (normal saline)

PLACEBO COMPARATOR

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.

Drug: normal saline

onabotulinumtoxinA 44U

EXPERIMENTAL

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.

Biological: onabotulinumtoxinA 44 U

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 24Uplacebo (normal saline)
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.

Also known as: BOTOX®, BOTOX® Cosmetic, onabotulinumtoxinA
onabotulinumtoxinA 44U
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.

Also known as: BOTOX®, BOTOX® Cosmetic, onabotulinumtoxinA
onabotulinumtoxinA 24U

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Successfully completed Study 191622-099

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Newport Beach, California, United States

Location

Unknown Facility

Vancouver, British Columbia, Canada

Location

Unknown Facility

Antibes, France

Location

Unknown Facility

Berlin, Germany

Location

MeSH Terms

Interventions

Saline SolutionBotulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsBotulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Results Point of Contact

Title
Therapeutic Area Head,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2010

First Posted

October 19, 2010

Study Start

May 1, 2011

Primary Completion

October 1, 2011

Study Completion

February 1, 2012

Last Updated

February 25, 2014

Results First Posted

February 25, 2014

Record last verified: 2014-02

Locations

FR(1)CA(1)US(1)DE(1)