NCT01189760

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)

Trial Health

90
On Track

Trial Health Score

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

Enrollment
917

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2010

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

August 25, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2010

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

December 3, 2013

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

6 months

First QC Date

August 25, 2010

Results QC Date

September 27, 2013

Last Update Submit

April 3, 2019

Conditions

Facial RhytidesCrow's Feet LinesGlabellar Lines

Outcome Measures

Primary Outcomes (1)

  • Percentage of Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile

    The composite facial wrinkle scale assessment is based on both the Investigator and Subject Facial Wrinkle scales at 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 and the patient assessed the severity of their Crow's Feet Lines at maximum smile using the same 4-point Facial Wrinkle Scale. A responder is defined as a participant with a ≥ 2-grade improvement from Baseline.

    Baseline, Day 30

Secondary Outcomes (8)

  • 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

  • Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Maximum Smile

    Baseline, Day 30

  • Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines at Rest

    Baseline, Day 30

  • Subject Global Assessment of Change in Crow's Feet Lines (SGA-CFL) Score

    Day 30

  • Percentage of Participants Who Judged Themselves in a Younger Self-Perception of Age Category Than at Baseline

    Baseline, Day 30

  • +3 more secondary outcomes

Study Arms (3)

onabotulinumtoxinA 44U

EXPERIMENTAL

44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.

Biological: onabotulinumtoxinA 44 U

onabotulinumtoxinA 24U

OTHER

24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.

Biological: onabotulinumtoxinA 24 UDrug: normal saline

placebo (normal saline)

PLACEBO COMPARATOR

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

Drug: normal saline

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.

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

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

onabotulinumtoxinA 24Uplacebo (normal saline)

Eligibility Criteria

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

You may qualify if:

  • Moderate to severe Crow's Feet Lines and Frown Lines
  • Have adequate vision without the use of eyeglasses to assess facial wrinkles in the mirror (contact lenses OK)

You may not qualify if:

  • Current or previous botulinum toxin treatment of any serotype
  • Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
  • Prior facial cosmetic surgery (e.g., prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery)
  • Facial laser or light treatment, microdermabrasion, or superficial peels within 3 months
  • Oral retinoid therapy within one year

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

Related Publications (1)

  • Moers-Carpi M, Carruthers J, Fagien S, Lupo M, Delmar H, Jones D, Somogyi C, Lee E, Lei X, MacKinnon S, Davis PG, Yalamanchili R, Campo A, Beddingfield FC 3rd. Efficacy and safety of onabotulinumtoxinA for treating crow's feet lines alone or in combination with glabellar lines: a multicenter, randomized, controlled trial. Dermatol Surg. 2015 Jan;41(1):102-12. doi: 10.1097/DSS.0000000000000220.

    PMID: 25485803BACKGROUND

MeSH Terms

Interventions

Botulinum Toxins, Type ASaline Solution

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological FactorsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

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

August 25, 2010

First Posted

August 27, 2010

Study Start

September 1, 2010

Primary Completion

March 1, 2011

Study Completion

September 1, 2011

Last Updated

April 16, 2019

Results First Posted

December 3, 2013

Record last verified: 2019-04

Locations

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