NCT02195687

Brief Summary

This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared with placebo in patients with moderate to severe crow's feet lines (lateral canthal lines).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
417

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

July 18, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
10 months until next milestone

Results Posted

Study results publicly available

March 14, 2016

Completed
Last Updated

March 14, 2016

Status Verified

February 1, 2016

Enrollment Period

5 months

First QC Date

July 18, 2014

Results QC Date

February 17, 2016

Last Update Submit

February 17, 2016

Conditions

Lateral Canthal LinesCrow's Feet Lines

Outcome Measures

Primary Outcomes (1)

  • Percentage of Subjects Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)

    The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.

    Day 30

Secondary Outcomes (5)

  • Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Rest Using the 4-point FWS-A

    Day 30

  • Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Maximum Smile on the 4-point FWS-A

    Day 30

  • Percentage of Subjects Reporting Their Global Change in Appearance as Very Much Improved or Much Improved Using the 7-point Subject's Global Assessment of Change in CFL (SGA-CFL)

    Day 30

  • Percentage of Subjects Assessing Their Age-related Facial Appearance as Looking Younger on the Self-Perception of Age (SPA) Questionnaire

    Baseline, Day 30

  • Percentage of Subjects Achieving None or Mild on the Subject's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)

    Day 30

Study Arms (2)

botulinum toxin type A

EXPERIMENTAL

24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.

Biological: botulinum toxin Type A

placebo

PLACEBO COMPARATOR

Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.

Drug: Normal Saline

Interventions

botulinum toxin Type ABIOLOGICAL

botulinum toxin Type A (BOTOX®) injected into bilateral crow's feet line areas.

Also known as: BOTOX®
botulinum toxin type A
Normal SalineDRUG

Normal Saline (placebo) injected into bilateral Crow's Feet Line areas.

placebo

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.

You may not qualify if:

  • Current or previous treatment with botulinum toxin of any serotype for any condition within the last year
  • Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
  • Facial laser or light treatment, microdermabrasion or chemical peels within 3 months
  • Radio frequency laser treatments, phototherapy, blepharoplasty, brow-lift or related procedure, permanent make-up, oral retinoid therapy or treatment with non-permanent soft tissue fillers within 1 year
  • Any medium-depth or deep facial peels within 5 years
  • Periorbital surgery, face-lift, mid facial or periorbital treatment with permanent soft tissue fillers, synthetic implants or autologous fat transplant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Beijing, China

Location

Related Publications (1)

  • Wu Y, Li C, Garcia J, Baradaran S. Patient-reported Outcomes in Chinese Subjects Treated with OnabotulinumtoxinA for Crow's Feet Lines. J Clin Aesthet Dermatol. 2021 Oct;14(10):27-31.

    PMID: 34976286DERIVED

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
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2014

First Posted

July 21, 2014

Study Start

September 1, 2014

Primary Completion

February 1, 2015

Study Completion

June 1, 2015

Last Updated

March 14, 2016

Results First Posted

March 14, 2016

Record last verified: 2016-02

Locations

CN(1)