NCT01777620

Brief Summary

This is a safety and efficacy study of BOTOX® in subjects with facial rhytides (glabellar lines and crow's feet lines).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_4

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

January 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

January 31, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2013

Completed
10 months until next milestone

Results Posted

Study results publicly available

May 30, 2014

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

4 months

First QC Date

January 25, 2013

Results QC Date

May 2, 2014

Last Update Submit

April 15, 2019

Conditions

Facial Rhytides

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Satisfied With Treatment of Glabellar Lines Assessed Using the Facial Line Satisfaction Questionnaire (FLSQ)

    Participants assessed their overall satisfaction with their glabellar (frown) lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants with responses mostly or very satisfied is reported.

    Day 60

Secondary Outcomes (9)

  • Percentage of Participants Satisfied With Treatment of Crow's Feet Lines (CFL) and Glabellar Lines Assessed Using the FLSQ

    Day 60

  • Percentage of Participants Satisfied With Duration of Treatment of Glabellar Lines Assessed Using the FLSQ

    Day 90

  • Percentage of Participants Where Treatment of Glabellar Lines Met Expectation Assessed Using the FLSQ

    Day 60

  • Percentage of Participants Satisfied With Duration of Treatment of CFL and Glabellar Lines Assessed Using the FLSQ

    Day 90

  • Percentage of Participants Where Treatment of CFL and Glabellar Lines Met Expectation Assessed Using the FLSQ

    Day 60

  • +4 more secondary outcomes

Study Arms (2)

BOTOX®

ACTIVE COMPARATOR

BOTOX® (onabotulinumtoxinA) injected into the areas of glabellar lines and crow's feet lines on Day 1.

Biological: onabotulinumtoxinA

Placebo

PLACEBO COMPARATOR

Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.

Drug: Normal Saline

Interventions

onabotulinumtoxinABIOLOGICAL

BOTOX® (onabotulinumtoxinA) injected into the areas of glabellar lines and crow's feet lines on Day 1.

Also known as: botulinum toxin Type A, BOTOX®, BOTOX® Cosmetic
BOTOX®
Normal SalineDRUG

Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.

Placebo

Eligibility Criteria

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

You may qualify if:

  • Glabellar lines and crow's feet lines
  • No prior use of botulinum toxin therapy of any serotype for any reason

You may not qualify if:

  • Previous facial cosmetic surgery, tissue grafting, or tissue augmentation with silicone or fat or other permanent fillers
  • Planning a facial cosmetic procedure during the study period
  • Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, and/or amyotrophic lateral sclerosis
  • Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study treatment)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Toronto, Ontario, Canada

Location

Related Publications (1)

  • Rivers JK, Bertucci V, McGillivray W, Muhn C, Rosen N, Solish N, Weichman BM, Wheeler S, Daniels SR, Gallagher CJ. Subject satisfaction with onabotulinumtoxinA treatment of glabellar and lateral canthal lines using a new patient-reported outcome measure. Dermatol Surg. 2015 Aug;41(8):950-9. doi: 10.1097/DSS.0000000000000424.

    PMID: 26218728BACKGROUND

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
Vice President Medical Affairs,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
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

January 25, 2013

First Posted

January 29, 2013

Study Start

January 31, 2013

Primary Completion

May 29, 2013

Study Completion

July 31, 2013

Last Updated

April 17, 2019

Results First Posted

May 30, 2014

Record last verified: 2019-04

Locations

CA(1)