A Study of Subject Satisfaction With BOTOX® Cosmetic Treatment in Facial Rhytides

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01777620
First received: January 25, 2013
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Facial Rhytides
Biological: onabotulinumtoxinA
Drug: Normal Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Participants Satisfied With Treatment of Glabellar Lines Assessed Using the Facial Line Satisfaction Questionnaire (FLSQ) [ Time Frame: Day 60 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants Satisfied With Treatment of Crow's Feet Lines (CFL) and Glabellar Lines Assessed Using the FLSQ [ Time Frame: Day 60 ] [ Designated as safety issue: No ]
    Participants assessed their overall satisfaction with both their CFL and glabellar 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 mostly or very satisfied is reported.

  • Percentage of Participants Satisfied With Duration of Treatment of Glabellar Lines Assessed Using the FLSQ [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    Participants assessed their overall satisfaction with duration of treatment of glabellar 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.

  • Percentage of Participants Where Treatment of Glabellar Lines Met Expectation Assessed Using the FLSQ [ Time Frame: Day 60 ] [ Designated as safety issue: No ]
    Participants assessed whether treatment of their glabellar lines met expectation using the FLSQ 3-point scale where: 1=Worse than expected, 2=Met expectations and 3=Better than expected. The percentage of participants with responses Met expectations and Better than expected is reported.

  • Percentage of Participants Satisfied With Duration of Treatment of CFL and Glabellar Lines Assessed Using the FLSQ [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    Participants assessed their overall satisfaction with duration of treatment of both CFL and glabellar 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.

  • Percentage of Participants Where Treatment of CFL and Glabellar Lines Met Expectation Assessed Using the FLSQ [ Time Frame: Day 60 ] [ Designated as safety issue: No ]
    Participants assessed whether treatment of glabellar lines met expectations using the FLSQ 3-point scale where: 1=Worse than expected, 2=Met expectations and 3=Better than expected. The percentage of participants with responses Met expectations and Better than expected is reported.

  • Percentage of Participants Who Were Likely to Continue Treatment of Glabellar Lines Assessed Using the FLSQ [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    Participants assessed how likely they were to continue treatment of glabellar Lines using the FLSQ 5-point scale where: 1=Not at all, 2=A little bit, 3=Moderately, 4=Quite a bit and 5=Extremely. The percentage of participants with responses Moderately, Quite a bit and Extremely is reported.

  • Percentage of Participants Who Were Likely to Continue Treatment of CFL and Glabellar Lines Assessed Using the FLSQ [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    Participants assessed how likely they were to continue treatment of CFL and glabellar Lines using the FLSQ 5-point scale where: 1=Not at all, 2=A little bit, 3=Moderately, 4=Quite a bit and 5=Extremely. The percentage of participants with responses Moderately, Quite a bit and Extremely is reported.

  • Percentage of Participants With a Score of None or Mild in the Investigator's Assessment of the Severity of Glabellar Lines at Maximum Frown Assessed Using the FWS [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    The Investigator assessed the severity of the patient's glabellar lines at maximum frown using the 4-point Facial Wrinkle Scale (FWS) where: 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of participants with a score of none or mild is reported.

  • Percentage of Participants With at Least a 1-Grade Improvement in the Investigator's Assessment of the Severity of CFL at Maximum Smile Assessed Using the FWS [ Time Frame: Baseline, Day 30 ] [ Designated as safety issue: No ]
    The Investigator assessed the severity of the patient's CFL at maximum smile using the 4-point FWS where: 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of participants with at least a 1-Grade improvement from Baseline is reported.


Enrollment: 125
Study Start Date: January 2013
Study Completion Date: July 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BOTOX®
BOTOX® (onabotulinumtoxinA) injected into the areas of glabellar lines and crow's feet lines on Day 1.
Biological: onabotulinumtoxinA
BOTOX® (onabotulinumtoxinA) injected into the areas of glabellar lines and crow's feet lines on Day 1.
Other Names:
  • botulinum toxin Type A
  • BOTOX®
  • BOTOX® Cosmetic
Placebo Comparator: Placebo
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
Drug: Normal Saline
Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777620

Locations
Canada, Ontario
Toronto, Ontario, Canada
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01777620     History of Changes
Other Study ID Numbers: GMA-BTXC-12-001
Study First Received: January 25, 2013
Results First Received: May 2, 2014
Last Updated: May 2, 2014
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Facies
Disease Attributes
Pathologic Processes
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014