Long-Term Patient Satisfaction of Facial Aesthetic Treatment With BOTOX®

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01608672
First received: May 29, 2012
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

This is an observational study assessing patient satisfaction following at least 5 years of BOTOX® treatment for glabellar lines.


Condition Intervention
Glabellar Lines
Biological: botulinum toxin Type A

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Participants Mostly or Very Satisfied With Their Glabellar Lines on the Facial Line Satisfaction Questionnaire (FLSQ) [ Time Frame: Study Day 1 (approximately 4-28 weeks following last treatment) ] [ Designated as safety issue: No ]
    Participants assessed their overall satisfaction with their glabellar lines by answering FLSQ Question 5: "How satisfied are you with the effect your treatment had on your facial lines?" using a 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.


Secondary Outcome Measures:
  • Percentage of Participants Mostly or Very Satisfied With Effectiveness of ≥ 5 Years BOTOX® Treatments Using the Patient Questionnaire [ Time Frame: Study Day 1 (approximately 4-28 weeks following last treatment) ] [ Designated as safety issue: No ]
    Participants rated their overall satisfaction with BOTOX® treatment by answering the question on the Patient Reported Overall Satisfaction of Effectiveness Questionnaire: "You have received BOTOX® facial aesthetic treatment(s) for at least 5 years. How satisfied overall are you with the effect of BOTOX®?" using the following possible answers: Very Dissatisfied, Mostly Dissatisfied, Neither Satisfied or Dissatisfied, Mostly Satisfied or Very Satisfied. The percentage of participants who answered Mostly Satisfied or Very Satisfied is reported.

  • Percentage of Participants Where Physician Was Mostly or Very Satisfied With Effectiveness of ≥ 5 Years BOTOX® Treatments Using the Physician Questionnaire [ Time Frame: Study Day 1 (approximately 4-28 weeks following last treatment) ] [ Designated as safety issue: No ]
    Physicians rated their overall satisfaction with BOTOX® treatment by answering the question on the Physician Reported Overall Satisfaction of Effectiveness Questionnaire: "You have treated this patient with BOTOX® facial aesthetic treatment(s) for at least 5 years. How satisfied overall are you with the effect of BOTOX®?" using the following possible answers: Very Dissatisfied, Mostly Dissatisfied, Neither Satisfied or Dissatisfied, Mostly Satisfied or Very Satisfied. The percentage of participants where the physician answered Mostly Satisfied or Very Satisfied is reported.


Enrollment: 207
Study Start Date: April 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All participants
Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over at least 5 years.
Biological: botulinum toxin Type A
botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over at least 5 years.
Other Names:
  • BOTOX®
  • OnabotulinumtoxinA
  • BOTOX® Cosmetic
  • Vistabel®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects treated for at least 5 years with BOTOX® for glabellar lines

Criteria

Inclusion Criteria:

  • At least one BOTOX® treatment for facial wrinkles (glabellar lines) per calendar year for ≥5 years

Exclusion Criteria:

  • Received botulinum toxin formulations other than BOTOX®
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608672

Locations
United States, Florida
Coral Gables, Florida, United States
Australia
South Yarra, Australia
Brazil
Sao Paolo, Brazil
Canada, Ontario
Niagara Falls, Ontario, Canada
France
Cannes, France
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01608672     History of Changes
Other Study ID Numbers: GMA-BTXC-11-004
Study First Received: May 29, 2012
Results First Received: November 4, 2013
Last Updated: November 4, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
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 April 21, 2014