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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: January 17, 2013
Last verified: January 2013
History of Changes
  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:

MedlinePlus related topics: Botox
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Patient Satisfaction with BOTOX® Treatment of Glabellar Lines [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient's Overall Satisfaction of Effectiveness of BOTOX® Treatment for Glabellar Lines [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Physician's Overall Satisfaction of Effectiveness of BOTOX® Treatment for Glabellar Lines [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Enrollment: 208
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
botulinum toxin type A (BOTOX®)
botulinum toxin type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator
 Biological: botulinum toxin type A
botulinum toxin type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator
Other Names:
  • BOTOX®
  • OnabotulinumtoxinA

  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
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
Last Updated: January 17, 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 May 19, 2013