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

NCT01608672 | Completed Results

• 1 other identifier: GMA-BTXC-11-004
• Study Type: observational
• Target: 207
• Locations: 5 countries
• Sites: 5

Brief Summary

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

Conditions

Glabellar Lines

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Mostly or Very Satisfied With Their Glabellar Lines on the Facial Line Satisfaction Questionnaire (FLSQ)

  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.

  Study Day 1 (approximately 4-28 weeks following last treatment)

Secondary Outcomes (2)

• Percentage of Participants Mostly or Very Satisfied With Effectiveness of ≥ 5 Years BOTOX® Treatments Using the Patient Questionnaire

  Study Day 1 (approximately 4-28 weeks following last treatment)

• Percentage of Participants Where Physician Was Mostly or Very Satisfied With Effectiveness of ≥ 5 Years BOTOX® Treatments Using the Physician Questionnaire

  Study Day 1 (approximately 4-28 weeks following last treatment)

Study Arms (1)

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

Interventions

botulinum toxin Type A BIOLOGICAL

botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over at least 5 years.

Also known as: BOTOX®, OnabotulinumtoxinA, BOTOX® Cosmetic, Vistabel®

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Received botulinum toxin formulations other than BOTOX®

Sponsors & Collaborators

• Allergan: lead

Study Sites (5)

Unknown Facility

Coral Gables, Florida, United States

Location

Unknown Facility

South Yarra, Australia

Location

Unknown Facility

São Paulo, Brazil

Location

Unknown Facility

Niagara Falls, Ontario, Canada

Location

Unknown Facility

Cannes, France

Location

Related Publications (1)

• Trindade de Almeida A, Carruthers J, Cox SE, Goldman MP, Wheeler S, Gallagher CJ. Patient satisfaction and safety with aesthetic onabotulinumtoxinA after at least 5 years: a retrospective cross-sectional analysis of 4,402 glabellar treatments. Dermatol Surg. 2015 Jan;41 Suppl 1:S19-28. doi: 10.1097/DSS.0000000000000275.

  PMID: 25548841 BACKGROUND

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

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
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: May 31, 2012
• Study Start: April 1, 2012
• Primary Completion: December 31, 2012
• Study Completion: December 31, 2012
• Last Updated: April 16, 2019
• Results First Posted: December 23, 2013

Record last verified: 2019-04

Locations

BR (1); FR (1); CA (1); US (1); AU (1)