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

Glabellar Lines Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01608672
• Other study ID #: GMA-BTXC-11-004
• Status: Completed
• Start date: April 1, 2012
• Est. completion date: December 31, 2012

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: December 31, 2012
• Est. primary completion date: December 31, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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®

Related Conditions & MeSH terms

• Glabellar Lines

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  France, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants Mostly or Very Satisfied With Effectiveness of = 5 Years BOTOX® Treatments Using the Patient Questionnaire	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.	Study Day 1 (approximately 4-28 weeks following last treatment)
Secondary	Percentage of Participants Where Physician Was Mostly or Very Satisfied With Effectiveness of = 5 Years BOTOX® Treatments Using the Physician Questionnaire	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.	Study Day 1 (approximately 4-28 weeks following last treatment)