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

Study Overview
=================
Brief Summary
-----------------
This is an observational study assessing patient satisfaction following at least 5 years of BOTOX® treatment for glabellar lines.

Conditions
-----------------
Glabellar Lines

Intervention / Treatment
-----------------
* Biological: botulinum toxin Type A


Participation Criteria
=================
Eligibility 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®

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All participants<br>Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over at least 5 years. | Biological: botulinum toxin Type A<br>* botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over at least 5 years.<br>* Other names: Vistabel®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) |