Glabellar Lines
Conditions
Brief summary
This is an observational study assessing patient satisfaction following at least 5 years of BOTOX® treatment for glabellar lines.
Interventions
BIOLOGICALbotulinum toxin Type A
botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over at least 5 years.
Sponsors
Allergan
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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®
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Mostly or Very Satisfied With Their Glabellar Lines on the Facial Line Satisfaction Questionnaire (FLSQ) | Study Day 1 (approximately 4-28 weeks following last treatment) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 | Study Day 1 (approximately 4-28 weeks following last treatment) | 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. |
Countries
Australia, Brazil, Canada, France, United States
Participant flow
Pre-assignment details
Eligible patients were identified by retrospective chart review. Demographic and Outcome Measure data were collected at a study visit on Day 1 (approximately 4-28 weeks following last treatment) for patients who received treatment with BOTOX® for ≥5 years. Adverse Event data was collected by retrospective chart review.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years. | 207 |
| Total | 207 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 55.6 years STANDARD_DEVIATION 10.2 |
| Sex: Female, Male Female | 194 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 23 / 207 |
| serious Total, serious adverse events | 0 / 207 |
Outcome results
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.
Time frame: Study Day 1 (approximately 4-28 weeks following last treatment)
Population: Per Protocol population included all enrolled participants who met eligibility criteria with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants Mostly or Very Satisfied With Their Glabellar Lines on the Facial Line Satisfaction Questionnaire (FLSQ) | 92.3 Percentage of participants |
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.
Time frame: Study Day 1 (approximately 4-28 weeks following last treatment)
Population: Per Protocol population included all enrolled participants who met eligibility criteria with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants Mostly or Very Satisfied With Effectiveness of ≥ 5 Years BOTOX® Treatments Using the Patient Questionnaire | 95.8 Percentage of participants |
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.
Time frame: Study Day 1 (approximately 4-28 weeks following last treatment)
Population: Per Protocol population included all enrolled participants who met eligibility criteria with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Percentage of Participants Where Physician Was Mostly or Very Satisfied With Effectiveness of ≥ 5 Years BOTOX® Treatments Using the Physician Questionnaire | 98.0 Percentage of participants |