Trial Outcomes & Findings for Long-Term Patient Satisfaction of Facial Aesthetic Treatment With BOTOX® (NCT NCT01608672)
NCT ID: NCT01608672
Last Updated: 2019-04-16
Results Overview
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.
COMPLETED
207 participants
Study Day 1 (approximately 4-28 weeks following last treatment)
2019-04-16
Participant Flow
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.
Participant milestones
| Measure |
All Participants
Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
|
|---|---|
|
Overall Study
STARTED
|
207
|
|
Overall Study
COMPLETED
|
207
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long-Term Patient Satisfaction of Facial Aesthetic Treatment With BOTOX®
Baseline characteristics by cohort
| Measure |
All Participants
n=207 Participants
Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
|
|---|---|
|
Age, Continuous
|
55.6 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
194 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
All Participants
n=194 Participants
Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
|
|---|---|
|
Percentage of Participants Mostly or Very Satisfied With Their Glabellar Lines on the Facial Line Satisfaction Questionnaire (FLSQ)
|
92.3 Percentage of participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
All Participants
n=194 Participants
Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
|
|---|---|
|
Percentage of Participants Mostly or Very Satisfied With Effectiveness of ≥ 5 Years BOTOX® Treatments Using the Patient Questionnaire
|
95.8 Percentage of participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
All Participants
n=194 Participants
Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
|
|---|---|
|
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
|
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
All Participants
n=207 participants at risk
Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
|
|---|---|
|
Nervous system disorders
Facial paresis
|
11.1%
23/207 • The collection period was up to 17 years.
Adverse Event data was collected by retrospective chart review. Only treatment related adverse events were reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER