Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01608672




Registration number
NCT01608672
Ethics application status
Date submitted
29/05/2012
Date registered
31/05/2012
Date last updated
16/04/2019

Titles & IDs
Public title
Long-Term Patient Satisfaction of Facial Aesthetic Treatment With BOTOX®
Scientific title
Secondary ID [1] 0 0
GMA-BTXC-11-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glabellar Lines 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - botulinum toxin Type A

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


Other interventions: botulinum toxin Type A
botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over at least 5 years.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Mostly or Very Satisfied With Their Glabellar Lines on the Facial Line Satisfaction Questionnaire (FLSQ)
Timepoint [1] 0 0
Study Day 1 (approximately 4-28 weeks following last treatment)
Secondary outcome [1] 0 0
Percentage of Participants Mostly or Very Satisfied With Effectiveness of = 5 Years BOTOX® Treatments Using the Patient Questionnaire
Timepoint [1] 0 0
Study Day 1 (approximately 4-28 weeks following last treatment)
Secondary outcome [2] 0 0
Percentage of Participants Where Physician Was Mostly or Very Satisfied With Effectiveness of = 5 Years BOTOX® Treatments Using the Physician Questionnaire
Timepoint [2] 0 0
Study Day 1 (approximately 4-28 weeks following last treatment)

Eligibility
Key inclusion criteria
- At least one BOTOX® treatment for facial wrinkles (glabellar lines) per calendar year
for =5 years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Received botulinum toxin formulations other than BOTOX®

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2012
Sample size
Target
Accrual to date
Final
207
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- South Yarra
Recruitment postcode(s) [1] 0 0
- South Yarra
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
Brazil
State/province [2] 0 0
Sao Paolo
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
France
State/province [4] 0 0
Cannes

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is an observational study assessing patient satisfaction following at least 5 years of
BOTOX® treatment for glabellar lines.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01608672
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01608672