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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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®
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Scientific title
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Secondary ID [1]
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GMA-BTXC-11-004
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Glabellar Lines
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Other - 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.
Treatment: Other: botulinum toxin Type A
botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over at least 5 years.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Mostly or Very Satisfied With Their Glabellar Lines on the Facial Line Satisfaction Questionnaire (FLSQ)
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Assessment method [1]
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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.
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Timepoint [1]
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Study Day 1 (approximately 4-28 weeks following last treatment)
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Secondary outcome [1]
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Percentage of Participants Mostly or Very Satisfied With Effectiveness of = 5 Years BOTOX® Treatments Using the Patient Questionnaire
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Assessment method [1]
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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.
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Timepoint [1]
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Study Day 1 (approximately 4-28 weeks following last treatment)
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Secondary outcome [2]
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Percentage of Participants Where Physician Was Mostly or Very Satisfied With Effectiveness of = 5 Years BOTOX® Treatments Using the Physician Questionnaire
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Assessment method [2]
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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.
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Timepoint [2]
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Study Day 1 (approximately 4-28 weeks following last treatment)
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Eligibility
Key inclusion criteria
* At least one BOTOX® treatment for facial wrinkles (glabellar lines) per calendar year for =5 years
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Received botulinum toxin formulations other than BOTOX®
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/12/2012
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Sample size
Target
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Accrual to date
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Final
207
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- South Yarra
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Recruitment postcode(s) [1]
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- South Yarra
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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Brazil
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State/province [2]
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Sao Paolo
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Country [3]
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Canada
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State/province [3]
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Ontario
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Country [4]
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France
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State/province [4]
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Cannes
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Allergan
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is an observational study assessing patient satisfaction following at least 5 years of BOTOX® treatment for glabellar lines.
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Trial website
https://clinicaltrials.gov/study/NCT01608672
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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.
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Allergan
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01608672
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