An Observational Retrospective Study to Evaluate Treatment Patterns of Botulinum Toxin Type A
1 other identifier
observational
110
1 country
1
Brief Summary
This is a retrospective chart review to evaluate treatment patterns of botulinum toxin Type A for the treatment of facial lines.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 17, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 17, 2011
CompletedFirst Submitted
Initial submission to the registry
May 29, 2012
CompletedFirst Posted
Study publicly available on registry
May 31, 2012
CompletedResults Posted
Study results publicly available
August 1, 2012
CompletedApril 17, 2019
April 1, 2019
3 months
May 29, 2012
June 25, 2012
April 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Average Total Dose Per Treatment Period
Average total dose per treatment period was defined as total treatment dose plus total touch-up dose plus total follow-up dose.
24 Months
Secondary Outcomes (2)
Inter-Injection Interval Duration of Each Treatment Period
24 Months
Percent of Subjects Reporting Satisfaction With Treatment Effects
24 Months
Study Arms (1)
botulinum toxin Type A
Previous treatment with botulinum toxin Type A for treatment of facial lines
Interventions
Previous treatment with botulinum toxin Type A for treatment of facial lines
Eligibility Criteria
Subjects treated for glabellar lines (hyperfunctional facial lines) with botulinum toxin Type A
You may qualify if:
- Previously treated for glabellar lines (hyperfunctional facial lines) with botulinum toxin Type A preparation
- Received 2 treatment cycles wtih botulinum toxin Type A (BOTOX®) prior to at least 1 treatment with botulinum toxin Type A (Xeomin®)
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
Buenos Aires, Argentina
Related Publications (1)
Banegas RA, Farache F, Rancati A, Chain M, Gallagher CJ, Chapman MA, Caulkins CA. The South American Glabellar Experience Study (SAGE): a multicenter retrospective analysis of real-world treatment patterns following the introduction of incobotulinumtoxinA in Argentina. Aesthet Surg J. 2013 Sep 1;33(7):1039-45. doi: 10.1177/1090820X13503475. Epub 2013 Aug 29.
PMID: 23990584BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President Medical Affairs,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2012
First Posted
May 31, 2012
Study Start
April 1, 2011
Primary Completion
June 17, 2011
Study Completion
June 17, 2011
Last Updated
April 17, 2019
Results First Posted
August 1, 2012
Record last verified: 2019-04