An Observational Retrospective Study to Evaluate Treatment Patterns of Botulinum Toxin Type A

Facial Rhytides Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01608659
• Other study ID #: GMA-BTXC-10-001
• Status: Completed
• Start date: April 1, 2011
• Est. completion date: June 17, 2011

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a retrospective chart review to evaluate treatment patterns of botulinum toxin Type A for the treatment of facial lines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 17, 2011
• Est. primary completion date: June 17, 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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®)

Exclusion Criteria:

Related Conditions & MeSH terms

• Facial Rhytides

Intervention

Drug:
• botulinum toxin Type A
Previous treatment with botulinum toxin Type A for treatment of facial lines

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Argentina, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Inter-Injection Interval Duration of Each Treatment Period	Inter-injection interval duration of each treatment period. Duration is defined as the number of days of an injection cycle.	24 Months
Secondary	Percent of Subjects Reporting Satisfaction With Treatment Effects	Percent of subjects reporting satisfaction with treatment effects per chart notes.	24 Months