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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01608659
First received: May 29, 2012
Last updated: June 25, 2012
Last verified: June 2012
  Purpose
This is a retrospective chart review to evaluate treatment patterns of botulinum toxin Type A for the treatment of facial lines.

Condition Intervention
Facial Rhytides
Drug: botulinum toxin Type A

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Average Total Dose Per Treatment Period [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    Average total dose per treatment period was defined as total treatment dose plus total touch-up dose plus total follow-up dose.


Secondary Outcome Measures:
  • Inter-Injection Interval Duration of Each Treatment Period [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    Inter-injection interval duration of each treatment period. Duration is defined as the number of days of an injection cycle.

  • Percent of Subjects Reporting Satisfaction With Treatment Effects [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    Percent of subjects reporting satisfaction with treatment effects per chart notes.


Enrollment: 110
Study Start Date: April 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
botulinum toxin Type A
Previous treatment with botulinum toxin Type A for treatment of facial lines
Drug: botulinum toxin Type A
Previous treatment with botulinum toxin Type A for treatment of facial lines
Other Names:
  • BOTOX®
  • Xeomin®

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects treated for glabellar lines (hyperfunctional facial lines) with botulinum toxin Type A
Criteria

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608659

Locations
Argentina
Buenos Aires, Argentina
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01608659     History of Changes
Other Study ID Numbers: GMA-BTXC-10-001 
Study First Received: May 29, 2012
Results First Received: June 25, 2012
Last Updated: June 25, 2012
Health Authority: Argentina: Ministry of Health

Additional relevant MeSH terms:
Botulinum Toxins, Type A
IncobotulinumtoxinA
AbobotulinumtoxinA
OnabotulinumtoxinA
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 29, 2016