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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01608659
First Posted: May 31, 2012
Last Update Posted: August 1, 2012
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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: May 29, 2012
First Posted: May 31, 2012
Results First Submitted: June 25, 2012
Results First Posted: August 1, 2012
Last Update Posted: August 1, 2012
Last Verified: June 2012

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