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

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ClinicalTrials.gov Identifier: NCT01608659
Recruitment Status : Completed
First Posted : May 31, 2012
Results First Posted : August 1, 2012
Last Update Posted : August 1, 2012
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Condition or disease Intervention/treatment
Facial Rhytides Drug: botulinum toxin Type A

Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Study Start Date : April 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Group/Cohort Intervention/treatment
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®




Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. Percent of Subjects Reporting Satisfaction With Treatment Effects [ Time Frame: 24 Months ]
    Percent of subjects reporting satisfaction with treatment effects per chart notes.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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:


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

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01608659     History of Changes
Other Study ID Numbers: GMA-BTXC-10-001
First Posted: May 31, 2012    Key Record Dates
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