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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
History of Changes
  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:

MedlinePlus related topics: Botox
U.S. FDA Resources

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
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:

  • None
  Contacts and Locations
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

No publications provided

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
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013