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
Results First Received: June 25, 2012  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Retrospective
Condition: Facial Rhytides
Intervention: Drug: botulinum toxin Type A

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In this retrospective chart review study, subjects received botulinum toxin Type A (BOTOX®) in study-defined Treatment Periods 1 and 3, and botulinum toxin Type A (Xeomin®) in Treatment Period 2. Data were evaluated as available for each Treatment Period.

Reporting Groups
  Description
Botulinum Toxin Type A Previous treatment with botulinum toxin Type A for treatment of facial lines

Participant Flow:   Overall Study
    Botulinum Toxin Type A  
STARTED     110  
COMPLETED     94  
NOT COMPLETED     16  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Botulinum Toxin Type A Previous treatment with botulinum toxin Type A for treatment of facial lines

Baseline Measures
    Botulinum Toxin Type A  
Number of Participants  
[units: participants]
  110  
Age, Customized  
[units: Participants]
 
≥30 and <40 years     5  
≥40 and <50 years     31  
≥50 and <60 years     33  
≥60 years     35  
Missing     6  
Gender  
[units: Participants]
 
Female     110  
Male     0  



  Outcome Measures
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1.  Primary:   Average Total Dose Per Treatment Period   [ Time Frame: 24 Months ]

2.  Secondary:   Inter-Injection Interval Duration of Each Treatment Period   [ Time Frame: 24 Months ]

3.  Secondary:   Percent of Subjects Reporting Satisfaction With Treatment Effects   [ Time Frame: 24 Months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Vice President Medical Affairs,
Organization: Allergan, Inc
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com


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