Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01224015
First received: October 18, 2010
Last updated: February 24, 2014
Last verified: February 2014
Results First Received: September 27, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Facial Rhytides
Crow's Feet Lines
Glabellar Lines
Interventions: Drug: normal saline
Biological: onabotulinumtoxinA 44 U
Biological: onabotulinumtoxinA 24 U

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Extension study for patients who participated in study 191622-099

Reporting Groups
  Description
onabotulinumtoxinA 44U 44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
onabotulinumtoxinA 24U 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
Placebo (Normal Saline) Normal Saline injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.

Participant Flow:   Overall Study
    onabotulinumtoxinA 44U     onabotulinumtoxinA 24U     Placebo (Normal Saline)  
STARTED     361     227     96  
COMPLETED     347     211     83  
NOT COMPLETED     14     16     13  



  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.
No text entered.

Reporting Groups
  Description
onabotulinumtoxinA 44U 44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
onabotulinumtoxinA 24U 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
Placebo (Normal Saline) Normal Saline injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
Total Total of all reporting groups

Baseline Measures
    onabotulinumtoxinA 44U     onabotulinumtoxinA 24U     Placebo (Normal Saline)     Total  
Number of Participants  
[units: participants]
  361     227     96     684  
Age, Customized  
[units: Participants]
       
<45 Years     105     68     33     206  
45 to 65 Years     241     148     59     448  
>65 Years     15     11     4     30  
Gender  
[units: Participants]
       
Female     315     203     80     598  
Male     46     24     16     86  



  Outcome Measures

1.  Primary:   Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines   [ Time Frame: Day 30 ]


  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: Therapeutic Area Head,
Organization: Allergan, Inc
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com


No publications provided


Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01224015     History of Changes
Other Study ID Numbers: 191622-104, 2010-021271-83
Study First Received: October 18, 2010
Results First Received: September 27, 2013
Last Updated: February 24, 2014
Health Authority: United States: Food and Drug Administration