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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:
NCT01189760
First received: August 25, 2010
Last updated: September 27, 2013
Last verified: September 2013
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: Biological: onabotulinumtoxinA 24 U
Biological: onabotulinumtoxinA 44 U
Drug: normal saline

  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
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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 two treatments 4 months apart.
onabotulinumtoxinA 24U 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
Placebo (Normal Saline) Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.

Participant Flow:   Overall Study
    onabotulinumtoxinA 44U     onabotulinumtoxinA 24U     Placebo (Normal Saline)  
STARTED     305     306     306  
COMPLETED     291     283     255  
NOT COMPLETED     14     23     51  



  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
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 two treatments 4 months apart.
onabotulinumtoxinA 24U 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
Placebo (Normal Saline) Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
Total Total of all reporting groups

Baseline Measures
    onabotulinumtoxinA 44U     onabotulinumtoxinA 24U     Placebo (Normal Saline)     Total  
Number of Participants  
[units: participants]
  305     306     306     917  
Age, Customized  
[units: Participants]
       
<45 Years     87     89     100     276  
45 to 65 Years     204     200     194     598  
>65 Years     14     17     12     43  
Gender  
[units: Participants]
       
Female     267     273     263     803  
Male     38     33     43     114  
CFL Severity as Assessed by the Investigator [1]
[units: Participants]
       
Moderate     109     115     113     337  
Severe     196     191     193     580  
[1] Crow’s Feet Line (CFL) severity as assessed at Baseline by the Investigator using the 4-point Facial Wrinkle Scale (FWS) at maximum smile.



  Outcome Measures
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1.  Primary:   Percentage of Responders Based on Composite Facial Wrinkle Scale Assessment of Crow's Feet Line Severity at Maximum Smile   [ Time Frame: Baseline, Day 30 ]

2.  Secondary:   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 ]

3.  Secondary:   Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow’s Feet Lines at Maximum Smile   [ Time Frame: Baseline, Day 30 ]

4.  Secondary:   Percentage of Participants With a ≥ 1-Grade Improvement From Baseline by Investigator Facial Wrinkle Scale Assessment of the Severity of Crow’s Feet Lines at Rest   [ Time Frame: Baseline, Day 30 ]

5.  Secondary:   Subject Global Assessment of Change in Crow’s Feet Lines (SGA-CFL) Score   [ Time Frame: Day 30 ]

6.  Secondary:   Percentage of Participants Who Judged Themselves in a Younger Self-Perception of Age Category Than at Baseline   [ Time Frame: Baseline, Day 30 ]

7.  Secondary:   Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30   [ Time Frame: Baseline, Day 30 ]

8.  Secondary:   Percentage of Participants With a ≥ 2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30   [ Time Frame: Baseline, Day 30 ]

9.  Secondary:   Percentage of Participants With a ≥ 3-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30   [ Time Frame: Baseline, Day 30 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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.


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: NCT01189760     History of Changes
Other Study ID Numbers: 191622-099
Study First Received: August 25, 2010
Results First Received: September 27, 2013
Last Updated: September 27, 2013
Health Authority: United States: Food and Drug Administration