Inter-rater and Intra-rater Reliability of the Global Eyebrow Assessment Scale

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01412086
First received: August 5, 2011
Last updated: September 27, 2012
Last verified: September 2012
Results First Received: September 27, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Healthy Volunteers
Intervention: Drug: No Intervention

  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
All Participants Healthy volunteers. No treatment (intervention) was received.

Participant Flow:   Overall Study
    All Participants  
STARTED     112  
COMPLETED     112  
NOT COMPLETED     0  



  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
All Participants Healthy volunteers. No treatment (intervention) was received.

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  112  
Age  
[units: Years]
Mean ( Full Range )
  44.3  
  ( 18 to 67 )  
Gender  
[units: Participants]
 
Female     81  
Male     31  



  Outcome Measures
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1.  Primary:   Inter-rater Reliability of Physician Raters Using the Global Eyebrow Assessment (GEBA) Scale   [ Time Frame: Day 1 ]

2.  Primary:   Intra-rater Reliability of Physician Raters Using the Global Eyebrow Assessment (GEBA) Scale   [ Time Frame: Day 1 ]


  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
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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: NCT01412086     History of Changes
Other Study ID Numbers: 192024-068
Study First Received: August 5, 2011
Results First Received: September 27, 2012
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration