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Safety and Efficacy of Juvederm® VOLUMA™ for Correction of Mid-face Volume Deficiency

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan ( Allergan Medical )
ClinicalTrials.gov Identifier:
NCT01029535
First received: December 8, 2009
Last updated: October 6, 2014
Last verified: December 2013
Results First Received: May 1, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Mid-face Volume Deficiency
Intervention: Device: Juvederm® VOLUMA™

  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
Voluma Subjects receive Voluma in both sides of face at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale.

Participant Flow:   Overall Study
    Voluma  
STARTED     103  
COMPLETED     70  
NOT COMPLETED     33  
Did not continue to Phase 2                 15  
Lost to Follow-up                 11  
Protocol Violation                 3  
Withdrawal by Subject                 2  
Adverse Event                 1  
Death                 1  



  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
Voluma Subjects receive Voluma in both sides of face at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale.

Baseline Measures
    Voluma  
Number of Participants  
[units: participants]
  103  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     103  
>=65 years     0  
Gender  
[units: participants]
 
Female     83  
Male     20  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mid-face Volume Deficit Scale (MVDS)   [ Time Frame: Through Week 104 ]

2.  Secondary:   Global Aesthetic Improvement Scale (GAIS)   [ Time Frame: Through Week 104 ]

3.  Secondary:   Wrinkle Assessment Nasolabial Fold (NLF) Rating   [ Time Frame: Through Week 104 ]

4.  Secondary:   Self-Perception of Age   [ Time Frame: Through Week 104 ]

5.  Secondary:   Subject Satisfaction   [ Time Frame: At Week 104 ]


  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: Medical Monitor
Organization: Allergan Medical
phone: (805) 961-5000
e-mail: devicetrials@allergan.com


Publications:

Responsible Party: Allergan ( Allergan Medical )
ClinicalTrials.gov Identifier: NCT01029535     History of Changes
Other Study ID Numbers: VOL-AP01
Study First Received: December 8, 2009
Results First Received: May 1, 2012
Last Updated: October 6, 2014
Health Authority: Australia: Australian Therapeutic Goods Administration (TGA)