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Safety and Effectiveness of Juvéderm® VOLUMA XC Injectable Gel for Cheek Augmentation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan ( Allergan Medical )
ClinicalTrials.gov Identifier:
NCT00978042
First received: September 15, 2009
Last updated: October 6, 2014
Last verified: June 2014
Results First Received: November 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Outcomes Assessor)
Condition: Mid-facial Volume Deficit Related to Aging
Intervention: Device: Juvéderm® VOLUMA XC

  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
345 subject were originally recruited for treatment at 15 sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to randomization, 16 subjects were excluded as screen failures and the first two subjects per site (30 total) were treated as run-in subjects. Of the 299 randomized subjects, 17 were discontinued prior to treatment, leaving a “modified intent-to-treat” population of 282 subjects (235 in Treatment Arm and 47 in Control Arm).

Reporting Groups
  Description
Treatment Arm Subjects treated in the initial treatment window
Control Arm Subjects treated after the 6-month primary follow-up period

Participant Flow:   Overall Study
    Treatment Arm     Control Arm  
STARTED     235     47  
COMPLETED     174 [1]   31 [1]
NOT COMPLETED     61     16  
[1] Completed 24-month Follow-Up



  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
Treatment Arm Subjects treated in the initial treatment window
Control Arm Subjects treated after the 6-month primary follow-up period
Total Total of all reporting groups

Baseline Measures
    Treatment Arm     Control Arm     Total  
Number of Participants  
[units: participants]
  235     47     282  
Age  
[units: years]
Mean ± Standard Deviation
  54.4  ± 7.18     54.7  ± 5.95     54.4  ± 6.98  
Gender  
[units: participants]
     
Female     189     37     226  
Male     46     10     56  
Region of Enrollment  
[units: participants]
     
United States     208     41     249  
Canada     27     6     33  



  Outcome Measures
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1.  Primary:   Responder Rate Based on Improvement in Score on Validated 6-point Mid-Face Volume Deficit Scale (MFVDS)   [ Time Frame: 6 months ]

2.  Secondary:   Duration of Treatment Effect   [ Time Frame: 24 months ]


  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
None


  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, Inc.
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com


Publications of Results:

Responsible Party: Allergan ( Allergan Medical )
ClinicalTrials.gov Identifier: NCT00978042     History of Changes
Other Study ID Numbers: VOLUMA-002
Study First Received: September 15, 2009
Results First Received: November 22, 2013
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration