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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
ClinicalTrials.gov Identifier:
NCT00978042
First received: September 15, 2009
Last updated: September 25, 2015
Last verified: September 2015
Results First Received: November 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel 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 participants 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 patients were excluded as screen failures and the first two participants per site (30 total) were treated as run-in participants. Of the 299 randomized participants, 17 were discontinued prior to treatment, leaving a “modified intent-to-treat” population of 282 participants (235 in Treatment Arm and 47 in Control Arm).

Reporting Groups
  Description
VOLUMA® XC Treatment Arm Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
Control Arm_No Treatment Then VOLUMA® XC No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.

Participant Flow for 2 periods

Period 1:   Initial Treatment Period
    VOLUMA® XC Treatment Arm   Control Arm_No Treatment Then VOLUMA® XC
STARTED   235   47 
MITT_treated With VOLUMA XC   235   35 
COMPLETED   174 [1]   32 
NOT COMPLETED   61   15 
Treated in Error                0                3 
Ineligibility                1                0 
Lost to Follow-up                21                3 
Adverse Event                2                0 
Discontinuation by Investigator/Sponsor                2                0 
Consent withdrawn                22                9 
Other Miscellaneous Reasons                13                0 
[1] Completed 24-month Follow-Up

Period 2:   Received Repeat Treatment
    VOLUMA® XC Treatment Arm   Control Arm_No Treatment Then VOLUMA® XC
STARTED   141 [1]   26 [1] 
COMPLETED   98 [2]   23 
NOT COMPLETED   43   3 
[1] Participants who were deemed eligible for re-treatment.
[2] Completed=Completed Repeat Treatment 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
VOLUMA® XC Treatment Arm Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
Control Arm_No Treatment Then VOLUMA® XC No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
Total Total of all reporting groups

Baseline Measures
   VOLUMA® XC Treatment Arm   Control Arm_No Treatment Then VOLUMA® XC   Total 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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 ]

3.  Secondary:   Responder Rate Based on Improvement in Score on Global Aesthetic Improvement Scale (GAIS)   [ Time Frame: 6 months ]

4.  Secondary:   Responder Rate Based on Improvement in Score on MFVDS by Facial Region   [ Time Frame: 6 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
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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


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Allergan
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: September 25, 2015
Health Authority: United States: Food and Drug Administration