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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
ClinicalTrials.gov Identifier:
NCT01029535
First received: December 8, 2009
Last updated: February 8, 2016
Last verified: February 2016
Results First Received: May 1, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Mid-face Volume Deficiency
Intervention: Device: Cross-linked hyaluronic acid gel

  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
Juvederm® VOLUMA™ Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.

Participant Flow:   Overall Study
    Juvederm® VOLUMA™  
STARTED     103  
COMPLETED     72  
NOT COMPLETED     31  
Lost to Follow-up                 24  
Protocol Violation                 2  
Participant Withdrew Consent                 2  
Adverse Event                 1  
Use of Another Treatment                 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
Juvederm® VOLUMA™ Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.

Baseline Measures
    Juvederm® VOLUMA™  
Number of Participants  
[units: participants]
  103  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     103  
>=65 years     0  
Age  
[units: years]
Mean (Full Range)
  46.7  
  (29 to 63)  
Gender  
[units: participants]
 
Female     83  
Male     20  



  Outcome Measures
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1.  Primary:   Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject’s Global Aesthetic Improvement Scale (GAIS) at Week 4   [ Time Frame: Baseline, Week 4 ]

2.  Primary:   Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject’s Global Aesthetic Improvement Scale (GAIS) at Week 8   [ Time Frame: Baseline, Week 8 ]

3.  Primary:   Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician’s Global Aesthetic Improvement Scale (GAIS) at Week 4   [ Time Frame: Baseline, Week 4 ]

4.  Primary:   Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician’s Global Aesthetic Improvement Scale (GAIS) at Week 8   [ Time Frame: Baseline, Week 8 ]

5.  Primary:   Percentage of Participants a ≥1 Point Improvement From Baseline in the Physician’s Mid-face Volume Deficit Scale (MFVDS) at Week 4   [ Time Frame: Baseline, Week 4 ]

6.  Primary:   Percentage of Participants a ≥ 1 Point Improvement From Baseline in the Physician’s Mid-face Volume Deficit Scale (MFVDS) at Week 8   [ Time Frame: Baseline, Week 8 ]

7.  Primary:   Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 52   [ Time Frame: Baseline, Week 8, Week 52 ]

8.  Primary:   Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 78   [ Time Frame: Baseline, Week 8, Week 78 ]

9.  Primary:   Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 104   [ Time Frame: Baseline, Week 8, Week 104 ]

10.  Primary:   Percentage of Participants Who Maintained Their Week 8 Subject’s GAIS Scores at Week 52   [ Time Frame: Baseline, Week 8, Week 52 ]

11.  Primary:   Percentage of Participants Who Maintained Their Week 8 Subject’s GAIS Scores at Week 78   [ Time Frame: Baseline, Week 8, Week 78 ]

12.  Primary:   Percentage of Participants Who Maintained Their Week 8 Subject’s GAIS Scores at Week 104   [ Time Frame: Baseline, Week 8, Week 104 ]

13.  Primary:   Percentage of Participants Who Maintained Their Week 8 Physician’s GAIS Scores at Week 52   [ Time Frame: Baseline, Week 8, Week 52 ]

14.  Primary:   Percentage of Participants Who Maintained Their Week 8 Physician’s GAIS Scores at Week 78   [ Time Frame: Baseline, Week 8, Week 78 ]

15.  Primary:   Percentage of Participants Who Maintained Their Week 8 Physician’s GAIS Scores at Week 104   [ Time Frame: Baseline, Week 8, Week 104 ]

16.  Secondary:   Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator’s Wrinkle Assessment Scale (WAS)   [ Time Frame: Baseline, Weeks 4, 8, 52, 78 and 104 ]

17.  Secondary:   Change From Baseline in the MFVDS Score   [ Time Frame: Baseline, Weeks 4, 8, 52, 78 and 104 ]

18.  Secondary:   Physician Assessment of Global Aesthetic Improvement Score (GAIS)   [ Time Frame: Baseline, Weeks 4, 8, 52, 78 and 104 ]

19.  Secondary:   Subject’s Assessment of Global Aesthetic Improvement Score (GAIS)   [ Time Frame: Baseline, Weeks 4, 8, 52, 78 and 104 ]

20.  Secondary:   Change From Baseline in the Subject’s Self-Perception of Age (SPA)   [ Time Frame: Baseline, Weeks 4, 8, 52, 78 and 104 ]

21.  Secondary:   Percentage of Participants Satisfied or Very Satisfied With the Treatment   [ Time Frame: Week 8 ]


  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: Vice President Medical Affairs,
Organization: Allergan, Inc
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com


Publications:

Responsible Party: Allergan
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: February 8, 2016
Health Authority: Australia: Australian Therapeutic Goods Administration (TGA)