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 Medical
ClinicalTrials.gov Identifier:
NCT01029535
First received: December 8, 2009
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

This is a prospective, open-label experience study to be conducted at 6 clinical sites in Australia, with the objective to collect efficacy and safety information for Juvederm® VOLUMA™ when used for volumising the mid-face and cheek area.


Condition Intervention
Mid-face Volume Deficiency
Device: Juvederm® VOLUMA™

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Allergan Medical:

Primary Outcome Measures:
  • Mid-face Volume Deficit Scale (MVDS) [ Time Frame: Through Week 104 ] [ Designated as safety issue: No ]
    Percent of subjects maintaining >=1 grade improvement from baseline based on 6-point MVDS scale ranging from 0 (no facial volume loss) to 5 (severe volume loss)


Secondary Outcome Measures:
  • Global Aesthetic Improvement Scale (GAIS) [ Time Frame: Through Week 104 ] [ Designated as safety issue: No ]
    Percent of subjects maintaining >= 1 grade improvement from Week 8 based on the 5-point GAIS scale (-2 to =+2) where negative numbers indicate worse outcome, 0 indicates no change, and positive numbers indicate improvement

  • Wrinkle Assessment Nasolabial Fold (NLF) Rating [ Time Frame: Through Week 104 ] [ Designated as safety issue: No ]
    Percentage of subjects with >= 1 point improvement on a 5-point scale assessing nasolabial fold severity where 0 is not wrinkle and 4 is a very deep wrinkle

  • Self-Perception of Age [ Time Frame: Through Week 104 ] [ Designated as safety issue: No ]
    Change in self-perception of age compared to baseline

  • Subject Satisfaction [ Time Frame: At Week 104 ] [ Designated as safety issue: No ]
    Percentage of subjects responding "satisfied" or "very satisfied" with the treatment


Enrollment: 103
Study Start Date: January 2009
Study Completion Date: October 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Voluma
Subjects receive Voluma 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.
Device: Juvederm® VOLUMA™
cross-linked hyaluronic acid injectable implant

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with mild to severe mid-face and cheek volume deficit due to age-related changes, who are likely to improve by at least 2 grades following treatment with the study compound, based on a study-specific scale, as assessed by the study physician

Exclusion Criteria:

  • Subjects who have a pre-existing medical condition or who have received any treatments or procedures which may impact on the assessment of the effects of the study compound.
  • Subjects with a history of allergies or other side effects to dermal fillers, lidocaine, hyaluronic acid or other component of the study compound.
  • Subjects were are pregnant or breast-feeding or who are of child-bearing potential and who are not prepared to practice an adequate form of contraception during the course of the study
  • Subjects with a history of alcoholism or drug abuse or dependence
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029535

Locations
Australia
Sydney, Australia
Sponsors and Collaborators
Allergan Medical
  More Information

Publications:
Responsible Party: 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: December 23, 2013
Health Authority: Australia: Australian Therapeutic Goods Administration (TGA)

ClinicalTrials.gov processed this record on September 30, 2014