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
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 April 17, 2014