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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
  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: Cross-linked hyaluronic acid gel

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

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale where:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.

  • 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 ] [ Designated as safety issue: No ]
    The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.

  • 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 ] [ Designated as safety issue: No ]
    The physician rated the participant's midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.

  • 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 ] [ Designated as safety issue: No ]
    The physician rated the participant's midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported.

  • 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 ] [ Designated as safety issue: No ]
    The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS: 0=no facial volume loss to 5=severe volume loss.

  • 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 ] [ Designated as safety issue: No ]
    The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS: 0=no facial volume loss to 5=severe volume loss.

  • Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 52 [ Time Frame: Baseline, Week 8, Week 52 ] [ Designated as safety issue: No ]
    The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 52, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.

  • Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 78 [ Time Frame: Baseline, Week 8, Week 78 ] [ Designated as safety issue: No ]
    The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 78, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.

  • Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 104 [ Time Frame: Baseline, Week 8, Week 104 ] [ Designated as safety issue: No ]
    The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 104, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported.

  • Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 52 [ Time Frame: Baseline, Week 8, Week 52 ] [ Designated as safety issue: No ]
    The participant rated their midface appearance compared to before treatment at Week 8 and Week 52 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.

  • Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 78 [ Time Frame: Baseline, Week 8, Week 78 ] [ Designated as safety issue: No ]
    The participant rated their midface appearance compared to before treatment at Week 8 and Week 78 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.

  • Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 104 [ Time Frame: Baseline, Week 8, Week 104 ] [ Designated as safety issue: No ]
    The participant rated their midface appearance compared to before treatment at Week 8 and Week 104 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.

  • Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 52 [ Time Frame: Baseline, Week 8, Week 52 ] [ Designated as safety issue: No ]
    The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 52 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.

  • Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 78 [ Time Frame: Baseline, Week 8, Week 78 ] [ Designated as safety issue: No ]
    The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 78 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.

  • Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 104 [ Time Frame: Baseline, Week 8, Week 104 ] [ Designated as safety issue: No ]
    The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 104 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The physician assessed the left side and the right side of the participant's face for severity of nasolabial folds using the 5-point WAS where: 0=no wrinkle to 4=very deep wrinkle.

  • Change From Baseline in the MFVDS Score [ Time Frame: Baseline, Weeks 4, 8, 52, 78 and 104 ] [ Designated as safety issue: No ]
    The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS where: 0=no facial volume loss to 5=severe volume loss. A negative change from Baseline indicates improvement.

  • Physician Assessment of Global Aesthetic Improvement Score (GAIS) [ Time Frame: Baseline, Weeks 4, 8, 52, 78 and 104 ] [ Designated as safety issue: No ]
    The physician rated the participant's midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved.

  • Subject's Assessment of Global Aesthetic Improvement Score (GAIS) [ Time Frame: Baseline, Weeks 4, 8, 52, 78 and 104 ] [ Designated as safety issue: No ]
    The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved.

  • Change From Baseline in the Subject's Self-Perception of Age (SPA) [ Time Frame: Baseline, Weeks 4, 8, 52, 78 and 104 ] [ Designated as safety issue: No ]
    The participant rated their facial age in years at Baseline and Weeks 4, 8, 52, 78 and 104. A negative change from Baseline indicates an improvement.

  • Percentage of Participants Satisfied or Very Satisfied With the Treatment [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Participants rated their satisfaction with treatment using a 5-Point Scale where: 1=very unsatisfied to 5=very satisfied.


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: 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.
Device: Cross-linked hyaluronic acid gel
Cross-linked hyaluronic acid gel (Juvederm® VOLUMA™) up to 4 mLs injected in each side of the face.
Other Name: Juvederm® VOLUMA™

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years   (Adult)
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
Investigators
Study Director: Medical Director Allergan
  More Information

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)

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on September 26, 2016