Safety and Efficacy of Juvederm® VOLUMA™ for Correction of Mid-face Volume Deficiency

February 8, 2016 updated by: Allergan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Juvederm® VOLUMA™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Baseline, Week 4
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
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.
Baseline, Week 8
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
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.
Baseline, Week 4
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
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.
Baseline, Week 8
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
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.
Baseline, Week 4
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
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.
Baseline, Week 8
Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 52
Time Frame: Baseline, Week 8, Week 52
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.
Baseline, Week 8, Week 52
Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 78
Time Frame: Baseline, Week 8, Week 78
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.
Baseline, Week 8, Week 78
Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 104
Time Frame: Baseline, Week 8, Week 104
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.
Baseline, Week 8, Week 104
Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 52
Time Frame: Baseline, Week 8, Week 52
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.
Baseline, Week 8, Week 52
Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 78
Time Frame: Baseline, Week 8, Week 78
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.
Baseline, Week 8, Week 78
Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 104
Time Frame: Baseline, Week 8, Week 104
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.
Baseline, Week 8, Week 104
Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 52
Time Frame: Baseline, Week 8, Week 52
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.
Baseline, Week 8, Week 52
Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 78
Time Frame: Baseline, Week 8, Week 78
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.
Baseline, Week 8, Week 78
Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 104
Time Frame: Baseline, Week 8, Week 104
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.
Baseline, Week 8, Week 104

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Baseline, Weeks 4, 8, 52, 78 and 104
Change From Baseline in the MFVDS Score
Time Frame: Baseline, Weeks 4, 8, 52, 78 and 104
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.
Baseline, Weeks 4, 8, 52, 78 and 104
Physician Assessment of Global Aesthetic Improvement Score (GAIS)
Time Frame: Baseline, Weeks 4, 8, 52, 78 and 104
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.
Baseline, Weeks 4, 8, 52, 78 and 104
Subject's Assessment of Global Aesthetic Improvement Score (GAIS)
Time Frame: Baseline, Weeks 4, 8, 52, 78 and 104
The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved.
Baseline, Weeks 4, 8, 52, 78 and 104
Change From Baseline in the Subject's Self-Perception of Age (SPA)
Time Frame: Baseline, Weeks 4, 8, 52, 78 and 104
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.
Baseline, Weeks 4, 8, 52, 78 and 104
Percentage of Participants Satisfied or Very Satisfied With the Treatment
Time Frame: Week 8
Participants rated their satisfaction with treatment using a 5-Point Scale where: 1=very unsatisfied to 5=very satisfied.
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

December 8, 2009

First Submitted That Met QC Criteria

December 9, 2009

First Posted (ESTIMATE)

December 10, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 9, 2016

Last Update Submitted That Met QC Criteria

February 8, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VOL-AP01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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