Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01029535




Registration number
NCT01029535
Ethics application status
Date submitted
8/12/2009
Date registered
10/12/2009
Date last updated
9/03/2016

Titles & IDs
Public title
Safety and Efficacy of Juvederm® VOLUMA™ for Correction of Mid-face Volume Deficiency
Scientific title
Secondary ID [1] 0 0
VOL-AP01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mid-face Volume Deficiency 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Cross-linked hyaluronic acid gel

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.


Treatment: Devices: Cross-linked hyaluronic acid gel
Cross-linked hyaluronic acid gel (Juvederm® VOLUMA™) up to 4 mLs injected in each side of the face.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With a = 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 4
Timepoint [1] 0 0
Baseline, Week 4
Primary outcome [2] 0 0
Percentage of Participants With a = 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 8
Timepoint [2] 0 0
Baseline, Week 8
Primary outcome [3] 0 0
Percentage of Participants With a = 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 4
Timepoint [3] 0 0
Baseline, Week 4
Primary outcome [4] 0 0
Percentage of Participants With a = 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 8
Timepoint [4] 0 0
Baseline, Week 8
Primary outcome [5] 0 0
Percentage of Participants a =1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 4
Timepoint [5] 0 0
Baseline, Week 4
Primary outcome [6] 0 0
Percentage of Participants a = 1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 8
Timepoint [6] 0 0
Baseline, Week 8
Primary outcome [7] 0 0
Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 52
Timepoint [7] 0 0
Baseline, Week 8, Week 52
Primary outcome [8] 0 0
Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 78
Timepoint [8] 0 0
Baseline, Week 8, Week 78
Primary outcome [9] 0 0
Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 104
Timepoint [9] 0 0
Baseline, Week 8, Week 104
Primary outcome [10] 0 0
Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 52
Timepoint [10] 0 0
Baseline, Week 8, Week 52
Primary outcome [11] 0 0
Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 78
Timepoint [11] 0 0
Baseline, Week 8, Week 78
Primary outcome [12] 0 0
Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 104
Timepoint [12] 0 0
Baseline, Week 8, Week 104
Primary outcome [13] 0 0
Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 52
Timepoint [13] 0 0
Baseline, Week 8, Week 52
Primary outcome [14] 0 0
Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 78
Timepoint [14] 0 0
Baseline, Week 8, Week 78
Primary outcome [15] 0 0
Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 104
Timepoint [15] 0 0
Baseline, Week 8, Week 104
Secondary outcome [1] 0 0
Percentage of Participants With a = 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS)
Timepoint [1] 0 0
Baseline, Weeks 4, 8, 52, 78 and 104
Secondary outcome [2] 0 0
Change From Baseline in the MFVDS Score
Timepoint [2] 0 0
Baseline, Weeks 4, 8, 52, 78 and 104
Secondary outcome [3] 0 0
Physician Assessment of Global Aesthetic Improvement Score (GAIS)
Timepoint [3] 0 0
Baseline, Weeks 4, 8, 52, 78 and 104
Secondary outcome [4] 0 0
Subject's Assessment of Global Aesthetic Improvement Score (GAIS)
Timepoint [4] 0 0
Baseline, Weeks 4, 8, 52, 78 and 104
Secondary outcome [5] 0 0
Change From Baseline in the Subject's Self-Perception of Age (SPA)
Timepoint [5] 0 0
Baseline, Weeks 4, 8, 52, 78 and 104
Secondary outcome [6] 0 0
Percentage of Participants Satisfied or Very Satisfied With the Treatment
Timepoint [6] 0 0
Week 8

Eligibility
Key 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
Minimum age
30 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2011
Sample size
Target
Accrual to date
Final
103
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01029535