Trial Review

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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
NA
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
NA
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