Mid-face Volume Deficiency
Conditions
Brief summary
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.
Interventions
Cross-linked hyaluronic acid gel (Juvederm® VOLUMA™) up to 4 mLs injected in each side of the face.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 104 | 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. |
| Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 104 | 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. |
| Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 52 | 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. |
| Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 78 | 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. |
| Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 104 | 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. |
| Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 52 | 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. |
| Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 78 | 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. |
| Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 4 | 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. |
| Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 8 | 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. |
| Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 4 | 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. |
| Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 8 | 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. |
| Percentage of Participants a ≥1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 4 | 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. |
| Percentage of Participants a ≥ 1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 8 | 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. |
| Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 52 | 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. |
| Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 78 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the MFVDS Score | 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. |
| Physician Assessment of Global Aesthetic Improvement Score (GAIS) | 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. |
| Subject's Assessment of Global Aesthetic Improvement Score (GAIS) | 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. |
| Change From Baseline in the Subject's Self-Perception of Age (SPA) | 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. |
| Percentage of Participants Satisfied or Very Satisfied With the Treatment | Week 8 | Participants rated their satisfaction with treatment using a 5-Point Scale where: 1=very unsatisfied to 5=very satisfied. |
| Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS) | 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. |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 103 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 24 |
| Overall Study | Participant Withdrew Consent | 2 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Use of Another Treatment | 1 |
Baseline characteristics
| Characteristic | Juvederm® VOLUMA™ |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 103 Participants |
| Age, Continuous | 46.7 years |
| Sex: Female, Male Female | 83 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 65 / 103 | 8 / 99 |
| serious Total, serious adverse events | 0 / 103 | 1 / 99 |
Outcome results
Primary
Percentage of Participants a ≥1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at 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.
Time frame: Baseline, Week 4
Population: ITT population included all enrolled participants who received at least one application of VOLUMA™.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Juvederm® VOLUMA™ | Percentage of Participants a ≥1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 4 | 92.23 percentage of particpants |
Primary
Percentage of Participants a ≥ 1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at 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.
Time frame: Baseline, Week 8
Population: Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Juvederm® VOLUMA™ | Percentage of Participants a ≥ 1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 8 | 95.96 percentage of participants |
Primary
Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at 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.
Time frame: Baseline, Week 8, Week 104
Population: ITT population included all enrolled participants who received at least one application of VOLUMA™.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Juvederm® VOLUMA™ | Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 104 | 38.8 percentage of participants |
Primary
Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at 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.
Time frame: Baseline, Week 8, Week 52
Population: ITT population included all enrolled participants who received at least one application of VOLUMA™.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Juvederm® VOLUMA™ | Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 52 | 40.8 percentage of participants |
Primary
Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at 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.
Time frame: Baseline, Week 8, Week 78
Population: ITT population included all enrolled participants who received at least one application of VOLUMA™.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Juvederm® VOLUMA™ | Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 78 | 30.1 percentage of participants |
Primary
Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at 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.
Time frame: Baseline, Week 8, Week 104
Population: ITT population included all enrolled participants who received at least one application of VOLUMA™.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Juvederm® VOLUMA™ | Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 104 | 29.1 percentage of participants |
Primary
Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at 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.
Time frame: Baseline, Week 8, Week 52
Population: ITT population included all enrolled participants who received at least one application of VOLUMA™.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Juvederm® VOLUMA™ | Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 52 | 32.0 percentage of participants |
Primary
Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at 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.
Time frame: Baseline, Week 8, Week 78
Population: ITT population included all enrolled participants who received at least one application of VOLUMA™.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Juvederm® VOLUMA™ | Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 78 | 28.2 percentage of participants |
Primary
Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at 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.
Time frame: Baseline, Week 8, Week 104
Population: ITT population included all enrolled participants who received at least one application of VOLUMA™.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Juvederm® VOLUMA™ | Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 104 | 36.9 percentage of participants |
Primary
Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at 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.
Time frame: Baseline, Week 8, Week 52
Population: ITT population included all enrolled participants who received at least one application of VOLUMA™.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Juvederm® VOLUMA™ | Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 52 | 41.7 percentage of participants |
Primary
Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at 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.
Time frame: Baseline, Week 8, Week 78
Population: ITT population included all enrolled participants who received at least one application of VOLUMA™.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Juvederm® VOLUMA™ | Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 78 | 36.9 percentage of participants |
Primary
Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at 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.
Time frame: Baseline, Week 4
Population: Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Juvederm® VOLUMA™ | Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 4 | 100 percentage of participants |
Primary
Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at 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.
Time frame: Baseline, Week 8
Population: Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Juvederm® VOLUMA™ | Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 8 | 100 percentage of particpants |
Primary
Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at 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.
Time frame: Baseline, Week 4
Population: Participants from the intent-to-treat (ITT) population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Juvederm® VOLUMA™ | Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 4 | 97.06 percentage of participants |
Primary
Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at 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.
Time frame: Baseline, Week 8
Population: Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Juvederm® VOLUMA™ | Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 8 | 97.98 percentage of participants |
Secondary
Change From Baseline in the MFVDS Score
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.
Time frame: Baseline, Weeks 4, 8, 52, 78 and 104
Population: Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Juvederm® VOLUMA™ | Change From Baseline in the MFVDS Score | Baseline | 3.45 score on a scale | Standard Deviation 0.75 |
| Juvederm® VOLUMA™ | Change From Baseline in the MFVDS Score | Change from Baseline at Week 4 | 1.58 score on a scale | Standard Deviation 0.83 |
| Juvederm® VOLUMA™ | Change From Baseline in the MFVDS Score | Change from Baseline at Week 8 (n=99) | 2.03 score on a scale | Standard Deviation 0.91 |
| Juvederm® VOLUMA™ | Change From Baseline in the MFVDS Score | Change from Baseline at Week 52 (n=68) | 1.68 score on a scale | Standard Deviation 0.95 |
| Juvederm® VOLUMA™ | Change From Baseline in the MFVDS Score | Change from Baseline at Week 78 (n=82) | 1.44 score on a scale | Standard Deviation 1.04 |
| Juvederm® VOLUMA™ | Change From Baseline in the MFVDS Score | Change from Baseline at Week 104 (n=72) | 1.72 score on a scale | Standard Deviation 0.95 |
Secondary
Change From Baseline in the Subject's Self-Perception of Age (SPA)
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.
Time frame: Baseline, Weeks 4, 8, 52, 78 and 104
Population: Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Juvederm® VOLUMA™ | Change From Baseline in the Subject's Self-Perception of Age (SPA) | Change from Baseline at Week 4 (n=101) | -3.03 years | Standard Deviation 3.45 |
| Juvederm® VOLUMA™ | Change From Baseline in the Subject's Self-Perception of Age (SPA) | Change from Baseline at Week 8 (n=98) | -3.74 years | Standard Deviation 3.99 |
| Juvederm® VOLUMA™ | Change From Baseline in the Subject's Self-Perception of Age (SPA) | Change from Baseline at Week 52 (n=68) | -3.15 years | Standard Deviation 4.48 |
| Juvederm® VOLUMA™ | Change From Baseline in the Subject's Self-Perception of Age (SPA) | Change from Baseline at Week 78 (n=82) | -2.88 years | Standard Deviation 4.09 |
| Juvederm® VOLUMA™ | Change From Baseline in the Subject's Self-Perception of Age (SPA) | Change from Baseline at Week 104 (n=72) | -3.85 years | Standard Deviation 4.01 |
Secondary
Percentage of Participants Satisfied or Very Satisfied With the Treatment
Participants rated their satisfaction with treatment using a 5-Point Scale where: 1=very unsatisfied to 5=very satisfied.
Time frame: Week 8
Population: Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Juvederm® VOLUMA™ | Percentage of Participants Satisfied or Very Satisfied With the Treatment | Very Satisfied | 66.7 percentage of participants |
| Juvederm® VOLUMA™ | Percentage of Participants Satisfied or Very Satisfied With the Treatment | Satisfied | 24.2 percentage of participants |
Secondary
Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS)
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.
Time frame: Baseline, Weeks 4, 8, 52, 78 and 104
Population: Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Juvederm® VOLUMA™ | Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS) | Left Side Week 8 (n=99) | 45.45 percentage of participants |
| Juvederm® VOLUMA™ | Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS) | Left Side Week 52 (n=68) | 36.76 percentage of participants |
| Juvederm® VOLUMA™ | Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS) | Right Side Week 104 (n=72) | 44.44 percentage of participants |
| Juvederm® VOLUMA™ | Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS) | Left Side Week 4 (n=103) | 35.92 percentage of participants |
| Juvederm® VOLUMA™ | Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS) | Left Side Week 78 (n=82) | 42.68 percentage of participants |
| Juvederm® VOLUMA™ | Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS) | Left Side Week 104 (n=72) | 48.61 percentage of participants |
| Juvederm® VOLUMA™ | Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS) | Right Side Week 4 (n=103) | 34.95 percentage of participants |
| Juvederm® VOLUMA™ | Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS) | Right Side Week 8 (n=99) | 43.43 percentage of participants |
| Juvederm® VOLUMA™ | Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS) | Right Side Week 52 (n=68) | 27.94 percentage of participants |
| Juvederm® VOLUMA™ | Percentage of Participants With a ≥ 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS) | Right Side Week 78 (n=82) | 41.46 percentage of participants |
Secondary
Physician Assessment of Global Aesthetic Improvement Score (GAIS)
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.
Time frame: Baseline, Weeks 4, 8, 52, 78 and 104
Population: Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Juvederm® VOLUMA™ | Physician Assessment of Global Aesthetic Improvement Score (GAIS) | Week 4 (n=102) | 1.35 score on a scale | Standard Deviation 0.48 |
| Juvederm® VOLUMA™ | Physician Assessment of Global Aesthetic Improvement Score (GAIS) | Week 8 (n=99) | 1.76 score on a scale | Standard Deviation 0.43 |
| Juvederm® VOLUMA™ | Physician Assessment of Global Aesthetic Improvement Score (GAIS) | Week 52 (n=68) | 1.13 score on a scale | Standard Deviation 0.81 |
| Juvederm® VOLUMA™ | Physician Assessment of Global Aesthetic Improvement Score (GAIS) | Week 78 (n=82) | 0.85 score on a scale | Standard Deviation 0.9 |
| Juvederm® VOLUMA™ | Physician Assessment of Global Aesthetic Improvement Score (GAIS) | Week 104 (n=72) | 1.14 score on a scale | Standard Deviation 0.74 |
Secondary
Subject's Assessment of Global Aesthetic Improvement Score (GAIS)
The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved.
Time frame: Baseline, Weeks 4, 8, 52, 78 and 104
Population: Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Juvederm® VOLUMA™ | Subject's Assessment of Global Aesthetic Improvement Score (GAIS) | Week 4 (n=102) | 1.31 score on a scale | Standard Deviation 0.52 |
| Juvederm® VOLUMA™ | Subject's Assessment of Global Aesthetic Improvement Score (GAIS) | Week 8 (n=99) | 1.55 score on a scale | Standard Deviation 0.61 |
| Juvederm® VOLUMA™ | Subject's Assessment of Global Aesthetic Improvement Score (GAIS) | Week 52 (n=68) | 1.01 score on a scale | Standard Deviation 0.86 |
| Juvederm® VOLUMA™ | Subject's Assessment of Global Aesthetic Improvement Score (GAIS) | Week 78 (n=82) | 0.79 score on a scale | Standard Deviation 0.94 |
| Juvederm® VOLUMA™ | Subject's Assessment of Global Aesthetic Improvement Score (GAIS) | Week 104 (n=72) | 0.97 score on a scale | Standard Deviation 0.77 |