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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Juvederm® VOLUMA™ | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cross-linked hyaluronic acid gel | Device | Cross-linked hyaluronic acid gel (Juvederm® VOLUMA™) up to 4 mLs injected in each side of the face. |
|
| 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 | 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 | 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 | 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 | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Weeks 4, 8, 52, 78 and 104 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sydney | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23687448 | Background | Callan P, Goodman GJ, Carlisle I, Liew S, Muzikants P, Scamp T, Halstead MB, Rogers JD. Efficacy and safety of a hyaluronic acid filler in subjects treated for correction of midface volume deficiency: a 24 month study. Clin Cosmet Investig Dermatol. 2013 Mar 20;6:81-9. doi: 10.2147/CCID.S40581. Print 2013. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants from the intent-to-treat (ITT) population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis. | Posted | Number | percentage of participants | Baseline, Week 4 |
|
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4 Participants did not complete Week 8 of Phase 1 and were not eligible for Phase 2.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Juvederm® VOLUMA™_Phase 1 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial swelling | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Contusion | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| 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. |
| Baseline, Weeks 4, 8, 52, 78 and 104 |
| 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. | Baseline, Weeks 4, 8, 52, 78 and 104 |
| 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. | Baseline, Weeks 4, 8, 52, 78 and 104 |
| 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. | Baseline, Weeks 4, 8, 52, 78 and 104 |
| 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. | Week 8 |
| Adverse Event |
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| Use of Another Treatment |
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| Death |
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| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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. | Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis. | Posted | Number | percentage of participants | Baseline, Week 8 |
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| 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. | Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis. | Posted | Number | percentage of participants | Baseline, Week 4 |
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| 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. | Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis. | Posted | Number | percentage of particpants | Baseline, Week 8 |
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| 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. | ITT population included all enrolled participants who received at least one application of VOLUMA™. | Posted | Number | percentage of particpants | Baseline, Week 4 |
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| 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. | Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis. | Posted | Number | percentage of participants | Baseline, Week 8 |
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| 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. | ITT population included all enrolled participants who received at least one application of VOLUMA™. | Posted | Number | percentage of participants | Baseline, Week 8, Week 52 |
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| 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. | ITT population included all enrolled participants who received at least one application of VOLUMA™. | Posted | Number | percentage of participants | Baseline, Week 8, Week 78 |
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| 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. | ITT population included all enrolled participants who received at least one application of VOLUMA™. | Posted | Number | percentage of participants | Baseline, Week 8, Week 104 |
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| 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. | ITT population included all enrolled participants who received at least one application of VOLUMA™. | Posted | Number | percentage of participants | Baseline, Week 8, Week 52 |
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| 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. | ITT population included all enrolled participants who received at least one application of VOLUMA™. | Posted | Number | percentage of participants | Baseline, Week 8, Week 78 |
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| 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. | ITT population included all enrolled participants who received at least one application of VOLUMA™. | Posted | Number | percentage of participants | Baseline, Week 8, Week 104 |
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| 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. | ITT population included all enrolled participants who received at least one application of VOLUMA™. | Posted | Number | percentage of participants | Baseline, Week 8, Week 52 |
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| 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. | ITT population included all enrolled participants who received at least one application of VOLUMA™. | Posted | Number | percentage of participants | Baseline, Week 8, Week 78 |
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| 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. | ITT population included all enrolled participants who received at least one application of VOLUMA™. | Posted | Number | percentage of participants | Baseline, Week 8, Week 104 |
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| 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. | Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis. | Posted | Number | percentage of participants | Baseline, Weeks 4, 8, 52, 78 and 104 |
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| 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. | Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 4, 8, 52, 78 and 104 |
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| 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. | Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 4, 8, 52, 78 and 104 |
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| 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. | Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Weeks 4, 8, 52, 78 and 104 |
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| 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. | Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis. | Posted | Mean | Standard Deviation | years | Baseline, Weeks 4, 8, 52, 78 and 104 |
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| 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. | Participants from the ITT population, all enrolled participants who received at least one application of VOLUMA™, with data available for analysis. | Posted | Number | percentage of participants | Week 8 |
|
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|
| 0 |
| 103 |
| 65 |
| 103 |
| EG001 | Juvederm® VOLUMA™_Phase 2 | 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. | 1 | 99 | 8 | 99 |
| Pain of skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Swelling face | Skin and subcutaneous tissue disorders | Systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to release and can embargo communications regarding trial results for a period that is less than or equal to 120 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Measurements |
|---|---|
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| Left Side Week 78 (n=82) |
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| Left Side Week 104 (n=72) |
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| Right Side Week 4 (n=103) |
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| Right Side Week 8 (n=99) |
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| Right Side Week 52 (n=68) |
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| Right Side Week 78 (n=82) |
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| Right Side Week 104 (n=72) |
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| Title | Measurements |
|---|---|
|
| Change from Baseline at Week 52 (n=68) |
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| Change from Baseline at Week 78 (n=82) |
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| Change from Baseline at Week 104 (n=72) |
|
| Title | Measurements |
|---|---|
|
| Week 78 (n=82) |
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| Week 104 (n=72) |
|
| Title | Measurements |
|---|---|
|
| Week 78 (n=82) |
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| Week 104 (n=72) |
|
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| Change from Baseline at Week 78 (n=82) |
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| Change from Baseline at Week 104 (n=72) |
|