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

Study Overview
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Brief Summary
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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.

Conditions
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Mid-face Volume Deficiency

Intervention / Treatment
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* Device: Cross-linked hyaluronic acid gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Juvederm® VOLUMA™<br>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<br>* Cross-linked hyaluronic acid gel (Juvederm® VOLUMA™) up to 4 mLs injected in each side of the face.<br>* Other names: Juvederm® VOLUMA™;|

What is the study measuring?
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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 | 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. | 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 | 

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) | 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 | 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 |