A Prospective, Multicenter, Randomized, Comparator-controlled, Evaluator-blinded Study to Evaluate the Safety and Effectiveness of VP1 Lido US for Volume Augmentation of the Cheek

Study Overview
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Brief Summary
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The primary objective of the study is to demonstrate non-inferiority of VP1 Lido US versus an approved hyaluronic acid dermal filler following deep (subdermal and/or supraperiosteal) injection of the cheek for volume augmentation.

Official Title
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A Prospective, Multicenter, Randomized, Comparator-controlled, Evaluator-blinded Study to Evaluate the Safety and Effectiveness of VP1 Lido US for Volume Augmentation of the Cheek

Conditions
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Cheek Volume Augmentation

Intervention / Treatment
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* Device: VP1 Lido US
* Device: Restylane Lyft Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has a symmetrical rating of 2 (moderate) or 3 (severe) for right and left cheek on the Merz Cheeks Fullness Assessment Scale (MCFAS) Desires cheek augmentation to correct volume deficit in the midface and is willing to receive sufficient volume to achieve at least a 1-point improvement on the MCFAS Exclusion Criteria: Skin or fat atrophy in the midfacial region other than that related to age. Subjects with body mass index of <18.5 or ≥30 Acute inflammatory process or active infection at the injection site (e.g., acne, eczema, streptococcus infections), or history of chronic or recurrent infection or inflammation with the potential to interfere with the study results or increase the risk of AEs. Prior surgery, including midfacial plastic surgery, or has a permanent implant or graft in the midfacial region that could interfere with effectiveness assessments. Received midfacial region treatments with porcine-based collagen fillers or with RADIESSE® or with volumizing hyaluronic acid fillers such as but not limited to Juvéderm® Voluma, Restylane® Lyft within the past 24 months and/or with other HA fillers or mesotherapy within the past 12 months or plans to receive such treatments during participation in the study. Received facial dermal therapies (i.e., facial ablative or fractional laser, dermabrasion, chemical peels, non-invasive skin-tightening [e.g., Ultherapy®, Thermage®] and surgical procedures) in the midfacial region within the past 12 months or plans to receive them in the facial region during participation in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VP1 Lido US - NC<br>Injection to the left cheek via needle and to the right cheek via canula | Device: VP1 Lido US<br>* Hyaluronic acid dermal filler containing lidocaine<br>|
| Experimental: VP1 Lido US - CN<br>Injection to the left cheek via canula and to the right cheek via needle | Device: VP1 Lido US<br>* Hyaluronic acid dermal filler containing lidocaine<br>|
| Active Comparator: Restylane Lyft Lidocaine - NC<br>Injection to the left cheek via needle and to the right cheek via canula | Device: Restylane Lyft Lidocaine<br>* Hyaluronic acid dermal filler containing lidocaine<br>|
| Active Comparator: Restylane Lyft Lidocaine - CN<br>Injection to the left cheek via canula and to the right cheek via needle | Device: Restylane Lyft Lidocaine<br>* Hyaluronic acid dermal filler containing lidocaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Week 12 on the Merz Cheeks Fullness Assessment Scale (MCFAS) | The MCFAS is a 5-point ordinal rating | Baseline to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Week 12 on the MCFAS by injection type (cannula, needle) |  | Baseline to week 12 | 
| Treatment response rate where response is defined as a ≥ 1-point improvement on both cheeks when comparing the change from baseline to Week 12 |  | Baseline to week 12 | 
| FACE-Q satisfaction with cheeks for treated subjects at baseline and Week 12 |  | Week 12 | 
| Global Aesthetic Improvement Scale (GAIS) scores for treated subjects at Week 12, as completed by the treating investigator |  | Week 12 | 
| GAIS scores for treated subjects at Week 12, as completed by the subject |  | Week 12 | 
| Responder rates at Week 12, according to the MCFAS, as assessed by three blinded board-certified Independent Panel Reviewers (IPRs) using subject photographs |  | Week 12 | 
| Incidence of related serious or delayed onset adverse events (>21 days after treatment) following the first treatment including touch-up until Week 48 |  | Baseline to week 48 |