Clinical Study to Evaluate the Efficacy and Safety of YVOIRE® Contour Compared With Restylane SubQ™ Injected Into the Anteromedial Malar Region

Study Overview
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Brief Summary
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This study is purposed to evaluate the efficacy and safety of YVOIRE® contour compared with Restylane SubQ™ injected into the anteromedial malar region.

Conditions
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Normal, Healthy Adults With Moderate, Severe, or Very Severe Volume Loss of Anteromedial Malar Region

Intervention / Treatment
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* Device: YVOIRE® contour
* Device: Restylane SubQ™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be male or female, 20-65 years of age Have anteromedial malar region volume loss as grade 2, 3, or 4 on the Mid Face Aesthetic Scale (MFAS) symmetrically on both sides Desire filler treatment to correct volume loss in the anteromedial malar region Accept the obligation not to receive any other mid facial procedures or treatments during the study Signed informed consent Those who fall under one of the following 3 cases Males or females who are surgically sterile Post-menopausal females who are above 45 years of age and 2 years after the last menstruation Fertile premenopausal females or males without having a surgical sterilization, who have agreed to use at least two contraception methods (one of the barrier methods must be included) for up to 14 days after the last treatment of the investigational device to avoid pregnancy Exclusion Criteria: Have a history of hypertrophic scars or keloids Other criteria as identified in the protocol

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: YVOIRE® contour<br> | Device: YVOIRE® contour<br>* YVOIRE® contour injection into the anteromedial malar region<br>|
| Active Comparator: Restylane SubQ™<br> | Device: Restylane SubQ™<br>* Restylane SubQ™ injection into the anteromedial malar region<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mid Face Aesthetic Scale (MFAS) score | Mean of MFAS score as assessed by the independent blinded rater | 26 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mid Face Aesthetic Scale (MFAS) score | Mean of MFAS score as assessed by the independent blinded rater | 2, 14, and 52 weeks after treatment | 
| Mid Face Aesthetic Scale (MFAS) score | Changes of MFAS score as assessed by the independent blinded rater | 2, 14, 26, and 52 weeks after treatment | 
| Mid Face Aesthetic Scale (MFAS) Responder rate | MFAS Responder (at least a one-point improvement on the MFAS) rate as assessed by the independent blinded rater | 2, 14, 26, and 52 weeks after treatment | 
| Global Aesthetic Improvement Scale (GAIS) score | Mean of GAIS score as assessed by subject | 2, 14, 26, and 52 weeks after treatment | 
| Global Aesthetic Improvement Scale (GAIS) Responder rate | GAIS Responder (at least a one-point improvement on the GAIS) rate as assessed by subject | 2, 14, 26, and 52 weeks after treatment |