To Evaluate the Performance and Safety of YVOIRE Volume Plus for Improvement of Mid-face Volume

Study Overview
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Brief Summary
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A Study to Evaluate the Performance and Safety of YVOIRE volume plus for Temporary Improvement of Mid-face Volume

Detailed Description
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This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate the Performance and Safety of YVOIRE volume plus versus Restylane Lyft with Lidocaine for Temporary Improvement of Mid-face Volume.

Official Title
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A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate Performance and Safety of YVOIRE Volume Plus Versus Restylane Lyft With Lidocaine for Temporary Improvement of Mid-face Volume

Conditions
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Midface Volume Deficit

Intervention / Treatment
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* Device: YVOIRE volume plus
* Device: Restylane Lyft with Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female aged between 21 to 75 years (inclusive) 2 or 3 on the 5-point MFVLRS (Mid Face Volume Loss Rating Scale) Desire cheek augmentation to correct volume deficit in the midface. Agree to use contraception Sign Informed Consent Form Exclusion Criteria: have undergone facial plastic surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers in the midface area have undergone temporary facial dermal filler injections with HA-based fillers within 12 months, porcine-based collagen fillers within 24 months prior to screening have mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases have history of anaphylaxis, multiple severe allergies, or allergy to lidocaine, HA products, or Streptococcal protein have history of bleeding disorder have a tendency to develop hypertrophic scarring or keloid

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 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 volume plus<br>Hyaluronic acid dermal filler | Device: YVOIRE volume plus<br>* Hyaluronic acid dermal filler<br>|
| Active Comparator: Restylane Lyft with Lidocaine<br>Hyaluronic acid dermal filler | Device: Restylane Lyft with Lidocaine<br>* Hyaluronic acid dermal filler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-inferiority of YVOIRE volume plus versus Restylane Lyft with Lidocaine | To demonstrate non-inferiority of YVOIRE volume plus versus Restylane Lyft with Lidocaine in the improvement of mid face volume by comparing the mean change from Baseline in the Mid Face Volume Loss Rating Scale (MFVLRS) at 24 weeks after the final treatment | 24 weeks from baseline | 
| Responder rate of YVOIRE volume plus | To confirm performance of YVOIRE volume plus by the responder rate (defined as at least 1-point improvement from Baseline) at 24 weeks after the final treatment | 24 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change of Mid Face Volume Loss Rating Scale (MFVLRS) | To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the MFVLRS | 4, 8, 12, 52 weeks from baseline | 
| Responder rate of YVOIRE volume plus | To confirm performance of YVOIRE volume plus by the responder rate (defined as at least 1-point improvement from Baseline) at 24 weeks after the final treatment | 4, 8, 12, 52 weeks from baseline | 
| Mean Score of Mid Face Volume Loss Rating Scale (MFVLRS) | o compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the MFVLRS | 4, 8, 12, 24, 52 weeks from baseline | 
| The mean scores of the GAIS | To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on Global Aesthetic Improvement Scale (GAIS) | 4, 8, 12, 24, 52 weeks from baseline | 
| Mean change in mid-face volume | To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the three dimensional (3-D) photograph measurement | 24 weeks from baseline |