Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring

Study Overview
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Brief Summary
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A Multicenter, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring

Detailed Description
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This is a Multicenter, Randomized, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring.

Official Title
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A Multicenter, Randomized, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring

Conditions
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Jaw Volume Deficit

Intervention / Treatment
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* Device: YVOIRE Y-Solution 720


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female adults 18 - 75 years of age (inclusive) 2 (moderate) or 3 (severe) on Jawline Contour Rating Scale (JCRS) want a filler injection procedure for the replacement of volume loss in the jawlines Exclusion Criteria: have an active or infective skin disease have lower-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases have a tattoo or excessive facial hair in the evaluation area have received permanent facial implants have undergone semi-permanent filler within 24 months have undergone temporary dermal filler treatment in the lower face (below the orbital rim) within 12 months have streptococcal disease have a medical history of hypertrophic cicatrix, hyperpigmentation or keloid have a history of anaphylaxis, multiple severe allergies, or allergy to lidocaine (or any amide-based anesthetic), or hyaluronic acid products have history of bleeding disorder have severe cardiovascular, hepatic or renal diseases considered as per Investigator's discretion have known malignant tumors or cancerous or precancerous lesion positive pregnancy test indicating pregnancy active COVID-19 infection and suspected COVID-19 infection within the past 14 days

Ages Eligible for Study
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Minimum Age: 18 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: Test group<br>Hyaluronic acid dermal filler at Week 0 | Device: YVOIRE Y-Solution 720<br>* Hyaluronic acid dermal filler<br>|
| No Intervention: Control group<br>Remain untreated until Week 26 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary effectiveness endpoint is the Jawline Contour Rating Scale (JCRS) responder rate at 26 weeks after the last injection | The primary effectiveness endpoint is the Jawline Contour Rating Scale (JCRS) responder rate at 26 weeks after the last injection for the test group and at Week 26 for the control group, i.e., the proportion of subjects with ≥1 grade improvement on the JCRS score (both jawlines) rated by independent blinded Evaluators at the site (Evaluating Investigator) at Visit 5, compared to that at Baseline (Visit 1). | 26 weeks from baseline |