Extension Clinical Study to Evaluate the Long-term Efficacy and Safety of Repeat Treatment of YVOIRE Contour Injected Into the Anteromedial Malar Region in Subjects Who Have Completed the LG-HACL014 Study

Study Overview
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Brief Summary
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This study is purposed to evaluate the long-term efficacy and safety of repeat treatment of YVOIRE contour injected into the anteromedial malar region in subjects who have completed the LG-HACL014 study.

Official Title
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A Multicenter, Extension Clinical Study to Evaluate the Long-term Efficacy and Safety of Repeat Treatment of YVOIRE Contour Injected Into the Anteromedial Malar Region in Subjects Who Have Completed the LG-HACL014 Study

Conditions
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Normal, Healthy Adults With Moderate, Severe, or Very Severe Volume Loss of Anteromedial Malar Region Who Have Completed the LG-HACL014 Study

Intervention / Treatment
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* Device: YVOIRE contour


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible subjects who have completed the LG-HACL014 study Have anteromedial malar region volume loss at least a one-point worse on the MFAS compared with 2 weeks after treatment in the LG-HACL014 study 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 repeat 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


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>|

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 | 2, 26, and 52 weeks after repeat treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mid Face Aesthetic Scale (MFAS) score | Changes of MFAS score as assessed by the independent blinded rater | 2, 26, and 52 weeks after repeat 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, 26, and 52 weeks after repeat treatment | 
| Global Aesthetic Improvement Scale (GAIS) score | Mean of GAIS score as assessed by subject | 2, 26, and 52 weeks after repeat 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, 26, and 52 weeks after repeat treatment |