Neuramis® Volume Lidocaine Treatment in Patients With Loss of Mid-face Volume

Study Overview
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Brief Summary
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The purpose of this study is to compare the safety and efficacy of Neuramis® Volume Lidocaine, which is a biomaterial prosthesis and graft, with Juvederm® Voluma® with Lidocaine, for the patients who need correction due to a moderate-to-severe volume loss in the mid-facial region by inducing temporary volume restoration in mid-facial region. After the pivotal study, extension study will be conducted to confirm long-term safety and efficacy.

Detailed Description
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This is a multi-centered, randomized, double-blind, split-face clinical study on investigational device. The subjects in this clinical trial receive application of the investigational device on the right and left side of the mid-facial region (Neuramis® Volume Lidocaine or Juvederm® Voluma® with Lidocaine). After the pivotal study, extension study will be conducted to confirm long-term safety and efficacy.

Official Title
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Clinical Study of Neuramis® Volume Lidocaine to Evaluate the Efficacy and Safety for Temporary Restoring the Mid-face Volume

Conditions
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Aging

Intervention / Treatment
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* Device: Neuramis® Volume Lidocaine
* Device: Juvederm® Voluma® with Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject aged between 35 and 65. Mid-facial region symmetrical, severity greater than MFVDS moderate-to-severe level Exclusion Criteria: Those who have anticoagulant therapy, antiplatelet therapy, and non-steroidal anti-inflammatory drugs Those who have history of receiving the procedures which are considered to affect on the assessment of this clinical trial. Those who has thin skin in the mid-facial area Those with hypersensitivity to sodium hyaluronate or lidocaine or amide type local anesthetics <Extension Study> Inclusion Criteria: Participated in the pivotal study and completed the end of study visit Agreed not to receive any procedure or treatment that may have an effect on the restoration of the mid-face volume while participating in the extension study Exclusion Criteria Those who have following procedual history between completion of the pivotal study and entry of extension study - facial plastic surgery, tissue grafting or tissue augmentation using implant, thread lifting Subjects with asymmetric MVD(Mid-face volume deficit) or facial scar interfering with accurate assessment

Ages Eligible for Study
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Minimum Age: 35 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational medical device<br>Neuramis® Volume Lidocaine | Device: Neuramis® Volume Lidocaine<br>* hyaluronic acid filler<br>|
| Active Comparator: Comparator medical device<br>Juvederm® Voluma® with Lidocaine | Device: Juvederm® Voluma® with Lidocaine<br>* hyaluronic acid filler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS) | MFVDS 0- None, 1-Minimal, 2-Mild, 3-Moderate, 4-Significant, 5-Severe The lower score, the better condition. | 24 weeks | 
| Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS) | Primary outcome for extension study | 104 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes in overall Mid-Face Volume Deficit Scale(MFVDS) at each visit |  | 104 weeks | 
| Ratio of subjects defined as improved by blinded investigators and the subjects according to the Global Aesthetic Improvement Scale (GAIS) |  | 104 weeks |