Neuramis® Volume Lidocaine for Volume Augmentation in the Mid-Face

Study Overview
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Brief Summary
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To evaluate the effectiveness and safety of Neuramis® Volume Lidocaine for volume augmentation in the mid-face.

Detailed Description
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This is a multicenter, randomized, evaluator-blinded, no-treatment controlled study conducted in normal, healthy subjects. This study is anticipated to enroll approximately 236 male and/or female subjects between the ages of 20 to 75 years, inclusive, who desire volume augmentation to correct deficit in their mid-face volume.

Official Title
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A Multicenter Randomized, Evaluator-Blinded, No Treatment Controlled Study to Evaluate the Effectiveness and Safety of Neuramis® Volume Lidocaine for Volume Augmentation in the Mid-Face

Conditions
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Mid Face Volume Loss

Intervention / Treatment
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* Device: experimental
* Drug: comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 20 to 75 years of age Subjects who desire volume augmentation to correct deficit in the mid-face volume that is rated as Grade 3, 4, or 5 on the Facial Volume Scale Exclusion Criteria: Subjects who have received anti coagulation, anti-platelet, or thrombolytic medications, anti-inflammatory drugs. Subjects who have undergone facial plastic surgery in the face area below the level of the lower orbital rim, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or are planning to undergo any of these procedures at any time during the clinical investigation.

Ages Eligible for Study
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Minimum Age: 20 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: Investigational medical device<br>Neuramis® Volume Lidocaine | Device: experimental<br>* Neuramis® Deep Lidocaine<br>|
| Other: Comparator device<br>No-treatment | Drug: comparator<br>* No-treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Facial Volume Scale(FVS) improvement rate at Week 24 | Facial Volume Scale score ranges from 0-5 with higher score indicating increasing severity of mid-face volume deficit / Proportion of subjects with Facial Volume Scale(FVS) showing ≥1-point improvement (Facial Volume Scale decrease ≥1) at Week 24 compared to Baseline | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-point Facial Volume Scale(FVS) improvement rate at Weeks 4, 12, 36, and 52 | The proportion of subjects with 6-point Facial Volume Scale(FVS) decrease ≥1 from Baseline as assessed at Weeks 4, 12, 36, and 52. | Weeks 4, 12, 36, and 52 | 
| Change in 6-point Facial Volume Scale(FVS) at Weeks 4, 12, 24, 36, and 52 | Change in 6-point Facial Volume Scale(FVS) at Weeks 4, 12, 24, 36, and 52 | Weeks 4, 12, 24, 36, and 52 | 
| Global Aesthetic Improvement Scale(GAIS) improvement rate at Weeks 4, 12, 24, 36, and 52 | Global Aesthetic Improvement Scale(GAIS) improvement rate is defined as the proportion of subjects with GAIS score ≤3 | Weeks 4, 12, 24, 36, and 52 |