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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational medical device | Experimental | Neuramis® Volume Lidocaine |
|
| Comparator medical device | Active Comparator | Juvederm® Voluma® with Lidocaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuramis® Volume Lidocaine | Device | hyaluronic acid filler |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
<Extension Study>
Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| BeomJoon Kim | Chung-Ang Univ. Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ang Univ. Medical Center | Seoul | Dongjak-gu | 156-755 | South Korea |
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| Juvederm® Voluma® with Lidocaine |
| Device |
hyaluronic acid filler |
|