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To evaluate the effectiveness and safety of Neuramis® Volume Lidocaine for volume augmentation in the mid-face.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational medical device | Experimental | Neuramis® Volume Lidocaine |
|
| Comparator device | Other | No-treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| experimental | Device | Neuramis® Deep Lidocaine |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hopsital | Beijing | China |
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| comparator |
| Drug |
No-treatment |
|
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 |