Mid Face Volume Loss
Conditions
Brief summary
To evaluate the effectiveness and safety of Neuramis® Volume Lidocaine for volume augmentation in the mid-face.
Detailed description
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.
Interventions
DEVICEexperimental
Neuramis® Deep Lidocaine
DRUGcomparator
No-treatment
Sponsors
Medy-Tox
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female 20 to 75 years of age 2. 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
1. Subjects who have received anti coagulation, anti-platelet, or thrombolytic medications, anti-inflammatory drugs. 2. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Facial Volume Scale(FVS) improvement rate at Week 24 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6-point Facial Volume Scale(FVS) improvement rate at Weeks 4, 12, 36, and 52 | 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. |
| Change in 6-point Facial Volume Scale(FVS) at Weeks 4, 12, 24, 36, and 52 | Weeks 4, 12, 24, 36, and 52 | Change in 6-point Facial Volume Scale(FVS) at Weeks 4, 12, 24, 36, and 52 |
| Global Aesthetic Improvement Scale(GAIS) improvement rate at Weeks 4, 12, 24, 36, and 52 | 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 |
Countries
China
Outcome results
None listed