Aging
Conditions
Brief summary
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
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.
Interventions
DEVICENeuramis® Volume Lidocaine
hyaluronic acid filler
hyaluronic acid filler
Sponsors
Medy-Tox
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subject aged between 35 and 65. 2. Mid-facial region symmetrical, severity greater than MFVDS moderate-to-severe level
Exclusion criteria
1. Those who have anticoagulant therapy, antiplatelet therapy, and non-steroidal anti-inflammatory drugs 2. Those who have history of receiving the procedures which are considered to affect on the assessment of this clinical trial. 3. Those who has thin skin in the mid-facial area 4. Those with hypersensitivity to sodium hyaluronate or lidocaine or amide type local anesthetics \<Extension Study\> Inclusion Criteria: 1. Participated in the pivotal study and completed the end of study visit 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS) | 24 weeks | MFVDS 0- None, 1-Minimal, 2-Mild, 3-Moderate, 4-Significant, 5-Severe The lower score, the better condition. |
Secondary
| Measure | 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 |
Countries
South Korea
Outcome results
None listed