Normal, Healthy Adults With Moderate, Severe, or Very Severe Volume Loss of Anteromedial Malar Region
Conditions
Brief summary
This study is purposed to evaluate the efficacy and safety of YVOIRE® contour compared with Restylane SubQ™ injected into the anteromedial malar region.
Interventions
DEVICEYVOIRE® contour
YVOIRE® contour injection into the anteromedial malar region
DEVICERestylane SubQ™
Restylane SubQ™ injection into the anteromedial malar region
Sponsors
LG Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Be male or female, 20-65 years of age * Have anteromedial malar region volume loss as grade 2, 3, or 4 on the Mid Face Aesthetic Scale (MFAS) symmetrically on both sides * Desire filler treatment to correct volume loss in the anteromedial malar region * Accept the obligation not to receive any other mid facial procedures or treatments during the study * Signed informed consent * Those who fall under one of the following 3 cases 1. Males or females who are surgically sterile 2. Post-menopausal females who are above 45 years of age and 2 years after the last menstruation 3. Fertile premenopausal females or males without having a surgical sterilization, who have agreed to use at least two contraception methods (one of the barrier methods must be included) for up to 14 days after the last treatment of the investigational device to avoid pregnancy
Exclusion criteria
* Have a history of hypertrophic scars or keloids * Other criteria as identified in the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mid Face Aesthetic Scale (MFAS) score | 26 weeks after treatment | Mean of MFAS score as assessed by the independent blinded rater |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mid Face Aesthetic Scale (MFAS) score | 2, 14, and 52 weeks after treatment | Mean of MFAS score as assessed by the independent blinded rater |
| Mid Face Aesthetic Scale (MFAS) Responder rate | 2, 14, 26, and 52 weeks after treatment | MFAS Responder (at least a one-point improvement on the MFAS) rate as assessed by the independent blinded rater |
| Global Aesthetic Improvement Scale (GAIS) score | 2, 14, 26, and 52 weeks after treatment | Mean of GAIS score as assessed by subject |
| Global Aesthetic Improvement Scale (GAIS) Responder rate | 2, 14, 26, and 52 weeks after treatment | GAIS Responder (at least a one-point improvement on the GAIS) rate as assessed by subject |
Countries
South Korea
Outcome results
None listed