Volume Defects in the Mid-face
Conditions
Brief summary
To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face
Interventions
DEVICEYVOIRE Y-Solution 720
Hyaluronic acid dermal filler
Sponsors
LG Chem
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female adults 18 to 65 years of age (inclusive) * 3 (moderate) or 4 (severe) on MFVDA-SRS * sign the written informed consent form
Exclusion criteria
* have streptococcal disease or bleeding disorder * have an active or infective skin disease, scars, or tumor on mid-face * have congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases * have undergone facial plastic surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent procedures/treatment * have undergone temporary facial dermal filler within 12 months, porcine-based collagen fillers within 24 months, or neuromodulator injections, mesotherapy, or resurfacing within 6 months * have a medical history of hypertrophic cicatrix or keloid * have radiation therapy experience on mid-face * have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine, hyaluronic acid products, or Streptococcal protein
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asian Faces Mid-Face Volume Deficit Severity Rating Scale (MFVDA-SRS) responder rate | 26 weeks from baseline | the proportion of subjects with ≥1-grade reduction on the MFVDA-SRS score (The MFVDA-SRS score ranges from 1-4 with higher score indicating increasing severity of mid-face volume deficit.) |
Countries
China
Outcome results
None listed