Midface Volume Deficit
Conditions
Brief summary
A Study to Evaluate the Performance and Safety of YVOIRE volume plus for Temporary Improvement of Mid-face Volume
Detailed description
This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate the Performance and Safety of YVOIRE volume plus versus Restylane Lyft with Lidocaine for Temporary Improvement of Mid-face Volume.
Interventions
DEVICEYVOIRE volume plus
Hyaluronic acid dermal filler
Hyaluronic acid dermal filler
Sponsors
LG Chem
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female aged between 21 to 75 years (inclusive) * 2 or 3 on the 5-point MFVLRS (Mid Face Volume Loss Rating Scale) * Desire cheek augmentation to correct volume deficit in the midface. * Agree to use contraception * Sign Informed Consent Form
Exclusion criteria
* have undergone facial plastic surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers in the midface area * have undergone temporary facial dermal filler injections with HA-based fillers within 12 months, porcine-based collagen fillers within 24 months prior to screening * have mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases * have history of anaphylaxis, multiple severe allergies, or allergy to lidocaine, HA products, or Streptococcal protein * have history of bleeding disorder * have a tendency to develop hypertrophic scarring or keloid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-inferiority of YVOIRE volume plus versus Restylane Lyft with Lidocaine | 24 weeks from baseline | To demonstrate non-inferiority of YVOIRE volume plus versus Restylane Lyft with Lidocaine in the improvement of mid face volume by comparing the mean change from Baseline in the Mid Face Volume Loss Rating Scale (MFVLRS) at 24 weeks after the final treatment |
| Responder rate of YVOIRE volume plus | 24 weeks from baseline | To confirm performance of YVOIRE volume plus by the responder rate (defined as at least 1-point improvement from Baseline) at 24 weeks after the final treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Score of Mid Face Volume Loss Rating Scale (MFVLRS) | 4, 8, 12, 24, 52 weeks from baseline | o compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the MFVLRS |
| Mean Change of Mid Face Volume Loss Rating Scale (MFVLRS) | 4, 8, 12, 52 weeks from baseline | To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the MFVLRS |
| Mean change in mid-face volume | 24 weeks from baseline | To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the three dimensional (3-D) photograph measurement |
| The mean scores of the GAIS | 4, 8, 12, 24, 52 weeks from baseline | To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on Global Aesthetic Improvement Scale (GAIS) |
| Responder rate of YVOIRE volume plus | 4, 8, 12, 52 weeks from baseline | To confirm performance of YVOIRE volume plus by the responder rate (defined as at least 1-point improvement from Baseline) at 24 weeks after the final treatment |
Countries
Germany
Outcome results
None listed