Jaw Volume Deficit
Conditions
Brief summary
A Multicenter, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring
Detailed description
This is a Multicenter, Randomized, Evaluator-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected for Jawline Contouring.
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 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female adults 18 - 75 years of age (inclusive) * 2 (moderate) or 3 (severe) on Jawline Contour Rating Scale (JCRS) * want a filler injection procedure for the replacement of volume loss in the jawlines
Exclusion criteria
* have an active or infective skin disease * have lower-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases * have a tattoo or excessive facial hair in the evaluation area * have received permanent facial implants * have undergone semi-permanent filler within 24 months * have undergone temporary dermal filler treatment in the lower face (below the orbital rim) within 12 months * have streptococcal disease * have a medical history of hypertrophic cicatrix, hyperpigmentation or keloid * have a history of anaphylaxis, multiple severe allergies, or allergy to lidocaine (or any amide-based anesthetic), or hyaluronic acid products * have history of bleeding disorder * have severe cardiovascular, hepatic or renal diseases considered as per Investigator's discretion * have known malignant tumors or cancerous or precancerous lesion * positive pregnancy test indicating pregnancy * active COVID-19 infection and suspected COVID-19 infection within the past 14 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary effectiveness endpoint is the Jawline Contour Rating Scale (JCRS) responder rate at 26 weeks after the last injection | 26 weeks from baseline | The primary effectiveness endpoint is the Jawline Contour Rating Scale (JCRS) responder rate at 26 weeks after the last injection for the test group and at Week 26 for the control group, i.e., the proportion of subjects with ≥1 grade improvement on the JCRS score (both jawlines) rated by independent blinded Evaluators at the site (Evaluating Investigator) at Visit 5, compared to that at Baseline (Visit 1). |
Countries
Austria, Poland
Outcome results
None listed