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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Jaw Volume Deficit
- Sponsor
- LG Chem
- Enrollment
- 72
- Locations
- 3
- Primary Endpoint
- The primary effectiveness endpoint is the Jawline Contour Rating Scale (JCRS) responder rate at 26 weeks after the last injection
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
The primary effectiveness endpoint is the Jawline Contour Rating Scale (JCRS) responder rate at 26 weeks after the last injection
Time Frame: 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).