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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
72
Hyaluronic acid dermal filler
LG Chem investigational site 01
Vienna, Austria
LG Chem investigational site 02
Vienna, Austria
LG Chem investigational site 03
Krakow, Poland
The primary effectiveness endpoint is the Jawline Contour Rating Scale (JCRS) responder rate at 26 weeks after the last injection
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).
Time frame: 26 weeks from baseline
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