The purpose of this study is to evaluate the effectiveness and safety of YVOIRE Y-Solution 360 in the treatment of dorsal hand to correct volume loss.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
116
Hyaluronic acid
Soonchunhyang University
Bucheon-si, Gyeonggi-do, South Korea
Eulji Hospital
Seoul, South Korea
≥ 1 grade improvement on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded
5-grade photonumeric hand grading scale (grade 0 - grade 4)
Time frame: 12 weeks after treatment
≥ 1 grade improvement on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded and the treating investigator
5-grade photonumeric hand grading scale (grade 0 - grade 4)
Time frame: Up to 52 weeks after treatment
≥ 1 grade improvement on Global Aesthetic Improvement Scale (GAIS) as assessed by the treating investigator and the subject
5-point scale rating global aesthetic improvement in appearance (score -1 - score 3)
Time frame: Up to 52 weeks after treatment
Change from baseline on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded and the treating investigator
5-grade photonumeric hand grading scale (grade 0 - grade 4)
Time frame: Up to 52 weeks after treatment
Change from baseline on Global Aesthetic Improvement Scale (GAIS) as assessed by the treating investigator and the subject
5-point scale rating global aesthetic improvement in appearance (score -1 - score 3)
Time frame: Up to 52 weeks after treatment
Safety profile as assessed by incidence of adverse events
Time frame: Up to 52 weeks after treatment
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