Dorsal Hand Volume Loss
Conditions
Keywords
Hyalunic acid, Filler, Dorsal hand, Medical device
Brief summary
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.
Interventions
DEVICEYVOIRE Y-Solution 360
Hyaluronic acid
Sponsors
LG Chem
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. 19 Years and older 2. Hand Volume Rating Scale (HVRS) of grade 2 or 3 with both hands 3. Participants who are willing to undergo the treatment of dorsal hand to correct volume loss
Exclusion criteria
1. Congenital defect, external injuries, lipodystrophy, unhealed wound, disease related-abnormalities, or tumors on the dorsal hands 2. Active inflammation or infection on the dorsal hands 3. Received anti-coagulation therapy, anti-platelet therapy, or expected to require repeated treatment within 2 weeks prior to visit 2 (randomization) 4. Had locally applied ointments (steroid, retinoid, anti-wrinkle production, tanning, or any other form of irritating product) or expected to require repeated treatment within 4 weeks prior to visit 2 (randomization) 5. Received immuno-suppressive medication including systemic glucocorticoids or expected to require repeated treatment within 8 weeks prior to visit 2 (randomization) 6. Received NSAIDs, Vitamin E, or expected to require repeated treatment within 1 week prior to visit 2 (randomization) 7. Had dermal filler injections (HA, CaHA, silicon, PAAG, PMMA etc.), Botulinum toxin therapy, adipose tissue transplantation, or esthetic surgery within 12 months prior to visit 2 (randomization)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ≥ 1 grade improvement on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded | 12 weeks after treatment | 5-grade photonumeric hand grading scale (grade 0 - grade 4) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ≥ 1 grade improvement on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded and the treating investigator | Up to 52 weeks after treatment | 5-grade photonumeric hand grading scale (grade 0 - grade 4) |
| ≥ 1 grade improvement on Global Aesthetic Improvement Scale (GAIS) as assessed by the treating investigator and the subject | Up to 52 weeks after treatment | 5-point scale rating global aesthetic improvement in appearance (score -1 - score 3) |
| Change from baseline on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded and the treating investigator | Up to 52 weeks after treatment | 5-grade photonumeric hand grading scale (grade 0 - grade 4) |
| Change from baseline on Global Aesthetic Improvement Scale (GAIS) as assessed by the treating investigator and the subject | Up to 52 weeks after treatment | 5-point scale rating global aesthetic improvement in appearance (score -1 - score 3) |
| Safety profile as assessed by incidence of adverse events | Up to 52 weeks after treatment | — |
Countries
South Korea
Outcome results
None listed