Status:
TERMINATED
A Study of YVOIRE Y-Solution 360 for Hand Augmentation to Correct Volume Loss
Lead Sponsor:
LG Chem
Conditions:
Dorsal Hand Volume Loss
Eligibility:
All Genders
19+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 19 Years and older
- Hand Volume Rating Scale (HVRS) of grade 2 or 3 with both hands
- Participants who are willing to undergo the treatment of dorsal hand to correct volume loss
Exclusion
- Congenital defect, external injuries, lipodystrophy, unhealed wound, disease related-abnormalities, or tumors on the dorsal hands
- Active inflammation or infection on the dorsal hands
- Received anti-coagulation therapy, anti-platelet therapy, or expected to require repeated treatment within 2 weeks prior to visit 2 (randomization)
- 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)
- Received immuno-suppressive medication including systemic glucocorticoids or expected to require repeated treatment within 8 weeks prior to visit 2 (randomization)
- Received NSAIDs, Vitamin E, or expected to require repeated treatment within 1 week prior to visit 2 (randomization)
- 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)
Key Trial Info
Start Date :
September 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2020
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT04112017
Start Date
September 27 2019
End Date
October 14 2020
Last Update
January 22 2021
Active Locations (2)
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1
Soonchunhyang University
Bucheon-si, Gyeonggi-do, South Korea
2
Eulji Hospital
Seoul, South Korea