Clinical trial NCT04112017: A Study of YVOIRE Y-Solution 360 for Hand Augmentation to Correct Volume Loss
Official title: A Multicenter, Randomized, No-treatment Controlled, Parallel, Evaluator-blind, Medical Device Pivotal Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 360 Injected Into Dorsal Hand for Hand Augmentation to Correct Volume Loss
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dorsal Hand Volume Loss
Keywords: Hyalunic acid
Filler
Dorsal hand
Medical device
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2019-10-02
Enrollment: 116
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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)

Primary outcomes:
measure: ≥ 1 grade improvement on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded
timeFrame: 12 weeks after treatment
Secondary outcomes:
measure: ≥ 1 grade improvement on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded and the treating investigator
timeFrame: Up to 52 weeks after treatment
measure: ≥ 1 grade improvement on Global Aesthetic Improvement Scale (GAIS) as assessed by the treating investigator and the subject
timeFrame: Up to 52 weeks after treatment
measure: Change from baseline on Hand Volume Rating Scale (HVRS) as assessed by the evaluator-blinded and the treating investigator
timeFrame: Up to 52 weeks after treatment
measure: Change from baseline on Global Aesthetic Improvement Scale (GAIS) as assessed by the treating investigator and the subject
timeFrame: Up to 52 weeks after treatment
measure: Safety profile as assessed by incidence of adverse events
timeFrame: Up to 52 weeks after treatment
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Eulji Hospital
Study officials:
References: