A Study of YVOIRE Y-Solution 360 for Hand Augmentation to Correct Volume Loss

NCT04112017 | Terminated

• 1 other identifier: LG-HACL019
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 2

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.

Conditions

Dorsal Hand Volume Loss

Keywords

Hyalunic acid; Filler; Dorsal hand; Medical device

Outcome Measures

Primary Outcomes (1)

• ≥ 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)

  12 weeks after treatment

Secondary Outcomes (5)

• ≥ 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

• ≥ 1 grade improvement on Global Aesthetic Improvement Scale (GAIS) as assessed by the treating investigator and the subject

  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

  Up to 52 weeks after treatment

• Change from baseline on Global Aesthetic Improvement Scale (GAIS) as assessed by the treating investigator and the subject

  Up to 52 weeks after treatment

• Safety profile as assessed by incidence of adverse events

  Up to 52 weeks after treatment

Study Arms (2)

YVOIRE Y-Solution 360

EXPERIMENTAL

Maximum 5 ml including touch-up

Device: YVOIRE Y-Solution 360

No-treatment

NO INTERVENTION

No-treatment. At 12 weeks after the assessment, treatment maximum 5 ml including touch-up

Interventions

YVOIRE Y-Solution 360 DEVICE

Hyaluronic acid

YVOIRE Y-Solution 360

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• LG Chem: lead

Study Sites (2)

Soonchunhyang University

Bucheon-si, Gyeonggi-do, South Korea

Location

Eulji Hospital

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 2, 2019
• Study Start: September 27, 2019
• Primary Completion: October 14, 2020
• Study Completion: October 14, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

KR (2)