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

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

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 Overview

• Status: Terminated
• Conditions: Dorsal Hand Volume Loss
• Intervention / Treatment: Device: YVOIRE Y-Solution 360

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Eulji Hospital
  • Gyeonggi-do
    • Bucheon, Gyeonggi-do, Korea, Republic of
      • Soonchunhyang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: YVOIRE Y-Solution 360; Maximum 5 ml including touch-up	Device: YVOIRE Y-Solution 360; Hyaluronic acid
No Intervention: No-treatment; No-treatment. At 12 weeks after the assessment, treatment maximum 5 ml including touch-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
≥ 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
≥ 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)	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)	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)	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)	Up to 52 weeks after treatment
Safety profile as assessed by incidence of adverse events		Up to 52 weeks after treatment

Collaborators and Investigators

• Sponsor: LG Chem

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2019
• Primary Completion (Actual): October 14, 2020
• Study Completion (Actual): October 14, 2020

Study Registration Dates

• First Submitted: September 27, 2019
• First Submitted That Met QC Criteria: September 29, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 20, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Medical device; Hyalunic acid; Filler; Dorsal hand
• Other Study ID Numbers: LG-HACL019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No