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TerminatedNCT04112017Updated Jan 22, 2021

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

An interventional study of YVOIRE Y-Solution 360 in Dorsal Hand Volume Loss, sponsored by LG Chem. Terminated at 2 sites in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-22.

Sponsored by LG Chem · Not applicable, Interventional, and Treatment

Why this study was terminated
Sponsor's decision
Phase
Not applicable
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Dorsal Hand Volume Loss

Keywords

  • Hyalunic acid
  • Filler
  • Dorsal hand
  • Medical device
03

In context

Lead sponsor

LG Chem is the lead sponsor of 70 studies on the registry; 8 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 1 (8%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts 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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
116 participants (actual)

Study arms

  • Experimental
    YVOIRE Y-Solution 360

    Maximum 5 ml including touch-up

    Device: YVOIRE Y-Solution 360

  • No intervention
    No-treatment

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

Interventions

  • DeviceYVOIRE Y-Solution 360

    Hyaluronic acid

06

What researchers measure

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)

    Time frame: 12 weeks after treatment

Secondary outcomes

  1. ≥ 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)

    Time frame: Up to 52 weeks after treatment

  2. ≥ 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)

    Time frame: Up to 52 weeks after treatment

  3. 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)

    Time frame: Up to 52 weeks after treatment

  4. 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)

    Time frame: Up to 52 weeks after treatment

  5. Safety profile as assessed by incidence of adverse events

    Time frame: Up to 52 weeks after treatment

07

Study locations

2 sites
  • Soonchunhyang University
    Bucheon, Gyeonggi-do, Korea, Republic of
  • Eulji Hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04112017
Lead sponsor
LG Chem
Responsible party
Sponsor
First posted
Oct 2, 2019
Start date
Sep 27, 2019
Primary completion
Oct 14, 2020
Completion
Oct 14, 2020
Last update
Jan 22, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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