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CompletedNCT04437745Updated Feb 9, 2024

To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face

An interventional study of YVOIRE Y-Solution 720 in Volume Defects in the Mid-face, sponsored by LG Chem. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-09.

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

Phase
Not applicable
Study type
Interventional
Enrollment
238
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face

02

Conditions studied

  • Volume Defects in the Mid-face
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
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male or female adults 18 to 65 years of age (inclusive)
  • 3 (moderate) or 4 (severe) on MFVDA-SRS
  • sign the written informed consent form

Exclusion criteria

Exclusion Criteria:

  • have streptococcal disease or bleeding disorder
  • have an active or infective skin disease, scars, or tumor on mid-face
  • have congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
  • have undergone facial plastic surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent procedures/treatment
  • have undergone temporary facial dermal filler within 12 months, porcine-based collagen fillers within 24 months, or neuromodulator injections, mesotherapy, or resurfacing within 6 months
  • have a medical history of hypertrophic cicatrix or keloid
  • have radiation therapy experience on mid-face
  • have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine, hyaluronic acid products, or Streptococcal protein
05

Study design

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

Study arms

  • Experimental
    YVOIRE Y-Solution 720

    Hyaluronic acid dermal filler

    Device: YVOIRE Y-Solution 720

  • No intervention
    Control

    No Intervention

Interventions

  • DeviceYVOIRE Y-Solution 720

    Hyaluronic acid dermal filler

06

What researchers measure

Primary outcomes

  1. Asian Faces Mid-Face Volume Deficit Severity Rating Scale (MFVDA-SRS) responder rate

    the proportion of subjects with ≥1-grade reduction on the MFVDA-SRS score (The MFVDA-SRS score ranges from 1-4 with higher score indicating increasing severity of mid-face volume deficit.)

    Time frame: 26 weeks from baseline

07

Study locations

1 site
  • Peking Union Medical College Hospital
    Beijing, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04437745
Lead sponsor
LG Chem
Responsible party
Sponsor
First posted
Jun 18, 2020
Start date
Nov 25, 2020
Primary completion
Dec 13, 2022
Completion
Nov 8, 2023
Last update
Feb 9, 2024

Study contacts

Xiaojun Wang
principal investigator · Peking Union Medical College Hospital

Oversight

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

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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