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

A Multicenter, Randomized, Rater-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face

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

Study Overview

• Status: Completed
• Conditions: Volume Defects in the Mid-face
• Intervention / Treatment: Device: YVOIRE Y-Solution 720

• Study Type: Interventional
• Enrollment (Actual): 238
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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:

• 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

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
No Intervention: Control; No Intervention
Experimental: YVOIRE Y-Solution 720; Hyaluronic acid dermal filler	Device: YVOIRE Y-Solution 720; Hyaluronic acid dermal filler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.)	26 weeks from baseline

Collaborators and Investigators

• Sponsor: LG Chem
• Investigators: Principal Investigator: Xiaojun Wang, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2020
• Primary Completion (Actual): December 13, 2022
• Study Completion (Actual): November 8, 2023

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (Actual): June 18, 2020

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: LG-HACL022

Drug and device information, study documents

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