To Evaluate the Performance and Safety of YVOIRE Volume Plus for Improvement of Mid-face Volume

A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate Performance and Safety of YVOIRE Volume Plus Versus Restylane Lyft with Lidocaine for Temporary Improvement of Mid-face Volume

A Study to Evaluate the Performance and Safety of YVOIRE volume plus for Temporary Improvement of Mid-face Volume

Study Overview

• Status: Completed
• Conditions: Midface Volume Deficit
• Intervention / Treatment: Device: YVOIRE volume plus; Device: Restylane Lyft with Lidocaine

Detailed Description

This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate the Performance and Safety of YVOIRE volume plus versus Restylane Lyft with Lidocaine for Temporary Improvement of Mid-face Volume.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany
    • LG Chem investigational site 01

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male and female aged between 21 to 75 years (inclusive)
• 2 or 3 on the 5-point MFVLRS (Mid Face Volume Loss Rating Scale)
• Desire cheek augmentation to correct volume deficit in the midface.
• Agree to use contraception
• Sign Informed Consent Form

Exclusion Criteria:

• have undergone facial plastic surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers in the midface area
• have undergone temporary facial dermal filler injections with HA-based fillers within 12 months, porcine-based collagen fillers within 24 months prior to screening
• have mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
• have history of anaphylaxis, multiple severe allergies, or allergy to lidocaine, HA products, or Streptococcal protein
• have history of bleeding disorder
• have a tendency to develop hypertrophic scarring or keloid

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 volume plus; Hyaluronic acid dermal filler	Device: YVOIRE volume plus; Hyaluronic acid dermal filler
Active Comparator: Restylane Lyft with Lidocaine; Hyaluronic acid dermal filler	Device: Restylane Lyft with Lidocaine; Hyaluronic acid dermal filler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-inferiority of YVOIRE volume plus versus Restylane Lyft with Lidocaine	To demonstrate non-inferiority of YVOIRE volume plus versus Restylane Lyft with Lidocaine in the improvement of mid face volume by comparing the mean change from Baseline in the Mid Face Volume Loss Rating Scale (MFVLRS) at 24 weeks after the final treatment	24 weeks from baseline
Responder rate of YVOIRE volume plus	To confirm performance of YVOIRE volume plus by the responder rate (defined as at least 1-point improvement from Baseline) at 24 weeks after the final treatment	24 weeks from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change of Mid Face Volume Loss Rating Scale (MFVLRS)	To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the MFVLRS	4, 8, 12, 52 weeks from baseline
Responder rate of YVOIRE volume plus	To confirm performance of YVOIRE volume plus by the responder rate (defined as at least 1-point improvement from Baseline) at 24 weeks after the final treatment	4, 8, 12, 52 weeks from baseline
Mean Score of Mid Face Volume Loss Rating Scale (MFVLRS)	o compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the MFVLRS	4, 8, 12, 24, 52 weeks from baseline
The mean scores of the GAIS	To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on Global Aesthetic Improvement Scale (GAIS)	4, 8, 12, 24, 52 weeks from baseline
Mean change in mid-face volume	To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the three dimensional (3-D) photograph measurement	24 weeks from baseline

Collaborators and Investigators

• Sponsor: LG Chem
• Investigators: Principal Investigator: Investigator, LG Chem investigational site 01

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2021
• Primary Completion (Actual): April 11, 2022
• Study Completion (Actual): October 26, 2022

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Lidocaine
• Other Study ID Numbers: LG-HACL029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No