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

Not Applicable

Completed

• Conditions: Midface Volume Deficit
• Interventions: Device: Restylane Lyft with Lidocaine; Device: YVOIRE volume plus

• Registration Number: NCT04784299
• Lead Sponsor: LG Chem

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-03
• Study First Posted: 2021-03-05
• Study Start: 2021-03-22
• Primary Completion: 2022-04-11
• Study Completion: 2022-10-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restylane Lyft with Lidocaine	Restylane Lyft with Lidocaine	Hyaluronic acid dermal filler
YVOIRE volume plus	YVOIRE volume plus	Hyaluronic acid dermal filler

Primary Outcome Measures

Name	Time	Method
Responder rate of YVOIRE volume plus	24 weeks from baseline	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
Non-inferiority of YVOIRE volume plus versus Restylane Lyft with Lidocaine	24 weeks from baseline	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

Secondary Outcome Measures

Name	Time	Method
Mean Score of Mid Face Volume Loss Rating Scale (MFVLRS)	4, 8, 12, 24, 52 weeks from baseline	o compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the MFVLRS
The mean scores of the GAIS	4, 8, 12, 24, 52 weeks from baseline	To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on Global Aesthetic Improvement Scale (GAIS)
Mean Change of Mid Face Volume Loss Rating Scale (MFVLRS)	4, 8, 12, 52 weeks from baseline	To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the MFVLRS
Responder rate of YVOIRE volume plus	4, 8, 12, 52 weeks from baseline	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
Mean change in mid-face volume	24 weeks from baseline	To compare the performance of YVOIRE volume plus to Restylane Lyft with Lidocaine based on the three dimensional (3-D) photograph measurement

Trial Locations

Locations (1)

LG Chem investigational site 01; 🇩🇪 Munich, Germany