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

LG Chem

Status

Completed

Conditions

Midface Volume Deficit

Treatments

Device: Restylane Lyft with Lidocaine

Device: YVOIRE volume plus

Study type

Interventional

Funder types

Industry

Identifiers

NCT04784299

LG-HACL029

Details and patient eligibility

About

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

Full 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.

Enrollment

105 patients

Sex

All

Ages

21 to 75 years old

Volunteers

Accepts Healthy Volunteers

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