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

LG Chem

Status: Completed

Conditions: Volume Defects in the Mid-face

Treatments: Device: YVOIRE Y-Solution 720

Study type: Interventional

Funder types: Industry

Identifiers

NCT04437745

LG-HACL022

Details and patient eligibility

About

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

Enrollment: 238 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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238 participants in 2 patient groups

YVOIRE Y-Solution 720

Experimental group

Description:

Hyaluronic acid dermal filler

Treatment:

Device: YVOIRE Y-Solution 720

Control

No Intervention group

Description:

No Intervention