Effectiveness and Safety of YVOIRE Y-Solution 540

LG Chem

Status: Completed

Conditions: Wrinkles in the Nasolabial Folds

Treatments: Device: YVOIRE Y-Solution 540; Device: YVOIRE volume plus

Study type: Interventional

Funder types: Industry

Identifiers

NCT04855188

LG-HACL027

Details and patient eligibility

About

To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 540 versus YVOIRE volume plus in Nasolabial Folds Injection

Enrollment: 394 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 3 (moderate) or 4 (severe) on the 5-graded WSRS
• who sign the written informed consent form

Exclusion criteria

• who have received permanent facial implants
• who have received semi-permanent fillers
• who have undergone temporary dermal filler treatment within 12 months
• who have undergone facial tissue augmentation with fat injections, botulinum toxin injections, mesotherapy, or cosmetic procedures within 6 months
• who have a history of anaphylaxis or allergy to lidocaine, hyaluronic acid (HA) products, or streptococcal protein

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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394 participants in 2 patient groups

YVOIRE Y-Solution 540

Experimental group

Treatment:

Device: YVOIRE Y-Solution 540

YVOIRE volume plus

Active Comparator group

Treatment:

Device: YVOIRE volume plus