Effectiveness and Safety of YVOIRE Y-Solution 540

LG Chem394 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

394

Conditions

Wrinkles in the Nasolabial Folds

Interventions

YVOIRE Y-Solution 540DEVICE

Injection into the deep dermis layer and/or subcutaneous layer in the nasolabial folds based on the randomization assignment.

YVOIRE volume plusDEVICE

Injection into the deep dermis layer and/or subcutaneous layer in the nasolabial folds based on the randomization assignment.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Outcomes

Primary Outcomes

WSRS responder rate

the proportion of subjects with ≥ 1 grade improvement on the wrinkle severity rating scale (WSRS) score

Time frame: 24 weeks after the last injection

Data from ClinicalTrials.gov

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