A Clinical Study to Evaluate the Efficacy and Safety of YVOIRE Volume Plus Versus YVOIRE Volume in Nasolabial Fold Injection

Inclusion criteria

• Women aged between 30 and 60
• Those whose wrinkles in the treatment area (nasolabial fold) correspond to Stage 3 or 4 in the 5-stage Wrinkle Severity Rating Scale (WSRS) symmetrically
• Those who were informed on the purpose, method, and effect etc. of this study and signed the informed consent form
• Those who fell under any of the following 3 cases:

• Surgically sterile women
• Women in menopause over 2 years from the last menstruation, aged at least 45
• Among the women meeting neither of a nor b, those who agreed to use at least 2 contraception methods specified below (one of the barrier methods must be included) until 14 days after the last treatment with the investigational device

• Barrier methods: Condom, diaphragm, cervical cap (pessary), spermicide
• Hormonal methods: Pills, injection (depot), skin patch, hormonal implant (Implanon), vaginal ring
• Intrauterine devices (IUDs): Cooper IUD (Loop), hormonal IUD (Mirena)
• Natural methods: Basic body temperature, ovulation period, coitus interruptus, abstinent

Exclusion criteria

• Those with a skin disease (skin infection, eczema, psoriasis, rosacea, herpes etc.) in the lower 2/3 part of the face in which the wrinkle evaluation may be affected
• Patients with a malignant tumor recognized medically important and considered as potentially affecting the clinical study
• Women in pregnancy or lactation
• Those with the bilirubin level exceeding 1.5 times of the upper limit of normal or the ALT/AST level exceeding 2.5 times of the upper limit of normal
• Those with the confirmed infection of syphilis or HIV
• Those who had an anticoagulant therapy or antiplatelet therapy within 2 weeks prior to Visit 1 (screening)
• Those who used a topical preparation (steroid, retinoid) in the facial area within 4 weeks prior to Visit 2 (randomization )
• Those who experienced a deep chemical peeling or a procedure judged as potentially affecting the clinical study within 3 months prior to Visit 2 (randomization)
• Those who experienced a non-permanent filler procedure or a cosmetic surgery in the face within 9 months prior to Visit 2 (randomization)
• Those who had an implantation procedure with a permanent substance (silicone, PAAG, PMMA, CaHA etc.) in the treatment area (nasolabial fold )
• Those currently with a streptococcal disease
• Those with a history of severe allergy or hypersensitivity (anaphylaxis) judged as potentially affecting the clinical study
• Those with a history of hypertrophic scar or keloid
• Those with a history of bleeding disorder
• Those with a hypersensitivity to the investigational device of this clinical study or lidocaine
• Those who refused to agree not to use a local or systemic pain-relieving agent or other pain-relieving method (e.g.: ice pack) from the midnight of the treatment day with the investigational device through the post-measurement of the last VAS pain scale
• Those who had participated in another clinical study within 1 month prior to Visit 1 (screening)
• Those judged by the investigator as ineligible for this clinical study