Medical Device Pivotal Study to Injection With SkinPlus-HYAL Implant Lidocaine vs RESTYLANE Lidocaine in of Nasolabial Folds

Medical Device Pivotal Study to Evaluate the Efficacy and Safety of Injection With SkinPlus-HYAL Implant Lidocaine as Compared to RESTYLANE Lidocaine in Temporary Correction of Nasolabial Folds

Purpose : This investigation intends to demonstrate that the investigational device, SkinPlus-HYAL Implant Lidocaine, is non-inferior to the comparator device, RESTYLANE Lidocaine, in terms of temporary wrinkle reduction effect, safety, and injection site pain when applied on nasolabial folds in adults.

Design : 24-week efficacy and safety evaluation and additional 48-week long-term safety and efficacy evaluation with a multi-center, randomized, subject- & evaluator-blind, matched pairs, active controlled, none-inferiority, confirmatory design

Treatment Group: Application of the investigational medical device (SkinPlus-HYAL Implant Lidocaine) Control Group: Application of the comparator device (RESTYLANE Lidocaine)

Population: Number of subject 100

* In this investigation, the same subject receives both test and control treatments, one on each side of the nasolabial folds (matched pairs design).

Inclusion Criteria:

• Men and women 19 years of age or older
• Seeking temporary improvement of bilateral nasolabial folds, with a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 (does not have to be the same on both sides)
• Agrees to discontinue all dermatologic procedures or treatments (fillers, botulinum toxin, laser treatments, chemical peels, surgery for cosmetic purposes, etc.) other than investigational device application, including facial wrinkle improvement
• Able to understand and follow instructions and able to participate in all periods of the investigation
• Made a voluntary decision to participate in this investigation and gave written informed consent

Exclusion Criteria:

• Took antithrombotic agents (except low-dose aspirin (100 mg, maximum 300 mg/day)) from 2 weeks before to 2 weeks after application of the investigational device; took vitamin E formulations or NSAID formulations from 1 week before to 1 week after application
• History of bleeding disorder in the past or at the time of screening
• CaHA (Calcium Hydroxyapatite) or PLLA (Poly L-Lactide) filler treatment at the site of application of the investigational medical device within 1 year before the screening date
• Has used or intends to use topical agents (steroids, retinoids: medicines only, excluding cosmetics) on the facial area within 4 weeks before the screening date or during the clinical trial period (however steroid ointments for therapeutic purposes may be used for a short period of time within 14 consecutive days).
• Used immunosuppressants, chemotherapeutic agents, or systemic corticosteroids within 12 weeks before the screening date.
• Received any anti-wrinkle or acne scar treatment within 24 weeks before the screening date.
• Received dermabrasion, skin resurfacing, or cosmetic surgery (including botulinum toxin injections) to the facial area within 24 weeks before the screening date
• Permanent skin augmentation implants such as hardened gel (Softform) or silicone in the facial area
• Skin diseases or wound infections in the facial area that would affect this investigation
• History of autoimmune disease
• Hypersensitivity to sodium hyaluronate
• History of streptococcal disease
• History of anaphylaxis or severe multiple allergies
• History of hypertrophic scars, hyperpigmentation or keloids
• Hypersensitivity to lidocaine or other amide local anesthetics
• Coagulation disorders
• Clinically significant disorders of the cardiovascular, digestive, respiratory, endocrine, or central nervous systems or a psychiatric illness that significantly affects this investigation
• Participated in another clinical investigation within 30 days before the screening date and received/applied an investigational drug/investigational medical device
• Female subjects of childbearing potential who do not agree to use a medically acceptable method of contraception* until 48 weeks after application of the investigational medical device in this investigation. (*Medically accepted methods of contraception include: condoms, oral contraception continued for at least 3 months, use of injectable or insertable contraceptives, intrauterine contraceptive devices, etc.)
• Pregnant or lactating women
• Used steroid medication for therapeutic purposes (immune diseases, musculoskeletal diseases, etc.) within 4 weeks prior to enrollment in the investigation, or plans to use steroid medication during the investigation period
• Used or intends to use functional cosmetics for wrinkle improvement within 4 weeks before participation in the investigation or during the investigation period
• In addition to the above, those who have clinical significant findings that are considered inappropriate for this investigation by the principal investigator or personnel in charge, based on medical judgment.