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

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.