medical device pivotal study to injection with skinplus-hyal implant lidocaine vs restylane lidocaine in of nasolabial folds

Conditions: Nasal Disease; Nasal Surgery

Summary: 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).


Eligibility criteria:
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.

Keywords: nasolabial fold filler medical device