Medical Device Pivotal Study to Injection With SkinPlus-HYAL Implant Lidocaine vs RESTYLANE Lidocaine in of Nasolabial Folds (BPLUS-02)

Bioplus Life Sciences

Status

Invitation-only

Conditions

Nasal Disease

Nasal Surgery

Treatments

Device: Investigational medical device (SkinPlus-HYAL Implant Lidocaine)

Device: Active Comparator: Active Comparator Medical Device (RESTYLANE Lidocaine)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06305520

CRIS NO. : KCT0008113 (Registry Identifier)

BPLUS-NASAL-02

Details and patient eligibility

About

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).

Enrollment

100 estimated patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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.