Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT06305520
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT06305520
Study Brief:
Protocol Section:
NCT06305520