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 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT07069920
Eligibility Criteria:
Inclusion Criteria: All of the following inclusion criteria must be met for a subject to be enrolled in this clinical trial.
* Male or female subjects aged between 19 and 75 years, inclusive, as of the date of written informed consent.
* Voluntarily decided to participate in the study and signed the informed consent form in writing
* Subjects who desire improvement in nasolabial folds and have a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4.
* Subjects whose bilateral nasolabial folds appear visually symmetrical, although WSRS scores do not need to be identical on both sides.
* Subjects who agree to use appropriate contraception from the date of signing the informed consent form until 3 months after the end of the clinical trial. \*Examples of acceptable contraception include: copper intrauterine device (IUD), hormone-releasing IUD, condoms, vasectomy, tubal ligation, spermicides, vaginal contraceptive film, subdermal implants, injectable contraceptives, female condoms, and oral contraceptives.
* Subjects who agree not to undergo any procedures or treatments that may affect the nasolabial folds during the study period.
* Subjects who are able to understand and comply with the study instructions and are available for the entire duration of the study.
Exclusion Criteria: Subjects who meet any of the following exclusion criteria will not be eligible for participation in this clinical trial.
* Received antithrombotic agents (except for low-dose aspirin \[100 mg, up to 300 mg/day\]) or nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to screening
* Used topical agents on the device application area within 4 weeks prior to screening or plans to use them during the study period, including corticosteroids, retinoids, alpha hydroxy acids, skin-whitening agents, or anti-wrinkle functional cosmetics. (- Topical corticosteroids for therapeutic purposes may be used for a short duration of up to 14 consecutive days.)
* Received invasive laser treatment, deep peeling procedures, or filler injections on the device application area within 24 weeks prior to screening.
* Received any wrinkle improvement procedures on the device application area within 24 weeks prior to screening, including:
* Botulinum toxin injections
* Soft-tissue augmentation
* Facial lifting surgery
* Dermabrasion
* Dermal photo-rejuvenation
* Received any wrinkle improvement procedures on the device application area within 1 year prior to screening, including facial augmentation using calcium hydroxylapatite or wrinkle treatment using approved fillers.
* Received an injection of calcium hydroxylapatite in the nasolabial fold area within 1 year prior to screening.
* Has permanent dermal implants such as Softform or silicone in the nasolabial fold area.
* Underwent facial lifting involving thread-based tissue fixation (e.g., thread lifting) that affected the nasolabial fold area within 1 year prior to screening
* Has taken medications that may affect skin hypersensitivity testing, including:
① First- or second-generation antihistamines (e.g., chlorpheniramine, hydroxyzine, cetirizine, fexofenadine, loratadine) within 7 days prior to screening
② Tricyclic antidepressants (e.g., imipramine, doxepin) within 11 days prior to screening
③ H2-receptor antagonists (e.g., ranitidine) within 1 day prior to screening
* Has scars, skin disorders, wounds, infections, inflammation, or other skin lesions in the nasolabial fold area that may affect the outcome of this clinical trial.
* Has a history of anaphylaxis or severe systemic allergic reactions.
* Has a history of hypertrophic scarring, keloid formation, or hyperpigmentation.
* Has a known hypersensitivity to Hyaluronic acid (HA).
* Has experienced adverse reactions to EMLA Cream or other lidocaine-based anesthetic products.
* Has or has had autoimmune diseases including AIDS, or is immunocompromised.
* Has clinically significant disorders of the cardiovascular, gastrointestinal, respiratory, endocrine, or central nervous systems, or has psychiatric conditions that may affect participation in this clinical trial.
* Tested positive on the skin hypersensitivity test indicating hypersensitivity to the investigational device or control device at the time of screening.
* Participated in other clinical trial(s) within 30 days prior to screening
* Pregnant or breast-feeding women (women of childbearing potential must undergo a pregnancy test)
* Subjects who, due to physical, neurological, or psychological conditions, are unable to comply with all aspects of the screening, evaluation, treatment, and follow-up schedule.
* Subjects who are otherwise unable to communicate or follow instructions properly.
* Determined by the principal investigator to be unable to participate in the study for other reasons
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
75 Years
Study:
NCT07069920
Study Brief:
Protocol Section:
NCT07069920