To Evaluate the Efficacy and Safety of 'BRDE33-100' for the Temporary Correction of Moderate to Severe Nasolabial Folds

Exclusion Criteria

• •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