A Study in Adults Evaluating Polycaprolactone Microsphere Filler for Treatment of Moderate to Severe Nasolabial Folds

Exclusion Criteria

• •1. Allergy to polycaprolactone, hyaluronic acid products or any component of the investigational device or control device(such as streptococcal proteins), allergy to any local anesthetic (such as lidocaine or other amide-typeanesthetic), or history of severe allergic reactions and multiple severe allergic reactions.
• •2. Previous surgery, cosmetic facial procedure, or plans to undergo cosmetic surgery in NLF area or lower face during the trial, inculding any of the following circumstances:
• •1. Received permanent fillers or prostheses (such as PMMA etc.) or semi-permanent dermal fillers (such as CaHA, PLLA, PCL, etc.).
• •2. Received temporary dermal fillers (such as HA and collagen etc.) within 12 months prior to screening.
• •3. Received anti-wrinkle surgery within 12 months prior to screening.
• •4. Receiving botulinum toxin injection, chemical stripping, radiofrequency laser, and liquid nitrogen freezing anti-wrinkle treatment within 6 months.
• •3. Individuals who used topical agents (e.g., corticosteroids, steroids \[excluding hydrocortisone\], retinoids, or retinoid derivatives intended as medications but not as cosmetics) on the mid-to-lower facial area within 3 months prior to screening or plan to use them during the trial period, as well as those undergoing hydrocortisone treatment.
• •4. Individuals with abnormal coagulation mechanisms \[activated partial thromboplastin time (APTT) \>1.5 times the upper limit of normal (ULN), etc.\], or use of anticoagulants (e.g., warfarin, rivaroxaban), antiplatelet agents (e.g., aspirin, clopidogrel), thrombolytic agents (e.g., recombinant human urokinase) within 2 weeks prior to screening.
• •5. Individuals with severe liver or kidney dysfunction, such as liver function markers (ALT, AST) exceeding 2 times the ULN or kidney function markers (creatinine) exceeding 1.5 times the ULN.
• •6. Individuals with infectious diseases, including any positive test results for hepatitis B surface antigen, hepatitis C antibodies, HIV antibodies, or syphilis antibodies.
• •7. Individuals with scars, unhealed wounds, deformities, defects, tattoos, or excessive pigmentation in the nasolabial fold area that may affect the efficacy assessment.
• •8. Individuals with tumors, precancerous lesions, active skin lesions such as herpes, in the nasolabial fold area.
• •9. Individuals with acute or chronic skin diseases such as infections or inflammation in the treatment area.
• •10. Individuals with autoimmune diseases, such as psoriasis.
• •11. Individuals with uncontrolled diabetets.
• •12. Individuals prone to scarring, keloid formation, or hypertrophic scars.
• •13. Individuals diagnosed with psychiatric disorders, lacking self-autonomy, or experiencing active episodes of anxiety or depression.
• •14. Individuals with excessively high expectations of treatment outcomes or unwilling to accept potential short-term side effects such as bruising, swelling, or pain.
• •15. Individuals who are pregnant, breastfeeding, or unwilling to use medically approved contraception (e.g., oral contraceptives, condoms, intrauterine devices) during the trial.
• •16. Individuals who participated in other drug or medical device clinical trials within 3 months prior to screening.
• •17. Individuals deemed unsuitable for trial participation by the investigator for other reasons.