Evaluating the Performance and Safety of the Medical Device Auralya® in the Treatment of Facial Dermal Tissue Defects

Exclusion Criteria

• •1. Past or current bleeding disorders.
• •2. Use of aspirin and antiplatelet agents a week prior to treatment.
• •3. Prior or planned use of topical injection to the face (steroid, retinoid: applicable only to drugs, not applicable to cosmetics), within 4 weeks prior to screening or during this study (steroid ointment for therapeutic objectives is allowed for short -term use of ≤14 consecutive days.).
• •4. Use of immunosuppressive, chemotherapies, or systemic corticosteroids within 12 weeks from screening.
• •5. History of anaphylaxis or severe complicated allergy symptoms.
• •6. Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders or previous mental disorders that may significantly affect the study.
• •7. Known hypersensitivity skin reaction to hyaluronic acid or hypersensitivity skin reaction to the investigational device based on intradermal test results at visit 1.
• •8. Evidence or history of autoimmune disease or compromised immune system.
• •9. Treatment with anticoagulants, thrombolytics, or platelet inhibitors within 1 week prior to study participation.
• •10. Prior permanent fillers or fat graft procedures around facial dermal tissue defects.
• •11. Facial dermal tissue defects correction procedures (e.g., botulinum toxin A injection, face lift, soft tissue augmentation, medium-depth peel, dermal photo-rejuvenation, etc.) around infraorbital region within 6 months prior to study participation.
• •12. History of hypersensitivity to local anaesthetic of amide type or HA.
• •13. History of keloid formation or hypertrophic scar on the face.
• •14. Evidence of active infection on the face.
• •15. Wound, skin disorder or infection around facial dermal tissue defects that may affect the efficacy assessment.
• •16. Pregnant woman, lactating woman, and man or woman of childbearing potential who is planning a pregnancy or is unwilling to use appropriate methods of contraception\* during the study. \*Methods of contraception: hormonal contraceptive, intrauterine device or intrauterine system, double barrier method (condom with spermicide/diaphragm or cervical cap with spermicide), surgical sterilization (vasectomy, tubal ligation, etc.).
• •17. Need to exposure to the sun, UV rays and extreme conditions of heat for at least a week after the treatment.
• •18. Need to have direct or indirect contact with quaternary ammonium salts during the study.
• •19. As with all dermal filler procedures, the product should not be used in vascular rich areas. Using the product at sites such as Glabella and nose may inadvertently be injected into the blood vessels, resulting in symptom of vessel occlusion such as colour vision deficiency and blindness.
• •20. Patients with illness, or other medical condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the study.
• •21. Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.