Post Market Study Evaluating Princess Filler Lidocaine for the Correction of Nasolabial Folds

Exclusion Criteria

• •Subjects meeting any of the following criteria should not be enrolled:
• •1. Pregnancy, lactation, planned pregnancy or unwillingness to use contraception at any time during the study (for women of child-bearing potential only)
• •2. History of mental disorders or emotional instability
• •3. History of allergic reaction or hypersensitivity to hyaluronic acid, lidocaine, or any amide-based anaesthetic
• •4. Presence of silicone implant or another non-absorbable substance (permanent fillers) in the nasolabial region
• •5. Facial surgery or implantation of dermal fillers, absorbable and non-absorbable sutures, laser therapy, dermabrasion, or botulinum toxin application in the nasolabial region within previous twelve months, or chemical peeling within previous three months, or planning to undergo such procedures in the treatment area during the study
• •6. Presence of infectious, inflammatory, or proliferative lesions in the nasolabial region
• •7. Cutaneous lesions in the treatment area
• •8. Known human immune deficiency virus-positive individuals
• •9. History of allergies against aesthetic filling products and recurrent herpes simplex
• •10. Tendency to hypertrophic scars, keloid formation and/or pigmentation disorders
• •11. History or presence of any autoimmune or connective tissue disease, or current treatment with immune therapy
• •12. Diabetes mellitus or uncontrolled systemic diseases
• •13. Use of anticoagulant, antiplatelet or thrombolytic medication from ten days pre- to three days post injection
• •14. Any medical condition which, in the investigator's opinion, prohibits the inclusion in the study
• •15. Current or previous (within 30 days of enrolment) treatment with another investigational drug and/or medical device or participation in another clinical study
• •16. Previous enrolment in this clinical investigation
• •17. Subjects whose participation in clinical trials is prohibited by the Austrian Medical Devices Act (e.g., persons with a legal custodian appointed due to mental disability, prisoners, soldiers and other members of the armed forces, civil servants)