A 52-week Clinical Investigation of Princess® VOLUME PLUS Lidocaine in Subjects With Midface Volume Deficit

Exclusion Criteria

• •1. Presence or history of hypertrophic scarring, pigment disorders or keloid formation.
• •2. Presence or history of any autoimmune disease or current treatment with immune therapy.
• •3. History of hypersensitivity to hyaluronic acid, lidocaine hydrochloride or other amide-type local anaesthetics.
• •4. Previous treatment with a permanent filler in the area to be treated.
• •5. Pregnant or breastfeeding women.
• •6. Treatment with anticoagulants and platelet aggregation inhibitors (e.g., acetylsalicylic acid) within 10 days prior to Visit 1, unless the risk of bleeding/bruising is discharged after consultation with subject's physician who had prescribed such medicine.
• •7. Cutaneous, inflammatory and/or infectious processes (e.g., acne, herpes) in the area to be treated.
• •8. Laser therapy, dermabrasion or mesotherapy within 12 months, or chemical peeling within 3 months prior to Visit 1.
• •9. History of other aesthetic/surgical treatment which may interfere with performance evaluation.
• •10. Current or previous (within 30 days of enrolment) treatment with another investigational drug and/or medical device or participation in another clinical study.
• •11. Previous enrolment in this clinical investigation.
• •12. Any person dependent on the investigator (e.g., employees, relatives, or similar), or employees of the investigation site institution or the Sponsor.
• •13. The following subjects shall not participate: persons with a legal custodian appointed due to mental disability, prisoners, soldiers and other members of the armed forces, civil servants (for Austria this is specified in the Medical Devices Act).
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