Clinical Evaluation of the Safety and Performance of a Filler in Correction of Mid-face Age-related Volume Deficit

Exclusion Criteria

• •1. Pregnant or nursing woman or planning a pregnancy during the study.
• •2. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
• •3. Subject in a social or sanitary establishment.
• •4. Subject participating to another research on human beings or being in an exclusion period for a previous study.
• •5. Subject having received 4500 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the present study.
• •6. Intensive exposure to sunlight or UV-rays within the previous month and foreseen during the study.
• •7. Subject with a tattoo, a scar, moles, pigment disorders or anything on the studied zones which may interfere with the study at the investigator appreciation.
• •8. Subject with unstable weight or planning to do a dietary regime during the study.
• •9. Subject with too severe mid-face volume deficit.
• •10. Subjects without teeth or with dental prostheses
• •11. Subject with severe, ongoing and uncontrolled diseases such as malignancy or history of malignancy, type I diabetes, liver failure, renal failure, lung/heart disease, neoplasia, malignant blood disease, tumor, HIV, epilepsy, porphyria or other major disease, likely to interfere with the measured parameters or to put the subject to an undue risk.
• •12. Subject with known history of or suffering from autoimmune disease and/or immune deficiency
• •13. Subject with current cutaneous inflammatory or infectious processes (eg, acne, herpes, mycosis, papilloma, chronic eczema, atopic dermatitis …), abscess, unhealed wound, or a cancerous or precancerous lesion on the studied zone.
• •14. Subject having history of anaphylactic shock or know allergy or hypersensitivity to hyaluronic acid or to one of the components of the tested device, antiseptic solution, lidocaine hydrochloride or to amide-type local anaesthetics.
• •15. Subject predisposed to keloids or hypertrophic scarring.
• •16. Subject with coagulation and/or homeostasis disorders.
• •17. Subject with a past history of streptococcal disease, such as acute rheumatic fever or recurrent sore throats;
• •18. Subject having received treatment with a laser, a dermabrasion, a surgery, a chemical peeling, mesotherapy or other ablative procedure on the face within the past 12 months prior to inclusion;
• •19. Subject having received injection with a reabsorbable filling product in the face area within the past 12 months prior to inclusion;
• •20. Subject having received at any time injection with a slowly reabsorbable filling product (polylactic acid, calcium hydroxyapatite, combinations of hyaluronic acid (HA) and hypromellose, HA and dextran microbeads or HA and TriCalcium Phosphate (TCP), …) or with a non-resorbable filling product (polyacrylamide, silicone, combination of methacrylic polymers and collagen, polymer particles, …);
• •21. Subject having received at any time a treatment with suspension threads in the face;
• •22. Any medication which may interfere, at the interpretation of the investigator, with the study objectives in term of efficacy and safety.
• •23. Subject under medications which may cause lipoatrophy;
• •24. Subject using medication such as aspirin, NSAIDs (ibuprofen, naproxen, …), antiplatelet agents, anticoagulants, high-doses vitamin C within 10 days prior to inclusion or being a chronic user;
• •25. Subject having received chemotherapy agents, immunosuppressive medications or systemic corticosteroids within 3 months of enrolment and during the study.