Saypha® VOLUME Lidocaine for Midface Augmentation

Inclusion Criteria: (baseline treatment)

• Male or female subjects aged 22 - 75 years (inclusive) of age at Screening.
• Subjects with bilateral, approximately symmetric moderate to severe midface volume deficit (severity scores of 2 or 3 on the 5-point Midface Volume Deficit Severity Scale), as assessed by the blinded investigator at the site.
• Females of childbearing potential must have a negative urine pregnancy test and must agree to use an effective method of birth control throughout the entire study. Male subjects with female partners of child-bearing potential must agree to use contraception throughout the entire study (surgical sterilization or a physical barrier such as a condom).
• Healthy skin in the midface area and free of diseases that could interfere in cutaneous aging evaluation.
• Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of entire investigation, including botulinum toxin injection (except glabella or forehead botulinum toxin treatment).
• Subjects who understand the purpose and conduct of the study and having given written informed consent and are willing and able to attend the study visits as judged by the investigator.

Exclusion Criteria: (baseline treatment)

• Females, who are pregnant and/or, lactating or planning to become pregnant during the clinical investigation
• History of severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies
• History of hypersensitivity to hyaluronic acid preparations, lidocaine or any amide-based anesthetic
• Tendency to keloid formation and/or hypertrophic scars and/ or have pigment disorders
• Known human immune deficiency virus-positive individuals
• Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous lesions in the treatment area
• Re-current (three times a year over the last year) herpes simplex in the treatment area
• History or presence of any autoimmune or connective tissue disease, or current treatment with immuno-modulating therapy
• Uncontrolled (or unstable) Diabetes mellitus or systemic diseases as per investigator discretion
• Previous facial plastic surgery, tissue augmentation with silicone, fat or another non-absorbable substance (permanent fillers) and semi-permanent / long-lasting fillers (e.g., poly-L-lactic acid (PLLA), Polymethylmethacrylate (PMMA) filler) in the area of device application and during the entire investigation
• Implantation of dermal fillers in the treatment area within the preceding 24 months prior to Visit 1 (Screening) and during the entire investigation
• Subject has received any of the following aesthetic treatments in the midface area: e.g., laser therapy, absorbable and non-absorbable sutures (threads), dermabrasion, mesotherapy, micro-needling and/or botulinum toxin (including treatment of crow´s feet in the outer eye region) within the last 12 months prior to Visit 1, chemical peeling within the last three months prior to Visit 1 or is planning to undergo such procedures during entire investigation.
• Facial lipolysis, including submental fat treatments, within the previous 12 months prior to Visit 1 (Screening) and during the entire investigation
• Bariatric surgery within 12 months prior to Visit 1 (Screening) and during the entire investigation
• History of bleeding disorder and/or use of anticoagulant, antiplatelet, thrombolytic medication, or anti-inflammatory drugs (oral/injectable corticosteroids or non steroidal anti-inflammatory drugs, e.g., Motrin® or Advil®) or other substances known to increase coagulation time (vitamins or herbal supplements, e.g., St. John's Wort, high doses of vitamin E supplements) from ten days pre- to seven days post injection (baseline treatment and touch-up treatment)
• Planned dental/oral surgery or modification (bridge-work, implants) within four weeks prior to each injection and to a minimum of four weeks post injection