Evaluation of the Safety and Performance of an Injectable Hyaluronic Acid Filler

Exclusion Criteria

• •Anything on the treatment site which might interfere with the evaluation (tattoo, scar, moles, too many hairs).
• •Subject with mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy (e.g., juvenile dermatomyositis), partial lipodystrophy (e.g., Barraquer-Simons syndrome), inherited disease, or HIV-related disease, and/or severe malocclusion or dentofacial or maxillofacial deformities.
• •Known history of multiple allergies, allergic/anaphylactic reactions including allergy to lidocaine or anaesthetics of the amide type, to hyaluronic acid products, or to Grampositive bacterial proteins.
• •History or current autoimmune disease and/or immune deficiency.
• •History of streptococcal disease (such as acute rheumatic fever or recurrent sore throats), precancerous lesions/skin malignancies, hyper- or hypo-pigmentation in face.
• •Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders.
• •Received (or is planning to receive) anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti-inflammatory drugs \[oral/injectable corticosteroids or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs, e.g., aspirin, ibuprofen)\], or other substances known to increase coagulation time from 10 days pre- to 3 days post injection \[Study device injections may be delayed as necessary to accommodate this 10-day washout period.\]
• •Have received at any time permanent facial implants (e.g. polyacrylamide, silicone) anywhere in the face or neck.
• •Botulinum toxin injections, mesotherapy, or resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or other ablative or non-ablative procedures) within 6 months prior to entry in the study.
• •Have received injection with a temporary bioresorbable facial dermal filler (e.g., hyaluronic acid, collagen, autologous fat, etc.) within the past 12 months prior to study start.
• •Have undergone semi-permanent dermal filler treatment (e.g., calcium hydroxylapatite, poly-L-lactic acid, etc.) in the face within 24 months before enrolment.
• •Have received at any time a treatment with tensor threads or gold strands on the face.
• •Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen during the study.