Study of a Novel Hyaluronic Acid Based Gel for Volume Deficiency in the Mid-face (FaceHyal)

Inclusion Criteria

• •Aged between 30 and 84 years.
• •Seeking correction of the mid-face volume deficit, and agrees with the recommendation of the Investigator.
• •Accept the obligation not to receive any other facial procedures or treatments impacting facial volume augmentation at any time during the study.
• •Able to follow study instructions and likely to complete all required visits, as assessed by the Investigator.
• •Psychologically able to understand the study related information and to give a written informed consent
• •Have voluntarily provided written informed consent to participate in the study, and use of data privacy (sign the ethics committee approved Informed Consent Form), prior to any study-related procedure being performed.
• •Female of childbearing potential (sexually active, not sterile, nor postmenopausal for at least 1 year) must have a negative urine pregnancy test (UPT) at Visit 1 (or Visit 1b), and use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study and for the duration of the study.
• •Affiliated to a health social security system.
• •Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders.
• •Subject with any history of healing disorders.
• •Subject having history of allergy or anaphylactic shock including hypersensitivity to hyaluronic acid, to lidocaine, or to antiseptic solution or any other amide type local anaesthetics.
• •Subject presenting a history of severe, evolutive, unstable, or recent allergies.
• •Subject suffering from porphyria.
• •Subject with a cancer in areas close to the injection site, and subjects with a melanoma
• •Subject with epilepsy or severe respiratory or cardiac function disorder.
• •Subject with severe renal or hepatic functions disorders.
• •Relating to previous or ongoing treatment:
• •Subject having received treatment with a laser or ultrasound, a dermabrasion, a surgery, a deep chemical peeling, or other ablative procedure on the midface area within the past 12 months prior to inclusion.
• •Subject having received injection with a resorbable filling product in the midface area, defined as the zygomaticomalar and the anteromedial cheek regions, within the past 18 months prior to inclusion.
• •Subject having received injection with a resorbable filling product in the nasolabial folds and/or the eye shadows, within the past 12 months prior to inclusion.
• •Subject having received injection with a resorbable filling product in any part of the body of more than 8 mL within the past 12 months prior to inclusion.
• •Subject having received at any time injection with a slowly resorbable filling product (e.g., polylactic acid, calcium hydroxyapatite, combinations of ha and hypromellose) or with a non-resorbable filling product (e.g. polyacrylamide or silicone).
• •Subject having received at any time a treatment with tensor threads in the Midface area, or a surgery in the mid-face, or who plan to undergo any of these procedures during the study.
• •Subject under medications which may cause lipo-atrophy.
• •Subject using medication that reduce or inhibit hepatic metabolism (cimetidine, beta-blockers, etc)
• •Subject being under immunosuppressive therapy.
• •Subject undergoing a topical treatment on the test area or a systemic treatment:
• •Antihistamines during the 3 days prior to study start
• •Immunosuppressors and/or corticoids during the 4 weeks prior to study start
• •Retinoids during the 6 months prior to study start.
• •Subject having received a covid vaccine less than 4 weeks before the IPN-21-SENSE injection