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 therecommendation of the Investigator.

• Accept the obligation not to receive any other facial procedures or treatmentsimpacting facial volume augmentation at any time during the study.

• Able to follow study instructions and likely to complete all required visits, asassessed by the Investigator.

• Psychologically able to understand the study related information and to give awritten informed consent

• Have voluntarily provided written informed consent to participate in the study, anduse 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 postmenopausalfor at least 1 year) must have a negative urine pregnancy test (UPT) at Visit 1 (orVisit 1b), and use a medically accepted contraceptive regimen since at least 12weeks before the beginning of the study and for the duration of the study.

• Affiliated to a health social security system.

Exclusion Criteria:

In terms of population:

• Pregnant or breastfeeding woman, or planning a pregnancy during the study.

• Scars, moles, tattoo, or anything on the Mid-face which might interfere with theevaluation.

• Subject who had been deprived of their freedom by administrative or legal decisionor who is under guardianship.

• Subject in a social or sanitary establishment.

• Subject participating to another research on human beings or who is in an exclusionperiod of one.

• Subject having received 4,500 Euros in indemnities for participation in researchinvolving human beings in France in the past 12 months, including participation inthe present study (for France only).

In terms of associated pathology:

• Subject presenting any symptom which can be related to a medical condition that islikely to make the subject not being compliant with the study schedule, at thediscretion of the investigator.

• Subject suffering from a severe or progressive disease or any other pathology thatmay interfere with the evaluation of the study results.

• Subject with known history of or suffering from autoimmune disease and/or immunedeficiency.

• Subject suffering from active inflammatory and/or infectious cutaneous disorders inor near the studied zones (e.g., herpes, acne). Subject with recurrent herpes in theMidface area is eligible if asymptomatic at time of inclusion.

• Subject prone to develop inflammatory skin conditions or having tendency to bleedingdisorders.

• Subject with any history of healing disorders.

• Subject having history of allergy or anaphylactic shock including hypersensitivityto hyaluronic acid, to lidocaine, or to antiseptic solution or any other amide typelocal 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 amelanoma

• 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, asurgery, a deep chemical peeling, or other ablative procedure on the midface areawithin the past 12 months prior to inclusion.

• Subject having received injection with a resorbable filling product in the midfacearea, defined as the zygomaticomalar and the anteromedial cheek regions, within thepast 18 months prior to inclusion.

• Subject having received injection with a resorbable filling product in thenasolabial folds and/or the eye shadows, within the past 12 months prior toinclusion.

• Subject having received injection with a resorbable filling product in any part ofthe 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 fillingproduct (e.g., polylactic acid, calcium hydroxyapatite, combinations of ha andhypromellose) or with a non-resorbable filling product (e.g. polyacrylamide orsilicone).

• Subject having received at any time a treatment with tensor threads in the Midfacearea, or a surgery in the mid-face, or who plan to undergo any of these proceduresduring 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-SENSEinjection