Multicenter, Prospective Study to Determine the Performance and Safety of the New M-HA30 Architect Device on the Quality of the Skin: HEBE8 Study

Inclusion criteria

• Male or female subjects except for injections on the décolleté that will only concern women
• From 19 to 84 years old
• Who has signed a written informed consent;
• With a Fitzpatrick phototype of I, II, III or IV
• Having on both sides, one of the 3 following conditions:

• For Face: a wrinkle score according to Lemperle scale of 2, 3 or 4 at the level of the cheeks
• For Neck: a Grade 2, 3 or 4 on Bazin Neck Wrinkle Scale
• For Decollte: a Grade 2 or 3 on Landau Décolleté Wrinkle Scale
• Registered with Social Security (for France)
• Accepting not to expose him/herself to the sun or ultraviolet (UV) during the entire duration of the study.
• For female of childbearing potential accepting to take a pregnancy test (a pregnancy test will be performed before each injection) and a highly effective contraception* method during whole study.

Exclusion criteria

• Subject involved in any other clinical study evaluating drugs or medical devices, including devices without an intended medical purpose, or subjects in exclusion periods of another clinical study.
• Deprived of freedom by an administrative or legal decision.
• Unable to follow protocol requirements.
• Who has received compensation of 4500 € during the 12 previous months for his/her participation in clinical trials (including participation in this study / for France).
• Having benefit from injection/facial implantation of any non-absorbable filling agent at any time of his/her life.
• Having already had laser sessions for skin rejuvenation or a laser facelift in the previous year or a facelift by surgery in the 2 years prior to the study.
• With a history of absorbable fillers injections (such as hyaluronic acid) in the last year or botulinum toxin in the last 6 months or the injectable implants (semi-permanent fillers) in the last two years.
• With a skin support device (wire mesh, gold wire, liquid silicone or other particulate material, absorbable or non-absorbable threads) at the study zones.
• Having done a moderate to deep peeling or non-invasive rejuvenation techniques such as radiofrequency, ultrasound and lasers in the last 6 months.
• With a history of multiple severe allergies or anaphylactic shock.
• With a known hypersensitivity to hyaluronic acid, or other components of M-HA®30 Architect and Profhilo®.
• With a known hypersensitivity to the disinfection products such as chlorhexidine and betadine.
• With a known hypersensitivity to lidocaine or to local amide-type anesthetics.
• Prone to developing inflammatory skin conditions or hypertrophic scarring according to investigator judgement.
• With a history of streptococcal diseases (angina recurrent, rheumatic fever).
• Under concomitant treatment (or not stopped for at least 3 months) by oral or injectable corticosteroid (inhaled corticosteroids are allowed as well as a topical corticotherapy not involving the study zones).
• Under concomitant treatment (or not stopped for at least 1 year) by immunosuppressive or chemotherapy treatments.
• With a history of less than one year of radiation therapy in the investigated areas.
• With an associated antecedent or pathology of autoimmune or connective tissue disease.
• Presenting a skin pathology, an acute inflammatory reaction or a bacterial or viral infection on the study zones or within the 6 weeks after the end of such an episode.
• With heart disease and/or undergoing treatment for heart disease (beta-blockers)
• With congenital glucose-6-phosphate dehydrogenase deficiency or idiopathic methemoglobinemia
• With hepatocellular insufficiency and/or undergoing treatment for liver disease
• With porphyria
• Having taken aspirin or anticoagulants, at regular doses, in the last 15 days preceding the act.
• That has been exposed to sun or UV in the last 15 days.
• With a dermatological condition or inflammation at the treatment zone or near to this area (according to the investigator's judgment).
• Pregnant or lactating woman (Before every injection, a urinary pregnancy test will be performed).
• Having epilepsy uncontrolled by treatment.
• Presenting a general pathology, skin pathology, dermatosis, systemic, chronic or acute disease and/or topical or general treatment that in the opinion of the investigator may interfere with the treatment or compromise the participation of the subject in the study.
• With a COVID vaccination plan of any dose with any kind of vaccine at 3 weeks before or 3 weeks after each injection session.
• With a history of COVID infection in the last 4 weeks and still have a positive test and/or the raised inflammatory markers such as ferritin, CRP, IL-8, D-Dimer, etc. (blood results will only be requested for volunteers with a severe form of the disease, i.e. one that required medical intervention or hospitalization).