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

Exclusion Criteria

• •1. 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.
• •2. Deprived of freedom by an administrative or legal decision.
• •3. Unable to follow protocol requirements.
• •4. 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).
• •5. Having benefit from injection/facial implantation of any non-absorbable filling agent at any time of his/her life.
• •6. 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.
• •7. 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.
• •8. With a skin support device (wire mesh, gold wire, liquid silicone or other particulate material, absorbable or non-absorbable threads) at the study zones.
• •9. Having done a moderate to deep peeling or non-invasive rejuvenation techniques such as radiofrequency, ultrasound and lasers in the last 6 months.
• •10. With a history of multiple severe allergies or anaphylactic shock.
• •11. With a known hypersensitivity to hyaluronic acid, or other components of M-HA®30 Architect and Profhilo®.
• •12. With a known hypersensitivity to the disinfection products such as chlorhexidine and betadine.
• •13. With a known hypersensitivity to lidocaine or to local amide-type anesthetics.
• •14. Prone to developing inflammatory skin conditions or hypertrophic scarring according to investigator judgement.
• •15. With a history of streptococcal diseases (angina recurrent, rheumatic fever).
• •16. 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).
• •17. Under concomitant treatment (or not stopped for at least 1 year) by immunosuppressive or chemotherapy treatments.
• •18. With a history of less than one year of radiation therapy in the investigated areas.
• •19. With an associated antecedent or pathology of autoimmune or connective tissue disease.
• •20. 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.
• •21. With heart disease and/or undergoing treatment for heart disease (beta-blockers)
• •22. With congenital glucose-6-phosphate dehydrogenase deficiency or idiopathic methemoglobinemia
• •23. With hepatocellular insufficiency and/or undergoing treatment for liver disease
• •24. With porphyria
• •25. Having taken aspirin or anticoagulants, at regular doses, in the last 15 days preceding the act.
• •26. That has been exposed to sun or UV in the last 15 days.
• •27. With a dermatological condition or inflammation at the treatment zone or near to this area (according to the investigator's judgment).
• •28. Pregnant or lactating woman (Before every injection, a urinary pregnancy test will be performed).
• •29. Having epilepsy uncontrolled by treatment.
• •30. 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.
• •31. With a COVID vaccination plan of any dose with any kind of vaccine at 3 weeks before or 3 weeks after each injection session.
• •32. 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).