Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT07007351
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subjects except for injections on the décolleté that will only concern women
2. From 19 to 84 years old
3. Who has signed a written informed consent;
4. With a Fitzpatrick phototype of I, II, III or IV
5. 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
6. Registered with Social Security (for France)
7. Accepting not to expose him/herself to the sun or ultraviolet (UV) during the entire duration of the study.
8. 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:
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
84 Years
Study:
NCT07007351
Study Brief:
Protocol Section:
NCT07007351