Evaluation of the Safety and Efficacy of Profhilo® Structura

Inclusion Criteria:

1. Healthy subjects

2. Male and Female subjects.

3. Age : between 35 and 55 year

4. Subject having given freely and expressly his/her informed consent obtainedaccording to ISO 14155:2020 and Good Clinical Practice (GCP)

5. Only for treated group: Subject seeking aesthetic improvement for acorrective/filling action of natural and induced skin depressions

6. Women of childbearing potential must have a negative urine pregnancy test result atinclusion visit and must use a reliable method of contraception since at least 12weeks and throughout the study.

7. Subject psychologically able to understand the information related to theinvestigation including possible risks and side effects.

8. Subject able to cooperate with the Investigator and to comply with the requirementsof the entire investigation (including ability to attend all the plannedinvestigation visits according to the time limits), based on investigator'sjudgement.

9. Subject agreeing to keep their usual cleansing / care products during the wholestudy period.

10. Subject agreeing to apply a SPF50 cream during the whole study period.

Exclusion Criteria:

In terms of population

1. Pregnant or breastfeeding woman or planning a pregnancy during the study.

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

3. Subject in a social or sanitary establishment.

4. Subject enrolled in another study or whose non-enrollment period is not over.

5. For France only: subject having received a total of 6.000 euros as compensations fortheir participation in the present study.

6. Subject disagrees to keep a stable weight during the study (BMI variation ± 1)

7. Subject with high expectations for the treatment effect. In terms of associated pathology

8. Subject suffering from a severe or progressive disease or any other pathology thatmay interfere with the evaluation of the study results and/or subject safety

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

10. Subject suffering from active disease such as inflammation, infection, tumour,inflammatory and/or infectious cutaneous disorders (herpes, acne, rosacea,porphyria...) in the 6 months before screening visit

11. Subject with a history of streptococcal disease or an active streptococcus infection

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

13. Subject predisposed to keloids or hypertrophic scarring or having healing disorders

14. Subject having history of severe allergy or anaphylactic shock including known riskof hypersensitivity to one of the components of the composition of theinvestigational device and to antiseptic solution related to previous or currenttreatment.

15. Subjects with scar, mole, hair or local skin infection (including viral, bacterial,and fungal); skin granulomas; scar constitution; immune system disorders; presenceof active or progressive skin disorders or skin diseases with isomorphic response inthe treatment area, such as acute eczema, flat wart, lichen planus, psoriasisvulgaris, etc...

16. Patients with psychiatric disorders or emotional instability. In terms of previous or ongoing treatment or procedure

17. Any medication which may interfere, at the interpretation of the investigator, withthe study objectives.

18. Subject having undergone tooth extraction or dental implant procedure within thepast 6 weeks or plans to undergo these procedures during the study.

19. Subject having received facial or cervico-facial lifting in the past 24 months orplans to undergo these procedures during the study.

20. Subject having received treatment with a laser, ultrasound or radiofrequencytreatment, a dermabrasion, a surgery, a chemical peeling or any other procedurebased on active dermal response on the face within the past 6 months or who plans toundergo any of these procedures during the study.

21. Subject having received within the past 18 months or planning to receive during thestudy any injections outside of those in the study protocol including non-permanentfillers (e.g., HA, Calcium Hydroxyapatite) or autologous fat on or near the face.

22. Subject having received within the past 9 months or planning to receive during thestudy any injections outside of those in the study protocol including mesotherapy orbotulinum neurotoxin on or near the face.

23. Subject having received at any time or planning to receive a permanent filler on theface (e.g., polylactic acid, Polymethylmethacrylate, silicone) during the study.

24. Subject with subcutaneous retaining structure on the face (meshing, threads, goldstrand).

25. Subject having received in the last 24 months resorbable threads lift on the face.

26. Subject having received at any time injection with unknown products

27. Subject using medication such as aspirin, high dose Vitamin C, nonsteroidalanti-inflammatory drugs (NSAIDs), antiplatelet agents, thrombolytics oranticoagulants within one week prior to injection visit or being a chronic user.

28. Subject using medication such as narcotic, and immunosuppressive drugs from threeweeks before screening visit and during the whole study period

29. Subject having started or stopped an antidepressant 3 weeks prior the study or plansto use it during the study.

30. Subject undergoing a topical treatment on the face or a systemic treatment:

• anti-inflammatory medication and/or antihistamines within the past 2 weeks andduring the study,

• corticosteroids within the past 2 weeks and during the study,

• retinoids and/or immunosuppressors within the past 3 months and during thestudy. In terms of lifestyle

31. Intensive exposure to sunlight or UV-rays within the previous month and/or planningto do so during the study.

32. Heavy smoker (subject who reports smoking 10 or more cigarettes per day);

33. Subject with an excessive consumption of alcohol (more than 2 glasses of wine perday)