Effectiveness and Safety of STYLAGE® HYDRO in the Treatment of Face, Neckline Area and Neck

Inclusion Criteria:

1. Healthy subject.
2. Sex: female.
3. Age: between 30 and 70 years.
4. Subject having given freely and expressly her informed consent and data privacyconsent.
5. Subject with signs of cutaneous dryness and lack of elasticity on the face, on theneckline area and if applicable on the neck (if neck is planned to be treated)following investigator assessment.
6. Subject willing to have photographs of the face, neck and neckline taken.
7. Subject psychologically able to understand the study related information and to give awritten informed consent.
8. Subject affiliated to a health social security system.
9. Subject agreeing not to receive another aesthetic procedure (e.g., laser,dermabrasion, surgery, deep chemical peeling, surface peel, tensor threads, injectionwith a filling product) on the face, the neckline area and if applicable on the neck (if neck is planned to be treated) during the whole study.
10. Female of childbearing potential should use a medically accepted contraceptive regimensince at least 12 weeks before screening visit and during the whole study.
11. Subject agreeing to keep their usual cleansing / care products during the whole studyperiod.
12. Subject agreeing to apply a SPF50 cream during non-intensive exposure to sunlight.

Exclusion Criteria:

1. Pregnant or breastfeeding woman or planning a pregnancy during the study.
2. Subject with a tattoo, a scar, moles, too many hairs or anything on the studied zoneswhich might interfere with the evaluation.
3. Subject who had been deprived of their freedom by administrative or legal decision orwho is under guardianship.
4. Subject in a social or sanitary establishment.
5. Subject participating to another research on human beings or who is in an exclusionperiod of one.
6. Subject having received 6000 euros indemnities for participation in researchesinvolving human beings in the 12 previous months, including participation in thepresent study. (France only)
7. Subject suffering from a severe or progressive disease or any other pathology that mayinterfere with the evaluation of the study results.
8. Subject suffering from autoimmune disease and/or immune deficiency.
9. Subject suffering from inflammatory and/or infectious cutaneous disorders in or nearthe studied zones (herpes, acne, mycosis, papilloma…). Subject with recurrent herpesis eligible if asymptomatic at time of inclusion.
10. Subject having history of hypersensitivity to hyaluronic acid or to one of thecomponents of the tested device, anaesthetic product or antiseptic solution.
11. Subject having history of anaphylactic shock or severe and/or evolutive / unstable /recent allergy.
12. Subject with a past history of streptococcal disease, such as acute rheumatic fever orrecurrent sore throats.
13. Subject predisposed to develop keloids or hypertrophic scars.
14. Subject prone to develop inflammatory skin conditions or having tendency to bleedingdisorders.
15. Subject having received treatment with a laser on the face, the neckline area or ifapplicable the neck within the past 6 months prior to screening visit.
16. Subject having received a superficial, medium, or deep peeling on the face, theneckline area or if applicable the neck within the past month, 3 or 12 monthsrespectively prior to screening visit.
17. Subject having received injection with a reticulated hyaluronic acid (HA), on theface, the neckline area or if applicable the neck within the past 12 months prior toscreening visit.
18. Subject having received injection with a non-reticulated hyaluronic acid (HA) orbotulinum toxin on the face, the neckline area or if applicable the neck within thepast 6 months prior to screening visit.
19. Subject having received at any time injection with a slowly resorbable filling product (polylactic acid, calcium hydroxyapatite, combinations of HA and hypromellose, HA anddextran microbeads or HA and TriCalcium Phosphate (TCP), …),a non-resorbable fillingproduct (polyacrylamide, silicone, combination of methacrylic polymers and collagen,polymer particles, …) or tensor threads on the face, the neckline area or ifapplicable the neck.
20. Subject having started or changed her oral contraceptive or any other hormonaltreatment during 12 weeks prior to screening visit.
21. Subject using medication such as aspirin, NSAIDs (ibuprofen, ketoprofen, naproxen…),platelet aggregation inhibitors, anticoagulants, vitamin C within one week prior toinjection visit (V1) and agreeing not to take such treatments within 1 week prior tothe second (V2) and third injections (V3).
22. Subject having history of immunosuppressors taking.
23. Subject undergoing a topical treatment on the test area or a systemic treatment:

• Anti-histamines during the 3 days prior to injection visit (V1) and agreeing notto take such treatment during the study as far as possible;
• Corticoids during the 4 weeks prior to screening visit;
• Retinoids during the 6 months prior to screening visit.

24. Subject having changed her topical cleansing / care products within the month prior toscreening visit.
25. Intensive exposure to sunlight or UV-rays within the previous month and foreseenduring the study.