HYDRELAA Prospective, Monocentric, Intra-individual, Randomized Clinical Investigation to Evaluate the Efficacy and Safety of Stylage® HydroMax on Skin Moisturization and Elasticity

Date de début de l'étude : 3 septembre 2019

Inclusion Criteria: * Healthy subject. * Female between 35 and 65 years. * Having given freely and expressly her informed consent. * With signs of cutaneous dryness on the cheeks and neckline area (checked by measurements using Corneometer® \<60 arbitrary unit (AU) on each cheek). * With signs of a mild to moderate lack of elasticity on face and neckline area following investigator assessment. * Psychologically able to understand the study related information and to give a written informed consent. * Affiliated to a health social security system. * Female of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study and during all the study. * Agreeing not to change any hormonal treatment (including contraceptive treatment) during the whole study. * Agreeing to keep their usual cleansing / care products during the whole study period. * Agreeing to apply a sun protection factor SFP50 cream during non-intensive exposure to sunlight. Exclusion Criteria: * Pregnant or nursing woman or planning a pregnancy during the study. * With a tattoo, a scar, moles, too many hairs or anything on the studied zones which might interfere with the evaluation. * Who had been deprived of their freedom by administrative or legal decision or who is under guardianship. * In a social or sanitary establishment. * Having received 4500 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the present study. * Participating to another research on human beings or who is in an exclusion period of one. * Intensive exposure to sunlight or UV-rays within the previous month and foreseen during the study. * Suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results. * With known history of or suffering from autoimmune disease and/or immune deficiency. * Suffering from inflammatory and/or infectious cutaneous disorders in or near the studied zones (herpes, acne, mycosis, papilloma…). Subject with recurrent herpes is not eligible even if asymptomatic at time of inclusion. * Having history of severe allergy or anaphylactic shock including hypersensitivity to hyaluronic acid or to one of the component of the tested device, antiseptic solution or anaesthesia product if applicable. * With fructose intolerance. * With a past history of streptococcal disease, such as acute rheumatic fever or recurrent sore throats. * Predisposed to keloids or hypertrophic scarring. * Prone to develop inflammatory skin conditions or having tendency to bleeding disorders. * Having received treatment with a laser, a dermabrasion, a surgery, a deep chemical peeling or other ablative procedure on the cheeks or the neckline area within the past 12 months prior to study start. * Having received injection with a resorbable filling product in the cheeks or the neckline area within the past 18 months prior to study start. * Having received at any time injection with a slowly resorbable filling product (polylactic acid, calcium hydroxyapatite, combinations of hyaluronic acid (HA) and hypromellose, HA and dextran microbeads or HA and TriCalcium Phosphate (TCP), …) or with a non-resorbable filling product (polyacrylamide, silicone, combination of methacrylic polymers and collagen, polymer particles, …). * Having received at any time a treatment with tensor threads on the face or the neckline area. * Having started or changed her oral contraceptive or any other hormonal treatment during 12 weeks prior to study start. * Using medication such as aspirin, NSAIDs (ibuprofen, naproxen, …), antiplatelet agents, anticoagulants, vitamin C within one week prior to study start and agreeing not to take such treatments within 1 week prior to the second and third injections or being a chronic user. * Undergoing a topical treatment on the test area or a systemic treatment: * anti-histamines during the 2 weeks prior to study start; * immunosuppressors and/or corticoids during the 4 weeks prior to study start; * retinoids during the 6 months prior to study start.