The Evaluation of Efficacy and Safety of Hyaluronic Acid Injection on Skin Moisturization and Elasticity

This is a prospective, single center, randomized, intra-individual study with blinded evaluators assessing the efficacy and safety of STYLAGE® HydroMax on skin moisturization and elasticity on the cheek and neckline area. Forty seven female subjects will be enrolled and will receive 3 injections of product one month apart on the cheek and neckline area in a randomized fashion with the contralateral non-treated cheek and neckline area. Injection will be performed into the mid to deep dermis of the cheek and neckline area (1 mL per session and per area) by micro-papular injection technique. Subjects will be followed up at 1, 2, 3, 4, 6 and 9 months timepoints. Variation of moisturization, elasticity and roughness of treated areas in comparison with non-treated areas will be measured using Corneometer®, Cutometer®, Dermatop® or Primos Lite® respectively. Global aesthetic improvement, subject satisfaction, pain at injection and safety will also be assessed.

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.