The Evaluation of Efficacy and Safety of Stylage® XL Lidocaïne for the Restoration and/or Augmentation of Facial Volume

This is a prospective, uncontrolled, single site study with a blinded evaluator assessing the efficacy of Stylage® XL Lidocaïne on FVLS and GAIS clinical scoring.

The study duration by subject is 18 months with a screening visit (V0) before injection, the baseline visit (injection of Stylage® XL Lidocaïne, V1) and 5 follow-up visits after 1, 3, 6, 12 and 18 months (V2 to V6). At 1 month (V2) an optional touch-up may be done (if needed).

The primary endpoint is the facial volume variation from baseline (D0) to 6 months after treatment initiation measured by an independent evaluator on photographs using FVLS (Facial Volume Loss Scale).

Facial volume variation (evaluated by an independent evaluator) & treatment responder rate, Global Aesthetic Improvement (evaluated by the patient and the doctor), volume on the cheekbones and chin & chin angle (for applicable subjects), subject's satisfaction will be measured at all time-point with a FVLS, GAIS,3D QuantifiCare system, FACE-Q questionnaire (cheekbones and chin) respectively. Safety will be also assessed.

Inclusion criteria

• Healthy Subject;
• Sex: male or female;
• Age: between 30 and 65 years;
• Subject having given freely and expressly his informed consent;
• Subject requiring injection on the cheekbones (upper part of the cheek);
• Subject with grade from 3 to 5 on the Facial Volume Loss Scale (FVLS);
• Subject, psychologically able to understand the study related information and to give a written informed consent;
• Subject 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;
• Subject agreeing to keep their usual cleansing / care products during the whole study period;
• Subject agreeing to apply a Sun Protection Factor (SPF) 50 cream during non-intensive exposure to sunlight.

Exclusion criteria

In terms of population

• Pregnant or nursing woman or planning a pregnancy during the study;
• Subject with a scar, moles or anything on the face which might interfere with the evaluation;
• Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship;
• Subject in a social or sanitary establishment;
• Subject participating to another research on human beings or who is in an exclusion period of one;
• Subject having received 4500 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the present study.
• Intensive exposure to sunlight or Ultraviolet-rays (UV-rays) within the month before each visit;

In terms of associated pathology

• Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results;
• Subject with known history of or suffering from autoimmune disease and/or immune deficiency;
• Subject 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;
• Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders
• Subject having history of allergy or anaphylactic shock including hypersensitivity to hyaluronic acid or to one of the components of the tested device;
• Subject having history of allergy or anaphylactic shock including hypersensitivity to amide-type local anaesthetics or antiseptic solution;
• Subject with a past history of streptococcal disease, such as acute rheumatic fever or recurrent sore throats;
• Subject with a tendency to develop keloids or hypertrophic scars;
• Subject with haemostatic disorder;
• Subject with porphyria;

Relating to previous or ongoing treatment

• Subject having received treatment with a laser, a dermabrasion, a surgery, a deep chemical peeling or other ablative procedure on the face within the past 12 months prior to inclusion;
• Subject having received injection with a resorbable filling product in the face area within the past 18 months prior to inclusion;
• Subject 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, …);
• Subject having received at any time a treatment with tensor threads on the face;
• Subject having started or changed her oral contraceptive or any other hormonal treatment during 12 weeks prior to inclusion;
• Subject under medications that reduce or inhibit hepatic metabolism;
• Subject under medications which may cause lipo-atrophy;
• Subject using medication such as aspirin, NSAIDs (ibuprofen, naproxen, …), antiplatelet agents, anticoagulants, vitamin C within one week prior to inclusion and agreeing not to take such treatments within 1 week prior to visit 2 (M1) or being a chronic user;
• Subject 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.