Effectiveness and Safety of STYLAGE® L Lidocaïne in the Treatment of Nasolabial Folds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Mean change in nasolabial fold severity assessed in live
研究概览
简要总结
STYLAGE® L Lidocaine is a CE-marked hyaluronic acid gel intended to fill skin depressions on the face by dermal injection. In this study, 50 healthy subjects between the age of 30 and 65, with moderate to severe nasolabial folds as assessed in live, who have given their informed consent and met all eligibility criteria, will be enrolled. Subjects will randomly receive injection of STYLAGE® L Lidocaine on one nasolabial fold and injection of an active comparator on the other nasolabial fold. A touch-up is possible if required one month after. Subjects will come to a total of 7 visits over a period of 12 months. Variation in severity score of nasolabial folds will be assessed in live and on photographs by independent evaluators. Variation in nasolabial fold depth, global aesthetic improvement, subject satisfaction, pain at injection site and safety will also be assessed.
详细描述
This is a prospective, multicenter, randomized, controlled versus active treatment, within-subjects study with blinded subjects and evaluators assessing the efficay and safety of STYLAGE® L Lidocaine in the treatment of nasolabial folds. Fifty healthy subjects between the age of 30 and 65, with moderate to severe nasolabial folds attaining either grade 3 on both sides or grade 4 on both sides on the Wrinkle Severity Rating Scale (WSRS) for nasolabial folds as assessed in live, who have given their informed consent and met all eligibility criteria, will be enrolled. Subjects will randomly receive dermal injections consisting in a maximum of 2 mL of STYLAGE® L Lidocaine on one nasolabial fold and a maximum of 2 mL of an active comparator on the other nasolabial fold. A touch-up consisting in the dermal injection of maximum 1 mL of product per nasolabial fold is possible if required one month after. Subjects will be followed up at 1, 3, 6, 9 and 12 months timepoints. Variation in severity score of nasolabial folds will be assessed in live and on photographs by independent blinded evaluators using the validated 5-point Wrinkles Severity Rating Scale (WSRS). Global aesthetic improvement will be assessed using the Global Aesthetic Improvement Scale (GAIS). Variation in nasolabial fold depth will be assessed using Dermatop®. Subject satisfaction, pain at injection site and safety will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Injectors will be unblinded. All subjects, investigators (in charge of clinical examination, assessment of local tolerance, live and on photograph assessment of nasolabial folds severity), as well as technicians (in charge of photographs and measurement of roughness) will be blinded.
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subject.
- •Sex: female or male.
- •Age: between 30 and 65 years.
- •Subject having given freely and expressly his/her informed consent and data privacy consent.
- •Subject with approximate symmetry, moderate to severe Nasolabial Folds (NLFs) attaining either grade 3 on both sides or grade 4 on both sides on the Wrinkle Severity Rating Scale (WSRS) for NLF, as assessed in live.
- •Subject with marionette's lines that do not require to be treated according to investigator.
- •Subject willing to have photographs of the face taken.
- •Subject, psychologically able to understand the study related information and to give a written informed consent.
- •Subject agreeing not to receive another aesthetic procedure on the face (e.g., laser, dermabrasion, surgery, deep chemical peeling, surface peel, tensor threads, injection with a filling product) during the whole study.
- •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 screening visit and during the whole study.
排除标准
- •Pregnant or breastfeeding woman or planning a pregnancy during the study.
- •Subject with a tattoo, a scar, moles or anything on the studied zones 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.
- •For France only: subject having received 4500 euros indemnities for participation in researches involving human beings in France in the 12 previous months, including participation in the present study.
- •Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results.
- •Subject suffering from untreated epilepsy.
- •Subject with known history of or suffering from autoimmune disease and/or immune deficiency.
- •Subject with a past history of streptococcal disease, such as acute rheumatic fever or recurrent sore throats and in case of acute rheumatic fever with heart complications.
- •Subjects suffering from porphyria.
- •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 screening visit.
- •Subject having history of allergy or anaphylactic shock including hypersensitivity to hyaluronic acid, to gram positive bacterial proteins, to lidocaine, to one of the components of the tested devices or antiseptic solution or amide-type local anaesthetics.
- •Subject having history of severe and/or evolutive / unstable / recent allergy.
- •Subject predisposed to develop keloids or hypertrophic scarring.
- •Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders.
- •Subjects with known cardiac conduction disorders.
- •Subject having received treatment with a laser, a dermabrasion, a surgery, a deep chemical peeling or other ablative procedure below the inferior orbital rim within the past 12 months prior to screening visit.
- •Subject having received treatment with a surface peel below the inferior orbital rim within the past 6 months prior to screening visit.
- •Subject having received injection with a resorbable filling product (eg, hyaluronic acid, collagen) below the inferior orbital rim within the past 12 months prior to screening visit.
- •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 permanent filling product (polyacrylamide, silicone, combination of methacrylic polymers and collagen, polymer particles, ...).
- •Subject having received at any time a treatment with tensor threads below the inferior orbital rim.
- •Subject who received oral surgery (e.g. tooth extraction, orthodontia or implantation) within 6 weeks prior to screening visit or who plans to undergo any of these procedures during the study.
- •Subject having started or changed her oral contraceptive or any other hormonal treatment during 12 weeks prior to screening visit.
- •Subject using medication such as aspirin, nonsteroidal anti-inflammatory drugs (NSAID) (ibuprofène, naproxène, ...), antiplatelet agents, anticoagulants, vitamin C or other substances known to prolong bleeding time (warfarin, , herbal supplements with garlic or ginkgo biloba, ...) within 1 week prior to injection visit (V1) and agreeing not to take such treatments within 1 week prior to touch-up visit, or being a chronic user.
- •Subject using medication that reduce or inhibit hepatic metabolism (cimetidine, beta-blockers, etc).
- •Total injection volume of cross-linked hyaluronic acid >14 mL within 1 year prior to screening visit.
- •Subject undergoing a topical treatment on the test area or a systemic treatment:
- •Anti-histamines during the 2 weeks prior to injection visit (V1) and agreeing not to take such treatment within 2 weeks prior to touch-up visit;
- •Immunosuppressors and/or corticoids during the 4 weeks prior to screening visit;
- •Retinoids during the 6 months prior to screening visit.
结局指标
主要结局
Mean change in nasolabial fold severity assessed in live
时间窗: Month 6
Mean change in nasolabial fold severity from baseline to 6 months after treatment initiation, as assessed by an independent blinded live evaluator using the validated 5-point Wrinkles Severity Rating Scale (WSRS). The Wrinkles Severity Rating Scale is a 5-grade scale (from grade 1 to grade 5) with minimum grade representing a better outcome. Grade 1 corresponds to "Absent", grade 2 to "Mild", grade 3 to "Moderate", grade 4 to "Severe" and grade 5 to "Extreme".
次要结局
- Evaluation of subject's satisfaction(Month 1, Month 3, Month 6, Month 9, Month 12)
- Evaluation of pain during injection(Day 0, Month 1)
- Mean change in nasolabial fold severity assessed in live(Month 1, Month 3, Month 9, Month 12)
- Evaluation of global aesthetic improvement(Month 1, Month 3, Month 6, Month 9, Month 12)
- Evaluation of GAIS responder rate(Month 1, Month 3, Month 6, Month 9, Month 12)
- Evaluation of WSRS responder rate(Month 1, Month 3, Month 6, Month 9, Month 12)
- Mean change in nasolabial fold depth(Month 1, Month 3, Month 6, Month 9, Month 12)
- Mean change in nasolabial fold severity assessed on photographs(Month 1, Month 3, Month 6, Month 9, Month 12)
- Report of adverse events(Up to Month 12)