A Multicenter, Prospective, Randomized Controlled Clinical Study of STYLAGE® XXL Versus No-Treatment for Volume Deficiency in the Mid-face
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Mid-Face Volumetric change
研究概览
简要总结
The primary objective of the study is to demonstrate the superiority of STYLAGE® XXL versus no treatment at 24 weeks after baseline for the creation or restoration of volume deficit in the mid-face.
详细描述
This is a multicenter, prospective, randomized, no-treatment controlled post-market clinical follow-up of a class III medical device. This study is designed to evaluate the safety and effectiveness of STYLAGE® XXL in the restorationor creation of volume in the mid-face.
The objective of this study is to demonstrate the superiority of STYLAGE® XXL versus no treatment at 24 weeks after baseline for the creation or restoration of volume deficit in the mid-face.
Assessment of superiority will be based on 3D analysis of the volumetric change, using a validated imaging system.
Effectiveness of STYLAGE® XXL will be demonstrated if the mean volumetric change at 24 weeks after baseline from pre-treatment in the treatment group is statistically superior to the mean change in the delayed treatment (control) group.
In total, approximately 90 subjects will be enrolled across three study centers in Switzerland, Austria, and France.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The primary endpoint is assessed through objective measures of facial volume, obtained using standardized, three-dimensional (3D), digital photographic images. Measurement will be made by an independent expert who will be blinded, as image files will not reveal subject treatment randomization, or the time point at which the image was taken.
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
- •Aged between 30 and 65 years
- •Seeking correction of his/her mid-face volume deficit, and agrees with recommendation by the Investigator
- •Accept the obligation not to receive any other facial procedures or treatments impacting facial volume augmentation at any time during the study
- •Able to follow study instructions and likely to complete all required visits, as assessed by the Investigator
- •Psychologically able to understand the study related information and to give a written informed consent
- •Have voluntarily provided written informed consent to participate in the study, and use of data privacy (sign the ethics committee approved Informed Consent Form), prior to any study-related procedure being performed
- •Female of childbearing potential (sexually active, not sterile, nor postmenopausal for at least 1 year) must have a negative urine pregnancy test (UPT) at Visit 1 (or Visit 1b), and use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study and for the duration of the study
- •Affiliated to a health social security system (for France only)
排除标准
- •In terms of population:
- •Pregnant or breastfeeding woman, or planning a pregnancy during the study
- •Scars, moles, tattoo, 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 (for France only)
- •In terms of associated pathology:
- •Subject presenting any symptom which can be related to a medical condition that is likely to make the subject not being compliant with the study schedule, at the discretion of the investigator
- •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 active inflammatory and/or infectious cutaneous disorders in or near the studied zones (e.g. herpes, acne). Subject with recurrent herpes in the Midface area 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 with a history of streptococcal disease, such as acute rheumatic fever or recurrent sore throats with cardiac localisation
- •Subject with a tendency to develop keloids or hypertrophic scars
- •Relating to previous or ongoing treatment:
- •Subject having received treatment with a laser, a dermabrasion, a surgery, a peeling, or other ablative procedure on the Midface area within the past 12 months prior to inclusion
- •Subject having received injection with a resorbable filling product in the Midface area within the past 18 months prior to inclusion
- •Subject having received at any time injection with a slowly resorbable filling product (e.g. polylactic acid, calcium hydroxyapatite, combinations of HA and Hypromellose) or with a non-resorbable filling product (e.g. polyacrylamide or silicone)
- •Subject having received at any time a treatment with tensor threads in the Midface area
- •Subject under medications which may cause lipo-atrophy
- •Subject using medication such as aspirin, NSAIDs (e.g. ibuprofen), antiplatelet agents, anticoagulants, vitamin C within one week prior to inclusion and not agreeing not to take such treatments within 1 week prior to visit 2 (M1) or being a chronic user of anticoagulant treatment
- •Subject undergoing a topical treatment on the test area or a systemic treatment:
- •Antihistamines 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
结局指标
主要结局
Mid-Face Volumetric change
时间窗: 24 weeks after baseline
Mean volumetric change between the treatment group and no-treatment control group at 24 (V4) weeks after baseline (V1)
次要结局
- Global Aesthetic Improvement, by the Subjects(4, 12, 24, 48, and 72 weeks after initial treatment)
- Global Aesthetic Improvement, by the Investigators(4, 12, 24, 48, and 72 weeks after initial treatment)
- FACE-Q, by the Subjects(Initial treatment, and 4, 12, 24, 48, and 72 weeks after initial treatment)
- Wrinkle Severity Rating Scale (WSRS), by the Investigators.(4, 12, 24, 48, and 72 weeks after initial treatment)
- Mid-Face Volumetric change(4, 12, 24, 48, and 72 weeks after initial treatment)
- Ease of sculpting and massaging, by the Investigators(Initial treatment, and 4, and 72 weeks after initial treatment)