NCT06454994已完成不适用
A Prospective, Multicentric, Comparative, Split-face Clinical Study to Evaluate Safety and Effectiveness of Noble Lift® Lifting Threads
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- GCS Co., Ltd
- 入组人数
- 65
- 试验地点
- 4
- 主要终点
- Comparison of Global Aesthetic Improvement (GAIS) by the investigator between both products
研究概览
简要总结
The aim of this study is to compare two models of the Nobel Lift range (PDO sutures) with similar PDO devices available on the market, in a split-face comparative study. Each thread model will be used in one indication: upper face (eyebrow lift) or mid-face and lower-face.
Aesthetic efficacy of the devices will be evaluated and compared with the Global Aesthetic Improvement Scale (GAIS), jowl laxity scale, subjective evaluation of the patient and photographs during a 12-months period. Safety of the devices and procedures will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI comprised between 18.5 and 30
- •No ongoing or planned diet.
- •Group 1: requiring an aesthetic treatment of upper face with resorbable threads.
- •Group 2: Subject requiring an aesthetic treatment of mid-face and lower-face with resorbable threads
- •Subject with dense and not too thin skin.
排除标准
- •Pregnant or nursing woman or planning a pregnancy during the study;
- •Suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study result and/or subject safety, especially cardiac disorder, non-controlled high blood pressure, diabetes, panic disorders, depression, active auto-immune disease, cold, high fever,…
- •Suffering from malnutrition.
- •Acute inflammatory process or infection, or history of chronic or recurrent infection or inflammation with the potential to interfere with the study results or increase the risk of adverse events.
- •Wound healing disorder or with a disorder that may impact wound healing such as connective tissue or immunosuppressive disorder.
- •History of precancerous lesions/skin malignancies.
- •Active skin disease within 6 months of study entry.
- •Scars, rosacea, herpes, acne, blotches or other pathology in the face, at the investigator appreciation.
- •Predisposed to keloidosis or hypertrophic scarring.
- •Known history of hyper- or hypo-pigmentation in the face.
- •Known history of multiple allergies, allergic/anaphylactic reactions including allergy/ hypersensitivity to lidocaine, anaesthetics of the amide type, the used antiseptic components, the used antibiotic cream components.
- •Known bleeding disorder or is receiving medication that will likely increase the risk of bleeding during treatment.
- •Extensive skin laxity, thin skin and/or severe malar fat sagging.
- •Foreign body sensitivity or known or suspected allergies to implant or instrument materials in particular plastic/biomaterial.
- •Any medication which may interfere, at the interpretation of the investigator, with the study objectives in term of efficacy and safety/tolerance.
- •Dental care in the past 2 weeks or who planned to receive dental care in the 2 months after the treatment.
- •Anticoagulant (such as aspirin, warfarin, blood circulation enhancer and clotbuster) during the week before the injection session .
- •Chemotherapy agents, immunosuppressive medications or systemic corticosteroids in the past 3 months and during the study.
- •Lifting of the face in the past 12 months or other surgery of the face in the past 6 months.
- •Resorbable fillers within the past 12 months, other resorbable threads within the past 12 months, neurotoxin in the past 5 months or plans to receive such treatments during the study.
- •Permanent filler on the face.
- •Subcutaneous permanent retaining structure on the face (meshing, permanent threads, gold strand etc.).
- •Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen during the study.
研究组 & 干预措施
Noble Lift threads
Experimental
干预措施: Eyebrow lift (Device)
Noble Lift threads
Experimental
干预措施: Jaw lift (Device)
Croquis threads
Active Comparator
干预措施: Eyebrow lift (Device)
Croquis threads
Active Comparator
干预措施: Jaw lift (Device)
结局指标
主要结局
Comparison of Global Aesthetic Improvement (GAIS) by the investigator between both products
时间窗: Month 3
Non-inferiority of Noble Lift® threads in comparison with Croquis® thread, in terms of GAIS mean score on Month 3, assessed by an independent blinded investigator on photos (in global and for each indication). GAIS is a scale from 1 (worse) to 5 (very much improved).
次要结局
- Percentages of responders for Global Aesthetic Improvement (GAIS) by the investigator(Month 3, Month 6, Month 12)
- Percentages of responders for Global Aesthetic Improvement (GAIS) by the subject(Month 3, Month 6, Month 12)
- Percentages of subjects satisfied with the intervention using a subjective evaluation questionnaire(Month 3, Month 6, Month 12)
- Number and percentages of skin reactions scored by the investigator(Month1, Month 3, Month 6, Month 12)
- Change from baseline of Facial Laxity Rating Scale (FLRS) score(Month 3, Month 6, Month 12)
- Number and percentages of Adverse Events(Month1, Month 3, Month 6, Month 12)
- Number and percentages of immediate and early skin reactions collected by the subject(Month 1)
研究者
研究点 (4)
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