NCT03529292已完成不适用
Pilot Study to Evaluate the Safety and the Efficacy of the Filling Using the Matrix and Cells, Obtained by the AmeaCell® Device From Autologous Adipose Tissue and Intended for the Filling of Wrinkles on the Face.
Symbioken1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2018年7月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Local tolerance
研究概览
简要总结
The purpose of this study is to evaluate the filling using the Matrix and Cells, obtained by the Ameacell® device from autologous adipose tissue and intended for the filling of wrinkles on the face.
详细描述
The purpose of this study is to evaluate the filling using the Matrix and Cells, obtained by the Ameacell® device from autologous adipose tissue and intended for the filling of wrinkles on the face.
This is a mono-center, pilot study in 24 subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Man or woman from 18 to 70 years
- •Subject wishing liposuction
- •Subject wishing a filling of facial wrinkles for aesthetic purposes
- •Subject for which it is possible to achieve a puncture of adipose tissue of at least 150ml so that after decantation or centrifugation there remains 100ml of adipose tissue
- •Facial wrinkles that can be treated with the Matrix and Cells volume of approximately 12ml
- •Grade of wrinkles at level 2 minimum of the nasolabial fold according to the WSRS scale
- •Free, informed and written consent
- •Affiliate or beneficiary of a social security scheme
排除标准
- •Pregnant or breastfeeding woman or planning to be pregnant
- •Woman of childbearing age without effective contraceptive
- •Subject having a filling of facial wrinkles with hyaluronic acid or by a method of lipofilling (injection of adipose tissue) in the 12 months prior to the enrollment
- •Subject who has undergone treatment of facial wrinkles by injection of botulinum toxin, by mesotherapy or cosmetic procedure (laser, photo modulation, intense pulsed light, radio frequency, dermabrasion, chemical peel or other ablative procedures) within 12 months at least prior to enrolment or subject who is planning this type of procedure during the study
- •Subject who has received semi-permanent dermal fillers or permanent facial implants or who is planning to do this type of implant during the study
- •Subject having history of formation of hypertrophic scars or keloids
- •Subject having a skin disease or skin inflammation (e.g. acne, herpes, eczema, psoriasis, sclerosis) at the site to be treated or elsewhere on the body if suspected of spreading on the site to be treated
- •Subject with allergic contact dermatitis or a history of allergic contact dermatitis or a family history of allergic contact dermatitis
- •Presence of tattoo and / or scar in the treatment area that, in the opinion of the investigator, could interfere with the evaluation of the study
- •Diabetes (type I or type II)
- •Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) seropositivity
- •Subject under anti-HIV treatment
- •Autoimmune disease
- •Immunodepression
- •History of phlebitis or pulmonary embolism
- •Major pathology involving the renal, hepatic, cardiovascular, immune and / or nervous system
- •Cancerous lesion on the face
- •Any other diseases that could, in the opinion of the investigator, be clinically significant and make the subject inappropriate for the study, alter the results of the study or increase the risk for the subject
- •Known hypersensitivity to cobalt
- •Known hypersensitivity to collagenase
- •Known or suspected allergy to lidocaine or any other amide anesthetic
- •History of known severe allergies (anaphylaxis, angioedema) for a product used in the study
- •Any contraindication to lipofilling surgery
- •Active smoking or subject who stopped smoking less than one month before the intervention
- •Radiotherapy treatment at the head and neck region.
- •Chemotherapy treatment
- •Treatment with anticoagulant or Nonsteroidal anti-inflammatory drug (NSAID) or any other substance known to increase clotting time during the 2 weeks prior to enrollment
- •Corticosteroids in the 6 weeks prior to enrollment
- •Subject having a metal-metal hip prosthesis
- •Subject under lidocaine or structurally related local anesthetic (e.g. bupivacaine) within 24 hours prior to enrollment
- •Subject having undergone general anesthesia for less than 8 days
- •Treatment with an oral or topical retinoid in the month prior to enrollment
- •Subject having a history of drug or alcohol addiction in the 12 months prior to enrollment
- •Participation in another research including an exclusion period still in progress at the time of enrollment
- •Person placed under guardianship or curatorship or under the protection of justice
结局指标
主要结局
Local tolerance
时间窗: First 4 weeks after the injection
The subject will record daily the local tolerance in a diary card. Signs of erythema, edema, bruising, discolouration, pain / tenderness, and pruritus will be noted and scored from 0 (none) to 3 (severe).
Incidence of the Adverse Event(s)
时间窗: From selection up to 12 months after the injection
Adverse events will be investigated and recorded at each visit by the investigator
次要结局
- Depth of the wrinkles by 3D picture(Change from baseline at month 1, 6 and 12)
- Wrinkle Severity Rating Scale (WSRS) Evaluation for the nasolabial folds(Change from baseline at month 1, 6 and 12)
- Global Aesthetic Improvement Scale (GAIS) Evaluation(Change from baseline at month 1, 6 and 12)
研究者
研究点 (1)
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