Prospective, Single Site, Controlled Comparative Study to Identify and Assess Tissue Responses After Injection With Various Biostimulatory Products
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Arm 1 - Ultrasound Analyses - Skin Thickness (mm)
研究概览
简要总结
The objective of this study is to identify and assess in vivo tissue responses after injection with various biostimulatory products at various timepoints. The study will also provide tissue specimens which will be used in a subsequent study.
Safety endpoint: incidence of adverse events.
详细描述
The objective of this study is to identify and assess tissue responses after injection with various biostimulatory products that are already used in the market and have CE approval. The study will assess in vivo tissue responses and provide tissue specimens which will be used in a subsequent study, under a separate protocol.
Assessments under this protocol will include ultrasound of in vivo tissue.
Safety endpoint: incidence of adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male & females; 22 to 65 years of age.
- •Voluntary participation
- •Ability to comprehend and provide informed consent.
- •Participants agree NOT to use any topical agents or products that will induce skin peeling or change the appearance of the skin in the treatment area, during the study period.
- •Participants agree NOT to undergo any aesthetic treatments that influence the appearance of the skin in the treatment area during the study period.
- •Participants agree NOT to undergo any surgical treatments in the treatment area during the study period.
- •Participants agree NOT to take part in another clinical study or undergo other treatments during the study period.
排除标准
- •Any previous surgery in the abdominal area.
- •Any previous treatment in the abdominal area.
- •Planning to receive treatment of any kind in the abdominal area.
- •Acute inflammatory process and/or infection at the injection site.
- •Treatment of skin area with dermatosis.
- •Eczema, exanthema or open wounds.
- •Previous application of over the counter or prescription, oral or topical, anti-wrinkle or skin enhancer products on the abdominal skin within the past 3 months unless allowed by the study and is continued throughout the study.
- •Any contraindication to treatment with biostimulatory products based on the product's IFU.
- •Previous pregnancy or intending to become pregnant during study participation.
- •Known hypersensitivity to biostimulatory products or any of their formulation ingredients.
- •Allergic reaction to topical and local anesthetics.
- •Currently using anticoagulant therapy.
- •Haemophilia / bleeding disorder.
- •Chemotherapy, radiotherapy or high doses of corticosteroids.
- •Systemic infection (e.g., hepatitis).
- •Uncontrolled diabetes mellitus.
- •Any medical condition that may put the participant at increased risk with exposure to biostimulatory products.
- •Any medication that might modulate the immune response.
- •Any other illness or condition that, in the opinion of the investigator, would mean that study participation was not in the best interest of the prospective participant.
- •Is a female of childbearing potential and not using medically effective birth control or is pregnant or lactating.
- •Any serious disease or disorder (medical or psychiatric) that could, in the opinion of the investigator, interfere with the safe completion of treatment according to this protocol or with study.
- •Injection of local anesthesia into the flap during abdominoplasty surgery.
研究组 & 干预措施
Arm 2 - Radiesse Classic (1:1 Dilution)
Five participants in Arm 2 will receive Radiesse Classic diluted 1:1 with sterile saline (CaHA-CMC 1:1) and saline control injections at separate predefined abdominal injection sites. All injections will be administered at a single protocol-defined timepoint, 6 months prior to removal of redundant abdominal tissue.
干预措施: Injection (Device)
Arm 2 - Sculptra
Five participants in Arm 2 will receive Sculptra diluted with 5 mL of sterile saline and saline control injections at separate predefined abdominal injection sites. All injections will be administered at a single protocol-defined timepoint, 6 months prior to removal of redundant abdominal tissue.
干预措施: Injection (Device)
Arm 1
Subjects in Arm 1 will receive injections of biostimulatory products (Radiesse(+) undiluted, Radiesse diluted 1:1, Radiesse diluted 1:2, Sculptra, Ellanse, HArmonyCa) at 3 timepoints (six months, three months and two weeks) prior to removal of redundant abdominal tissue.
干预措施: Injection (Device)
结局指标
主要结局
Arm 1 - Ultrasound Analyses - Skin Thickness (mm)
时间窗: 6 months, 3 months and 2 weeks prior to surgery timepoint(s)
Ultrasound of injection site tissue analyses (dermal thickness (mm))
Arm 1 - Ultrasound Analyses - Elastosis
时间窗: 6 months, 3 months and 2 weeks prior to surgery timepoint(s)
Elastosis assessed by ultrasound at the injection site and reported according to the study-defined ultrasound elastosis category/grade.
Arm 1 - Ultrasound Analyses - Microvascular Formation
时间窗: 6 months, 3 months and 2 weeks prior to surgery timepoint(s)
Microvascular formation assessed by ultrasound at the injection site and reported according to the study-defined category/grade.
Arm 2 - Ultrasound Analyses - Skin Thickness (mm)
时间窗: 6 months prior to surgery timepoint(s)
Ultrasound of injection site tissue analyses (dermal thickness (mm))
Arm 2 - Ultrasound Analyses - Elastosis
时间窗: 6 months prior to surgery timepoint(s)
Elastosis assessed by ultrasound at the injection site and reported according to the study-defined ultrasound elastosis category/grade
Arm 2 - Ultrasound Analyses - Microvascular Formation
时间窗: 6 months prior to surgery timepoint(s)
Microvascular formation assessed by ultrasound at injection site and reported according to the study-defined category/grade.
次要结局
未报告次要终点