NCT06195605进行中（未招募）不适用
Investigating Age Dependence of Fibroblast and Extracellular Matrix Responses to Cross-linked Hyaluronic Acid Filler in Human Skin
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Extracellular Matrix (ECM) deposition as measured using histological stain(s) of skin
研究概览
简要总结
The purpose of the study is to investigate the impact of the injection of dermal filler on the quality of the skin dermal extracellular matrix in persons between the ages of 30-50 years. The quality of the dermal extracellular matrix will be assessed following injection of dermal filler compared to injection of saline vehicle.
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
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must understand and sign the informed consent prior to participation
- •Subjects must be in generally good health
- •Subjects must be able and willing to comply with the requirements of the protocol
排除标准
- •Pregnant, plan to become pregnant during the study, or are nursing a child. Participants will be asked to self-report pregnancy
- •Individuals with bleeding disorders
- •Tend to heal poorly or form very thick scars called keloids
- •Have a lidocaine sensitivity, including those with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction.
- •Individuals with active inflammation or infection of the skin, including active herpes infection.
- •Have a significant medical history or concurrent condition which the investigator(s) feel is not safe for study participation, including history of frequent herpes infections, and subjects planning to be exposed to excessive sun, Ultraviolet lamps and extreme cold weather during the first week after injection.
- •History of allergies to gram positive bacterial proteins
- •Individuals with who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks.
- •Have an active inflammation or infection of the skin near the site of injection
- •Are taking any medications that suppress your immune system
- •Have severe allergies to medications or other things that we believe might make participation unsafe for you
- •Have a history of connective tissue diseases, such as:
- •rheumatoid arthritis
- •scleroderma
- •polymyositis/dermatomyositis
- •systemic lupus erythematosus (SLE)
研究组 & 干预措施
Photodamaged skin
Experimental
干预措施: Restylane-L (Device)
Photodamaged skin
Experimental
干预措施: Vehicle (Device)
结局指标
主要结局
Extracellular Matrix (ECM) deposition as measured using histological stain(s) of skin
时间窗: Approximately 4 weeks
Reported as a semi-quantitative grade. The grading scale is 1-4. The higher the number to increased ECM deposition.
次要结局
未报告次要终点
研究者
Gary Fisher
Professor
University of Michigan
研究点 (1)
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