Stretch Mark Treatment Using Subcutaneous Skin Abrasion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Improvement in Striae Distensae Appearance
研究概览
简要总结
The goal of this clinical trial is to learn if a device works to treat striae distensae. It will also learn about the safety of the device. The main questions it aims to answer are:
- Does the device improve the appearance of striae distensae?
- Does the device cause any problems when treating striae distensae? Researchers will compare the appearance of striae distensae before and after treatment with the device.
Participants will:
- Undergo treatment with the device in the clinic
- Visit the clinic 1 week, 3 months, and 1 year for checkups and tests
详细描述
Participants will have the area of striae distensae anesthetized with local anesthetic. A biopsy will be performed and a device will be placed underneath the skin that will abrade the skin. Three months later another biopsy will be performed, photographs will be taken, and participants will fill out surveys to determine the effectiveness of the device to improve the appearance of the striae distensae.
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
- 否
入选标准
- •Striae distensae
排除标准
- •coagulation deficiency
研究组 & 干预措施
Striae Distensae Treatment
Striae Distensae Treatment With A Device
干预措施: Striae Distensae Treatment Device (Device)
结局指标
主要结局
Improvement in Striae Distensae Appearance
时间窗: From enrollment to 12 months after treatment
Comparison of photographs before and after treatment
次要结局
未报告次要终点
研究者
Arin Greene
Professor of Surgery
Boston Children's Hospital