Pilot Study for the Clinical Evaluation of Mechanical Coring to Achieve Directional Skin Tightening
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 6
- 主要终点
- Percentage of Cores Successfully Removed by Coring Device
研究概览
简要总结
The objective of this clinical study is to evaluate the safety and efficacy of mechanical coring for directional skin tightening. This study is a prospective, up to 3 center, multiple skin treatment area study of the safety and efficacy of mechanical coring with directional closure to achieve directional skin tightening.
详细描述
The study will evaluate the progress of up to 70 subjects after one treatment at up to 6 treatment areas on the body chosen from 2 on the neck (each treatment area approximately 1x3 cm), 2 on each underarm, 1 on each cheek, 2 on the abdomen, one on each thigh and 2 on the forehead area above the eyebrows (all approximately 6x4 cm). Subjects will be followed at 2, 5, 14, 28, 60, and 90 days after treatment.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, male or female subjects between 30 and 70 years of age.
- •Able to read, understand, and voluntarily provide written Informed Consent.
- •Able and willing to comply with the treatment/follow-up schedule and requirements.
- •Women of childbearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study and have a negative Urine Pregnancy test at baseline.
- •Subjects may have any Fitzpatrick skin type, however, no more than 35% of subjects may have Fitzpatrick skin type V or VI.
排除标准
- •Previous aesthetic (device and/or surgical) skin treatment in the treated areas (under arms and/or behind the ear) in the previous 6 months.
- •Fat, collagen, silicone, tattoos, body jewelry, that cannot be removed for the duration of treatment, and tegaderm/glue application or any other synthetic material in the treatment area.
- •History of keloid formation
- •Active smoker or having quit smoking in the last 3 months.
- •Active, chronic, or recurrent infection
- •Compromised immune and/or healing system (e.g. diabetes)
- •Hypersensitivity/allergy to analgesic agents, Betadine, tumescent, Benzoin Tincture, Tegaderm or tensioning tape that will be used in the study.
- •Co-morbid condition that could limit the ability to participate in the study or to comply with follow-up requirements.
- •Pregnant or breastfeeding
- •Any indication that may cause excessive bleeding, e.g., anticoagulants.
- •Carcinoma, melanoma, or any other cancerous condition in the last 6 months.
- •Allergy to adrenaline, epinephrine, or Tranexamic acid (TXA).
- •Currently or in the last 1-month part of another clinical study of an investigational drug and/or experimental medical device
- •Any issue that, at the discretion of the investigator would contra-indicate the subject's participation.
结局指标
主要结局
Percentage of Cores Successfully Removed by Coring Device
时间窗: 1 day
Percentage of cores successfully removed by the coring device without manual removal.
次要结局
- Downtime, as evaluated using the Subject Questionnaire(Up to Day 90 (end of study))