NCT00974415已完成不适用
A Pilot Study of the Carbon Dioxide Treatment for Fat Reduction
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Reduction of flank circumference
研究概览
简要总结
The primary objective of this study is to demonstrate the efficacy and safety of the carbon dioxide for subcutaneous fat reduction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject ages ≥ 18 years old
- •Body mass index (BMI) between 18.5-24.
- •(BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches).
- •Subject in good health
- •Willing and able to abstain from partaking in any treatment other than the study procedure (existing or new) to promote body contouring and/or weight loss during the course of study participation.
- •Subject agrees to maintain their weight (i.e. within 5 pounds) by not making any changes to diet or lifestyle during the study.
- •The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator
排除标准
- •Pregnant or lactating or intends to become pregnant in the next 9 months.
- •Unable to understand the protocol or to give informed consent
- •Any previous and/or pending procedures at the treatment area or that may likely affect the treatment area
- •Pending and/or anticipated major change in diet or exercise pattern in the six weeks following the last treatment or who has taken diet pills within the last 6 months.
- •History of asthma or chronic obstructive pulmonary diseases
- •Active skin disease or skin infection in the treatment area
- •Bleeding tendency or coagulopathy
- •Subject who are allergic to lidocaine
- •Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical study, or would pose as an unacceptable risk to the subject
研究组 & 干预措施
treatment
Experimental
CO2 treatment
干预措施: CO2 (Procedure)
sham
Sham Comparator
sham treatment
干预措施: Sham (Procedure)
结局指标
主要结局
Reduction of flank circumference
时间窗: 6 months
次要结局
- 10-point pain visual analog scale(4 weeks)
- Patient satisfaction, determined by using patient satisfaction questionnaires.(6 months)
- Any adverse events(6 months)
研究者
Murad Alam
Professor of Dermatology
Northwestern University
研究点 (2)
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