Comparison of the Efficacy Between Cryolipolysis and Subcision for Treatment of Cellulite: A Prospective Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Blinded Rating of the Treatment Area (Cryolipolysis vs. Subcision) With the Best Cosmetic Appearance.
研究概览
简要总结
This study intended to investigate and compare the changes that may occur in response to cryolipolysis (localized cool exposure) and subcision (surgical technique) on cellulite. The cryolipolysis cooling device used is FDA approved for skin cooling, but still investigational in the treatment of cellulite. It has previously been used for fat reduction on love handles or back fat. During cryolipolysis, the system drew fat tissue into an applicator then exposes the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite. Subcision is a process used to treat scars left behind by acne or other skin diseases and has been noted to improve moderate to severe cellulite. Subcision is a simple surgical procedure that is performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle is moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together. This study was a pilot study designed to determine feasibility of these procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy female patients 18-60 years of age with more than one evident depressed lesion of cellulite on the upper thighs and/or buttocks.
- •All subjects must have the affected areas that show the mattress phenomenon spontaneously when standing or while both lying and standing (Stage 2 or 3 of Nurnberger-Muller grading scale of cellulite7).
- •Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.
排除标准
- •Pregnant or lactating
- •Subjects who are unable to understand the protocol or to give informed consent.
- •Subjects currently under treatment with an antiplatelet or anticoagulant for any medical problem or patients who have coagulation disorder.
- •Subjects who have a known history of cold-induced disease such as cryoglobulinemia, paroxysmal cold hemoglobinuria, or cold urticaria.
- •Subjects who have active skin disease or skin infection in treatment area.
- •Subjects who are allergic to lidocaine or prilocaine.
- •Subjects who are allergic to both cephalexin (and penicillin) AND levofloxacin (or another quinolone antibiotic).
- •Subjects who have history of abnormal scarring.
结局指标
主要结局
Blinded Rating of the Treatment Area (Cryolipolysis vs. Subcision) With the Best Cosmetic Appearance.
时间窗: 12 weeks
Two dermatologists blindly evaluated and compared the treated and control areas of each side at the final follow up visit (week 12). They rated the area with the best cosmetic appearance and reported the percentages of participants for whom "Cryolipolysis" or "Subcision" resulted in the "best cosmetic appearance". It was possible for raters to determine that neither treatment outperformed the other, thereby rating the control arm better.
次要结局
未报告次要终点
研究者
Murad Alam
Professor in Dermatology, Otolaryngology - Head and Neck Surgery and Surgery-Organ Transplantation
Northwestern University