Comparison of the Efficacy Between Cryolipolysis Versus Cryolipolysis Plus Subcision For Treatment of Cellulite: A Prospective Randomized Control Trial
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
- 2
- 主要终点
- Live rating by a blinded dermatologist using cellulite severity scale
研究概览
简要总结
This is a prospective randomized controlled study comparing the efficacy of cryolipolysis versus a combination of cryolipolysis and surgical subcision for the treatment of cellulite. The treatment sites are both outer thighs. One outer thigh will be randomized to receive one treatment of cryolipolysis, while the contralateral thigh will be assigned to receive the combination cryolipolysis plus surgical subcision. A live rating by a blinded dermatologist will evaluate the treatment and control areas using a cellulite severity scale at week 0 (before treatment) and at the 3-month follow up visit.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female subjects 18-65 years of age with at least a 5 on the CSS scale on both outer thighs.
- •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
- •Subjects who are 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 hemoglobulinuria, cold urticaria.
- •Subjects who have active skin disease or skin infection in the treatment area.
- •Subjects who are allergic to lidocaine or prilocaine.
- •Subjects who are allergic to both cephalexin (or penicillin) AND levofloxacin (or another quinolone antibiotic).
- •Subjects who have history of abnormal scarring.
研究组 & 干预措施
cryolipolysis plus subcision
干预措施: cyrolipolysis (CoolSculpting device) (Procedure)
cryolipolysis plus subcision
干预措施: subcision (Procedure)
cyrolipolysis
干预措施: cyrolipolysis (CoolSculpting device) (Procedure)
结局指标
主要结局
Live rating by a blinded dermatologist using cellulite severity scale
时间窗: Change from Baseline in cellulite severity scale at 3 months
The cellulite severity scale rates cellulite 1-5 as mild, 6-10 as moderate, and 11-15 as severe.
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
Northwestern University