Comparison of the Efficacy Between Cryolipolysis Versus ATX-101 (Deoxycholic Acid) for the Treatment of Upper Back Fat: a Prospective Randomized Controlled Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in fat measurements from baseline to Day 90.
研究概览
简要总结
This is a prospective randomized controlled study comparing the efficacy of cryolipolysis versus ATX-101 (deoxycholic acid) for the treatment of upper back fat. Participants currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment. The treatment sites are the right and left upper back fat areas. The right and left sides of the upper back fat will be randomly assigned (1:1) to receive cryolipolysis, while the contralateral side will receive ATX-101.
This study was a pilot study designed to determine feasibility of this procedure.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females ≥ 18 years old
- •Subjects are in good health as judged by the investigator.
- •Subjects with mild to moderate upper back fat.
- •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
- •History of hypertrophic scars or keloids
- •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.
- •Pregnant or breast feeding
- •Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
- •Subjects who are unable to understand the protocol or give informed consent.
研究组 & 干预措施
Cyrolipolysis
干预措施: CoolCurve (Device)
Deoxycholic Acid
干预措施: ATX-101 (Drug)
结局指标
主要结局
Change in fat measurements from baseline to Day 90.
时间窗: Baseline and Day 90
Subcutaneous fat measurement will be performed using an ultrasound.
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