Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Measurement of changes in sweat production using gravimetric method
研究概览
简要总结
Hyperhidrosis is a condition in which sweating is in excess of that required for normal regulation of body temperature. Commonly affected areas in primary hyperhidrosis include axillae, palms and soles. Secondary hyperhidrosis can affect scalp, face, neck, back, groin and legs. Hyperhidrosis can negatively impact, employment, relationships, or other aspects of quality of life.
The investigators propose to investigate the use of a unique image-guided laser to specifically ablate eccrine sweat glands.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects of ages between 18 and 65 years.
- •Subjects with any Fitzpatrick skin type.
- •Subjects who are proficient in the English language.
- •Willingness to participate in the study.
- •Willingness to undergo experimental procedure.
- •Informed consent agreement signed by the subject.
- •Willingness to follow the follow-up schedule.
- •Willingness not to use any other hyperhidrosis treatment to the tests sites during the study period (i.e. deodorant, at-home iontophoresis, Botox, MiraDry).
- •Patient rates symptoms at level "3" or "4" on the hyperhidrosis disease severity scale (HDSS, see below).
- •Subject in appropriate physical health to ride a stationary bicycle to the point of eliciting sweat.
- •No known allergy to iodine or potato starch
排除标准
- •Subjects on systemic treatment for hyperhidrosis, such as anticholinergic drugs (e.g. glycopyrrolate), sedatives or tranquilizers, within the past 8 weeks.
- •Subjects who have undergone surgical excision of sweat glands or sympathectomy for hyperhidrosis.
- •Subjects with an underlying disorder, such as neurologic injury or disease affecting the autonomic system, vascular disorders and metabolic disorders (e.g. hyperthyroidism, diabetes mellitus) that can produce hyperhidrosis
- •Subjects with a history of coronary artery disease.
- •Subjects with a history of poor compliance or psychosis
- •Subjects taking SSRIs, SNRIs, TCAs, or MAOIs
- •Subjects with known hypersensitivity to methylene blue
- •Subjects with cardiac pacemaker or any other electrically powered implantable device.
- •Subjects not proficient in the English language.
- •Subject not in appropriate physical health to ride a stationary bicycle to the point of eliciting sweat.
- •Known allergy to iodine or potato starch.
研究组 & 干预措施
Treated side
Two test sites are chosen on the palms and randomized to treatment or control sides. Treatment side receives laser treatment of the sweat glands.
干预措施: Laser treatment (Device)
Untreated side
Two test sites are chosen on the palms and randomized to treatment or control sides. The control side is untreated.
结局指标
主要结局
Measurement of changes in sweat production using gravimetric method
时间窗: Measured at multiple time points, last at 6 months
Compare treated side to control side
Gravimetric Measurements of Changes in Sweat Production
时间窗: Assessed at baseline, week 1, week 2, week 4, month 3, and month 6
Subjects will be asked to exercise using a stationary bike until sweating is observable. After drying the surface, a pre-weighted filter paper under occlusive dressing (Tegaderm) is applied to the test site for a period of five minutes, measured by a stopwatch. After five minutes, the Tegaderm and absorptive pad are removed. The absorptive pad and Tegaderm are weighed before and after sweating, and rate of sweat production is calculated.
次要结局
未报告次要终点
研究者
Richard Rox Anderson, MD
Professor
Massachusetts General Hospital