Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- Change From Baseline in Palmar Sweat Production
研究概览
简要总结
This study will evaluate the use of hydrogel electrode pads (rather than tap water baths) to deliver iontophoresis treatment using a traditional iontophoresis device. Participants will treat one hand with the hydrogel-based iontophoresis device and leave the other hand untreated.
详细描述
Palmar hyperhidrosis affects 4.3 million Americans and results in substantial quality of life impairment. Treatment options for palmar hyperhidrosis include antiperspirants, systemic anticholinergic agents, botulinum toxin injections, and iontophoresis. Standard iontophoresis involves submerging the hands in tap water through which current is applied to the palms for 30 minutes per day up to 3 times per week. While effective, treatment adherence rates are low.
This study will evaluate the use of hydrogel electrode pads (rather than tap water baths) to deliver iontophoresis treatment using a traditional iontophoresis device. Hydrogel electrode pads permit improved mobility and hand functionality during iontophoresis treatment sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •13 years of age or older
- •>6 months self-reported history of primary palmar hyperhidrosis
- •Initial gravimetry test: >20mg/min on each palm
- •No topical treatments for hyperhidrosis (antiperspirants) on the palms for 2 weeks prior to the start of the study
- •No systemic treatments for hyperhidrosis (anticholinergics) for 4 weeks prior to the start of the study
- •No tap water iontophoresis treatment for 6 weeks
- •No Botox injections on the palms for 6 months (if single treatment session) or 10 months (if >1 previous sessions) prior to the start of the study
- •No history of cardiothoracic sympathectomy for hyperhidrosis
- •Able to attend 3 office visits (Stanford Medical Outpatient Center located at 450 Broadway St, Redwood City, CA 94063; Lucile Packard Children's Hospital at 730 Welch Road, 1st Floor, Palo Alto, CA 94304) and one virtual visit in an 8 week time frame
- •Capable of performing sweat level testing and hydrogel-based iontophoresis treatment at home, after training
- •Hydrogel electrode pad fits on the hand (typically tip of middle finger to lower end of palm length of 6.5in (16.5cm) or greater)
排除标准
- •Patients with implanted electronic medical devices e.g. pacemaker, implantable cardioverter/defibrillator)
- •Patients with metal implants in the extremity that will be treated
- •Patients with larger skin defects (on the palm or arm of the extremity that will be treated) that cannot be covered by petroleum jelly
- •Pregnant or nursing women, or looking to become pregnant
- •Patients on medications that interfere with neuroglandular transmission
- •Patients with active infection locally or systemically
- •Patients with history of contact dermatitis to acrylates
- •Patients with history of contact or systemic allergy to iodine
- •Patients with a history of ischemic heart disease, cardiac arrhythmias, epilepsy or thyroid disease
结局指标
主要结局
Change From Baseline in Palmar Sweat Production
时间窗: Baseline to week 2
Quantification of sweat production measured quantitatively using gravimetry, reported as milligrams of sweat per minute.
次要结局
- Patient Reported Pain (Visual Analogue Scale)(Baseline to week 2)
- Modified Minor's Sweat Testing as a Quantitative Measure of Palmar Sweat Production(Baseline to week 2)
研究者
Marlyanne Pol-Rodriguez
Clinical Assistant Professor
Stanford University