Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis (NCT02854540) | Clinical Trial Compass
CompletedNot Applicable
Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis
United States13 participantsStarted 2016-08
Plain-language summary
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.
Who can participate
Age range
13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.