Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis

Completed · Not applicable

Conditions studied: Hyperhidrosis, Hyperhidrosis Palmaris et Plantaris

In brief

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.

Key facts

Study ID

NCT02854540

Run by

Stanford University

People needed

13

Starts

2016-08-01

Expected to finish

2018-08-30

Last updated by the study team

2019-11-26

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Stanford Children's Health - Dermatology Department — Palo Alto, California, United States
• Stanford Medicine Outpatient Center — Redwood City, California, United States

Full record on ClinicalTrials.gov

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