Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis

Stanford University

Status: Completed

Conditions: Hyperhidrosis; Hyperhidrosis Palmaris et Plantaris

Treatments: Device: Hydrogel electrode-based iontophoresis

Study type: Interventional

Funder types: Other

Identifiers

NCT02854540

37987

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 13 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Hand A (iontophoresis) vs. Hand B (no treatment)

Experimental group

Description:

During the treatment period, participants will be asked to treat one hand with the hydrogel electrode-based iontophoresis device. Participants will also be asked to leave the other hand untreated.

Treatment:

Device: Hydrogel electrode-based iontophoresis