Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis

Not Applicable

Completed

Brief 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Hand A (iontophoresis) vs. Hand B (no treatment)	Hydrogel electrode-based iontophoresis	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Palmar Sweat Production	Baseline to week 2	Quantification of sweat production measured quantitatively using gravimetry, reported as milligrams of sweat per minute.

Secondary Outcome Measures

Name	Time	Method
Patient Reported Pain (Visual Analogue Scale)	Baseline to week 2	Patient-reported pain on the treated hand using an 11-point visual analogue scale. Scale range: 0-10, with zero representing no pain, and 10 representing the worst pain imaginable. Participants recorded pain scores in a daily diary, and the score reported here is the average of all scores reported over the 2-week treatment period.
Modified Minor's Sweat Testing as a Quantitative Measure of Palmar Sweat Production	Baseline to week 2	Modified Minor's starch iodine testing, done with iodine imprints on plain paper, performed in office and at home to quantitatively measure sweat production.

Locations (2): Stanford Medicine Outpatient Center
🇺🇸
Redwood City, California, United States
Stanford Children's Health - Dermatology Department
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Palo Alto, California, United States