Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis

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.

Study Overview

• Status: Completed
• Conditions: Hyperhidrosis; Hyperhidrosis Palmaris et Plantaris
• Intervention / Treatment: Device: Hydrogel electrode-based iontophoresis

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford Children's Health - Dermatology Department
    • Redwood City, California, United States, 94063-____
      • Stanford Medicine Outpatient Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hand A (iontophoresis) vs. Hand B (no treatment); 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.	Device: Hydrogel electrode-based iontophoresis; Hydrogel was administered through iontophoresis, a process of transdermal drug delivery by use of a voltage gradient on the skin.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Pain (Visual Analogue Scale)	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.	Baseline to week 2
Modified Minor's Sweat Testing as a Quantitative Measure of Palmar Sweat Production	Modified Minor's starch iodine testing, done with iodine imprints on plain paper, performed in office and at home to quantitatively measure sweat production.	Baseline to week 2

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Marlyanne Pol-Rodriguez, MD, Stanford University

Publications and helpful links

Helpful Links

• MedlinePlus description of iontophoresis

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): August 30, 2018
• Study Completion (Actual): August 30, 2018

Study Registration Dates

• First Submitted: July 30, 2016
• First Submitted That Met QC Criteria: July 30, 2016
• First Posted (Estimate): August 3, 2016

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 17, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: skin diseases; iontophoresis; sweating; hyperhidrosis; palmar; sweat gland diseases
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis
• Other Study ID Numbers: 37987

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes