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Completed

NCT Number: NCT02854540

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.

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Key information

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Children's Health - Dermatology Department, Palo Alto, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrogel electrode-based iontophoresis

Device

Hydrogel was administered through iontophoresis, a process of transdermal drug delivery by use of a voltage gradient on the skin.

Primary outcomes

  1. Change From Baseline in Palmar Sweat Production

    Time frame: Baseline to week 2

    Quantification of sweat production measured quantitatively using gravimetry, reported as milligrams of sweat per minute.

Secondary outcomes

  1. Patient Reported Pain (Visual Analogue Scale)

    Time frame: 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.

  2. Modified Minor's Sweat Testing as a Quantitative Measure of Palmar Sweat Production

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 3, 2016
Registry last updated
Nov 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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