Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis

Trial ID or NCT#

NCT02854540

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis

Eligibility Criteria

Ages Eligible for Study: Older than 13 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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

Investigator(s)

Marlyanne Pol-Rodriguez, MD, FAAD
Marlyanne Pol-Rodriguez, MD, FAAD
General dermatologist
Clinical Associate Professor, Dermatology

Contact us to find out if this trial is right for you.

Contact

Veronique Peiffer, PhD