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N/A N=13 Treatment

Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis

Hyperhidrosis · Hyperhidrosis Palmaris et Plantaris

Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Change From Baseline in Palmar Sweat Production — 44.8; 43.2; 37.8; 24.9 mg/min

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Hydrogel electrode-based iontophoresis (Device)
Age
Pediatric, Adult, Older Adult · 13+ yrs
Sex
All
Sponsor
Stanford University
Primary completion
Aug 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Palmar Sweat Production
44.8; 43.2; 37.8; 24.9
SECONDARY
Patient Reported Pain (Visual Analogue Scale)
1.7
SECONDARY
Modified Minor's Sweat Testing as a Quantitative Measure of Palmar Sweat Production

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02854540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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