N/A
N=13
Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis
Hyperhidrosis · Hyperhidrosis Palmaris et Plantaris
Bottom Line
View on ClinicalTrials.gov: NCT02854540 ↗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
| Outcome | Result | p-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
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.