Clinical trial NCT02854540: Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis
Official title: Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperhidrosis
Hyperhidrosis Palmaris et Plantaris
Keywords: hyperhidrosis
palmar
sweating
iontophoresis
sweat gland diseases
skin diseases
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 13
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Change From Baseline in Palmar Sweat Production
timeFrame: Baseline to week 2
Secondary outcomes:
measure: Patient Reported Pain (Visual Analogue Scale)
timeFrame: Baseline to week 2
measure: Modified Minor's Sweat Testing as a Quantitative Measure of Palmar Sweat Production
timeFrame: Baseline to week 2
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Children's Health - Dermatology Department
state: California
city: Redwood City
country: United States
facility: Stanford Medicine Outpatient Center
state: California
Study officials:
affiliation: Stanford University
name: Marlyanne Pol-Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
References: