Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis

Hyperhidrosis Clinical Trial

Official title:

Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02854540
• Other study ID #: 37987
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: August 30, 2018

Study information

• Verified date: November 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperhidrosis
• Hyperhidrosis Palmaris et Plantaris

Intervention

Device:
• Hydrogel electrode-based iontophoresis
Hydrogel was administered through iontophoresis, a process of transdermal drug delivery by use of a voltage gradient on the skin.

Locations

Country	Name	City	State
United States	Stanford Children's Health - Dermatology Department	Palo Alto	California
United States	Stanford Medicine Outpatient Center	Redwood City	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Palmar Sweat Production	Quantification of sweat production measured quantitatively using gravimetry, reported as milligrams of sweat per minute.	Baseline to week 2
Secondary	Patient Reported Pain (Visual Analogue Scale)	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.	Baseline to week 2
Secondary	Modified Minor's Sweat Testing as a Quantitative Measure of Palmar Sweat Production	Modified Minor's starch iodine testing, done with iodine imprints on plain paper, performed in office and at home to quantitatively measure sweat production.	Baseline to week 2

External Links

•   MedlinePlus description of iontophoresis