Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis

NCT ID: NCT02854540

Last Updated: 2019-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-08-30

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.

Conditions

Hyperhidrosis; Hyperhidrosis Palmaris et Plantaris

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hand A (iontophoresis) vs. Hand B (no treatment)

During the treatment period, participants will be asked to treat one hand with the hydrogel electrode-based iontophoresis device. Participants will also be asked to leave the other hand untreated.

Group Type: EXPERIMENTAL

Hydrogel electrode-based iontophoresis

Intervention Type: DEVICE

Hydrogel was administered through iontophoresis, a process of transdermal drug delivery by use of a voltage gradient on the skin.

Interventions

Hydrogel electrode-based iontophoresis

Hydrogel was administered through iontophoresis, a process of transdermal drug delivery by use of a voltage gradient on the skin.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Marlyanne Pol-Rodriguez

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marlyanne Pol-Rodriguez, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford Children's Health - Dermatology Department

Palo Alto, California, United States

Stanford Medicine Outpatient Center

Redwood City, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://medlineplus.gov/ency/article/007293.htm

MedlinePlus description of iontophoresis

Other Identifiers

37987

Identifier Type: -

Identifier Source: org_study_id