Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis

NCT02854540 | Completed Results FDA Device

• 1 other identifier: 37987
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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.

Conditions

Hyperhidrosis; Hyperhidrosis Palmaris et Plantaris

Keywords

hyperhidrosis; palmar; sweating; iontophoresis; sweat gland diseases; skin diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient Reported Pain (Visual Analogue Scale)

  Baseline to week 2

• Modified Minor's Sweat Testing as a Quantitative Measure of Palmar Sweat Production

  Baseline to week 2

Study Arms (1)

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

EXPERIMENTAL

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.

Device: Hydrogel electrode-based iontophoresis

Interventions

Hydrogel electrode-based iontophoresis DEVICE

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

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

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (2)

Stanford Children's Health - Dermatology Department

Palo Alto, California, 94304, United States

Location

Stanford Medicine Outpatient Center

Redwood City, California, 94063-____, United States

Location

Related Links

• MedlinePlus description of iontophoresis

MeSH Terms

Conditions

Hyperhidrosis; Hyperhidrosis Palmaris Et Plantaris; Sweat Gland Diseases; Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Marlyanne Pol-Rodriguez
• Organization: Stanford School of Medicine

mpr@stanford.edu

650-721-7144

Study Officials

• Marlyanne Pol-Rodriguez, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: July 30, 2016
• First Posted: August 3, 2016
• Study Start: August 1, 2016
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: November 26, 2019
• Results First Posted: November 18, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)