search
Back to results

Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis

Primary Purpose

Hyperhidrosis, Hyperhidrosis Palmaris et Plantaris

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hydrogel electrode-based iontophoresis
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperhidrosis focused on measuring hyperhidrosis, palmar, sweating, iontophoresis, sweat gland diseases, skin diseases

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford Children's Health - Dermatology Department
  • Stanford Medicine Outpatient Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

Change From Baseline in Palmar Sweat Production
Quantification of sweat production measured quantitatively using gravimetry, reported as milligrams of sweat per minute.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 30, 2016
Last Updated
November 17, 2019
Sponsor
Stanford University
search

1. Study Identification

Unique Protocol Identification Number
NCT02854540
Brief Title
Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis
Official Title
Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
August 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis, Hyperhidrosis Palmaris et Plantaris
Keywords
hyperhidrosis, palmar, sweating, iontophoresis, sweat gland diseases, skin diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hand A (iontophoresis) vs. Hand B (no treatment)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Hydrogel electrode-based iontophoresis
Intervention Description
Hydrogel was administered through iontophoresis, a process of transdermal drug delivery by use of a voltage gradient on the skin.
Primary Outcome Measure Information:
Title
Change From Baseline in Palmar Sweat Production
Description
Quantification of sweat production measured quantitatively using gravimetry, reported as milligrams of sweat per minute.
Time Frame
Baseline to week 2
Secondary Outcome Measure Information:
Title
Patient Reported Pain (Visual Analogue Scale)
Description
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.
Time Frame
Baseline to week 2
Title
Modified Minor's Sweat Testing as a Quantitative Measure of Palmar Sweat Production
Description
Modified Minor's starch iodine testing, done with iodine imprints on plain paper, performed in office and at home to quantitatively measure sweat production.
Time Frame
Baseline to week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marlyanne Pol-Rodriguez, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Children's Health - Dermatology Department
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Stanford Medicine Outpatient Center
City
Redwood City
State/Province
California
ZIP/Postal Code
94063-____
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://medlineplus.gov/ency/article/007293.htm
Description
MedlinePlus description of iontophoresis

Learn more about this trial

Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis

We'll reach out to this number within 24 hrs