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Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02854540
Recruitment Status : Completed
First Posted : August 3, 2016
Results First Posted : November 18, 2019
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Marlyanne Pol-Rodriguez, Stanford University

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.

Condition or disease Intervention/treatment Phase
Hyperhidrosis Hyperhidrosis Palmaris et Plantaris Device: Hydrogel electrode-based iontophoresis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis
Actual Study Start Date : August 2016
Actual Primary Completion Date : August 30, 2018
Actual Study Completion Date : August 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sweat

Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. Change From Baseline in Palmar Sweat Production [ Time Frame: Baseline to week 2 ]
    Quantification of sweat production measured quantitatively using gravimetry, reported as milligrams of sweat per minute.


Secondary Outcome Measures :
  1. Patient Reported Pain (Visual Analogue Scale) [ Time Frame: Baseline to week 2 ]

    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.


  2. Modified Minor's Sweat Testing as a Quantitative Measure of Palmar Sweat Production [ Time Frame: Baseline to week 2 ]
    Modified Minor's starch iodine testing, done with iodine imprints on plain paper, performed in office and at home to quantitatively measure sweat production.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02854540


Locations
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United States, California
Stanford Children's Health - Dermatology Department
Palo Alto, California, United States, 94304
Stanford Medicine Outpatient Center
Redwood City, California, United States, 94063-____
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Marlyanne Pol-Rodriguez, MD Stanford University
  Study Documents (Full-Text)

Documents provided by Marlyanne Pol-Rodriguez, Stanford University:

Additional Information:
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Responsible Party: Marlyanne Pol-Rodriguez, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02854540    
Other Study ID Numbers: 37987
First Posted: August 3, 2016    Key Record Dates
Results First Posted: November 18, 2019
Last Update Posted: November 26, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Marlyanne Pol-Rodriguez, Stanford University:
hyperhidrosis
palmar
sweating
iontophoresis
sweat gland diseases
skin diseases
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases