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Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis

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ClinicalTrials.gov Identifier: NCT02854540
Recruitment Status : Active, not recruiting
First Posted : August 3, 2016
Last Update Posted : June 29, 2018
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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 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
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sweat

Arm Intervention/treatment
Hand A (iontophoresis) vs. Hand B (no treatment)
Hand A will be treated with hydrogel electrode-based iontophoresis. Hand B will not receive treatment.
Device: Hydrogel electrode-based iontophoresis
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.




Primary Outcome Measures :
  1. Gravimetry as a quantitative measure of palmar sweat production [ Time Frame: up to 8 weeks ]
    Quantification of sweat production by gravimetry will be performed at 3 office visits to quantitatively measure sweat production during the treatment phase


Secondary Outcome Measures :
  1. Modified Minor's sweat testing as a qualitative measure of palmar sweat production [ Time Frame: up to 8 weeks ]
    Modified Minor's starch iodine testing, done with iodine imprints on plain paper, will be performed in office and at home to qualitatively measure sweat production during the treatment phase and follow up phase

  2. Survey diary [ Time Frame: up to 8 weeks ]
    Participants will complete a daily study diary reporting symptom severity and comments on the iontophoresis treatment



Information from the National Library of Medicine

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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; LPCH 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
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
Principal Investigator: Marlyanne Pol-Rodriguez, MD Stanford University

Additional Information:
Responsible Party: Marlyanne Pol-Rodriguez, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02854540     History of Changes
Other Study ID Numbers: 37987
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Marlyanne Pol-Rodriguez, Stanford University:
hyperhidrosis
palmar
sweating
iontophoresis
sweat gland diseases
skin diseases

Additional relevant MeSH terms:
Hyperhidrosis
Sweat Gland Diseases
Skin Diseases