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
|Condition or disease||Intervention/treatment||Phase|
|Hyperhidrosis Hyperhidrosis Palmaris et Plantaris||Device: Hydrogel electrode-based iontophoresis||Not Applicable|
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)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
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
|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-____|
|Principal Investigator:||Marlyanne Pol-Rodriguez, MD||Stanford University|