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 : Active, not recruiting
First Posted : August 3, 2016
Last Update Posted : June 29, 2018
|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)|
|Estimated Enrollment :||18 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|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2018|
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.
- 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
- 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
- Survey diary [ Time Frame: up to 8 weeks ]Participants will complete a daily study diary reporting symptom severity and comments on the iontophoresis treatment
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|