NCT02854540

Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperhidrosis
• Hyperhidrosis Palmaris et Plantaris

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-08-01
• Primary completion: 2018-08-30
• Completion: 2018-08-30
• First posted: 2016-08-03
• Last updated: 2019-11-26
• Results posted: 2019-11-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study