Hyperhidrosis, Hyperhidrosis Palmaris et Plantaris
Conditions
Keywords
hyperhidrosis, palmar, sweating, iontophoresis, sweat gland diseases, skin diseases
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.
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.
Interventions
DEVICEHydrogel electrode-based iontophoresis
Hydrogel was administered through iontophoresis, a process of transdermal drug delivery by use of a voltage gradient on the skin.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Palmar Sweat Production | Baseline to week 2 | Quantification of sweat production measured quantitatively using gravimetry, reported as milligrams of sweat per minute. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Pain (Visual Analogue Scale) | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Hand A was treated with hydrogel electrode-based iontophoresis. Hand B did not receive treatment.
Hydrogel electrode-based iontophoresis: During the treatment period, participants were asked to treat one hand with the hydrogel electrode-based iontophoresis device. Participants were also asked to leave the other hand untreated. | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 2 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 11 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 13 participants | — |
| Sex: Female, Male Female | 6 Participants | — |
| Sex: Female, Male Male | 7 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 6 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
Primary
Change From Baseline in Palmar Sweat Production
Quantification of sweat production measured quantitatively using gravimetry, reported as milligrams of sweat per minute.
Time frame: Baseline to week 2
Population: Two participants who were not able to tolerate the lower threshold dose were excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hand A (Iontophoresis) | Change From Baseline in Palmar Sweat Production | Baseline | 44.8 mg/min | Standard Deviation 25.34 |
| Hand A (Iontophoresis) | Change From Baseline in Palmar Sweat Production | Week 2 | 37.8 mg/min | Standard Deviation 41.07 |
| Hand B (no Treatment) | Change From Baseline in Palmar Sweat Production | Baseline | 43.2 mg/min | Standard Deviation 24.77 |
| Hand B (no Treatment) | Change From Baseline in Palmar Sweat Production | Week 2 | 24.9 mg/min | Standard Deviation 17.87 |
Secondary
Modified Minor's Sweat Testing as a Quantitative Measure of Palmar Sweat Production
Modified Minor's starch iodine testing, done with iodine imprints on plain paper, performed in office and at home to quantitatively measure sweat production.
Time frame: Baseline to week 2
Population: No data were collected for this outcome measure.
Secondary
Patient Reported Pain (Visual Analogue Scale)
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.
Time frame: Baseline to week 2
Population: Two participants who were not able to tolerate the lower threshold dose were excluded from the analysis. This outcome was prespecified for the treated hand only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hand A (Iontophoresis) | Patient Reported Pain (Visual Analogue Scale) | 1.7 score on a scale | Standard Deviation 1.25 |