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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hand A (iontophoresis) vs. Hand B (no treatment) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrogel electrode-based iontophoresis | Device | Hydrogel was administered through iontophoresis, a process of transdermal drug delivery by use of a voltage gradient on the skin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Palmar Sweat Production | Quantification of sweat production measured quantitatively using gravimetry, reported as milligrams of sweat per minute. | Baseline to week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to week 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marlyanne Pol-Rodriguez, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Children's Health - Dermatology Department | Palo Alto | California | 94304 | United States | ||
| Stanford Medicine Outpatient Center |
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| Label | URL |
|---|---|
| MedlinePlus description of iontophoresis | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Healthy teenagers and adults with a history of palmar hyperhidrosis
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Palmar Sweat Production | Quantification of sweat production measured quantitatively using gravimetry, reported as milligrams of sweat per minute. | Two participants who were not able to tolerate the lower threshold dose were excluded from the analysis. | Posted | Mean | Standard Deviation | mg/min | Baseline to week 2 | Hands | Hands |
|
2 week treatment period plus 6 week follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hand A (Iontophoresis) | Hand A was treated with hydrogel electrode-based iontophoresis. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marlyanne Pol-Rodriguez | Stanford School of Medicine | 650-721-7144 | mpr@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 15, 2019 | Sep 18, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006945 | Hyperhidrosis |
| C563185 | Hyperhidrosis Palmaris Et Plantaris |
| D013543 | Sweat Gland Diseases |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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| 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. | Baseline to week 2 |
| Redwood City |
| California |
| 94063-____ |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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. |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to week 2 |
|
|
|
| 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. | No data were collected for this outcome measure. | Posted | Baseline to week 2 |
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 6 |
| 13 |
| EG001 | Hand B (no Treatment) | 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. | 0 | 13 | 0 | 13 | 0 | 13 |
| blister | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| crack/fissure | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| minor skin burn | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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