HyperhidrosisNCT02854540
Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis
A study testing Hydrogel electrode-based iontophoresis in people with Hyperhidrosis and Hyperhidrosis Palmaris et Plantaris, run by Stanford University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Hyperhidrosis, Hyperhidrosis Palmaris et Plantaris
- What is being tested?
- Hydrogel electrode-based iontophoresis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2016to 30 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stanford Children's Health - Dermatology Department
Palo Alto, California, 94304
Stanford Medicine Outpatient Center
Redwood City, California, 94063-____
About this study
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.
Read the 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
- Being tested
- Hydrogel electrode-based iontophoresis
- Keywords
- hyperhidrosis, palmar, sweating, iontophoresis, sweat gland diseases, skin diseases
- Medical subject headings
- Hyperhidrosis, Hyperhidrosis Palmaris Et Plantaris, Sweat Gland Diseases, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogel electrode-based iontophoresisDevice
Hydrogel was administered through iontophoresis, a process of transdermal drug delivery by use of a voltage gradient on the skin.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Hydrogel electrode-based iontophoresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Palmar Sweat Production
Quantification of sweat production measured quantitatively using gravimetry, reported as milligrams of sweat per minute.
Measured: Baseline to week 2
Secondary outcomes (2)
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.
Measured: Baseline to week 2
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.
Measured: Baseline to week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HyperhidrosisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlyanne Pol-Rodriguez, Stanford University
- Investigators
- Marlyanne Pol-Rodriguez, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854540
- Sponsor's protocol ID
- 37987
- Status last verified
- Nov 2019
- First submitted
- 30 Jul 2016
- Last updated
- 26 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis
- ClinicalTrials.gov ID
- NCT02854540
- Acronym / sponsor ID
- 37987
- Conditions
- Hyperhidrosis, Hyperhidrosis Palmaris et Plantaris
- Keywords
- hyperhidrosis, palmar, sweating, iontophoresis, sweat gland diseases, skin diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Posted 18 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hand A (iontophoresis) vs. Hand B (no treatment) | Experimental | Device: Hydrogel electrode-based iontophoresisDuring 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. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrogel electrode-based iontophoresisHydrogel was administered through iontophoresis, a process of transdermal drug delivery by use of a voltage gradient on the skin. | Device | Hand A (iontophoresis) vs. Hand B (no treatment) |
Primary outcome
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.
2 secondary outcomes
Patient Reported Pain (Visual Analogue Scale)
Time frame: Baseline to week 2
Modified Minor's Sweat Testing as a Quantitative Measure of Palmar Sweat Production
Time frame: Baseline to week 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MedlinePlus description of iontophoresisLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlyanne Pol-Rodriguez, MD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrogel electrode-based iontophoresis in people with Hyperhidrosis and Hyperhidrosis Palmaris et Plantaris, run by Stanford University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Palmar Sweat Production (time frame: Baseline to week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.