Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis
Phase: NA
Conditions: Hyperhidrosis, Hyperhidrosis Palmaris et Plantaris
Sponsor: Stanford University

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis 
NCT02854540 
August 15, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

STUDY PROTOCOL 
 
Subjects will be recruited from referrals by Dermatologists at Stanford Hospital and 
clinics, via self –referrals from recruitment flyers and from the Stanford Dermatology 
Clinics Stanford Hospital and clinics hyperhidrosis patient population. Patients will be 
screened for eligibility either in person during a routine clinical visit or over the phone.  
 
The study will consist of 3 treatment phases (daily treatment for 2 weeks, 3x/week 
treatment for 3 weeks and 2x/week treatment for 3 weeks) and a post-treatment 
evaluation.  
 
During the daily treatment phase, the subject will perform sweat level assessments and 
deliver treatment during office visits (1 in person and 1 virtual in this phase) and daily at 
home. The sweat level assessments will include gravimetry (in-office), 
visual assessment, iodine imprint testing (at home and in-office), and a  
study diary (at home and in-office), all commonly used methods to assess sweat levels 
for research purposes. Treatment will consist of 30 -60 minutes of hydrogel-based 
iontophoresis. During the  
three-time per week and two-time per week phases, the patients will undergo the 
allocated amount of treatments per week, perform iodine imprints at home and 
complete a study diary. There will be  
one office visit at the start of the 3x/week phase. The post- treatment evaluation will 
take place as an office visit.  
 
The first visit will be used to explain the study protocol, obtain informed consent, assess 
disease severity with baseline sweat level assessments, determine treatment settings, 
and provide training on performing the treatment and a study diary at home. Sweat 
level assessment will be obtained using gravimetry (quantitative measurement of sweat 
production by weight over a specified time period), iodine imprint testing (topical  
application of an iodine solution to qualitatively visualize sweat production after making 
an imprint on paper), and completion of a study diary. Study diary entries consist of a 
hyperhidrosis disease severity scale (HDSS) score (modified to reflect the severity of 
symptoms over a single day, visual pain assessment  
(Wong-Baker pain scale), and a prompt to specify general comments or any side effects 
related to the treatment. Treatment will consist of delivering a low level of direct 
electrical current to the palmar side of one hand.  
 
In line with standard tap water iontophoresis, amperage will be increased manually by 
the patient until the tingling induced by the current is at the upper limit of comfort. The 
current level will not be increased beyond 20 mA regardless of patient’s tolerance. The 
treatment may not be effective below a minimal  
therapeutic level (R.A. Fischer MD-2 manual). Therefore, if the subject finds low levels of 
current intolerable (e.g. below 6ma), the investigators may decide to exclude the 
subject from the study. The treatment duration will be up to 1 hour, consistent with 

what commercial devices are able to sustain (Hidrex DVP1000 user manual).  
 
During the various treatment phases, the subject will be asked to perform the following 
tasks independently at home: deliver treatments daily, triweekly or biweekly for a 
period of 2-3 weeks each, complete a daily questionnaire/study diary, and 
perform iodine imprint testing at least twice per week. Data will be collected through a 
REDCap survey. The patient will also be asked to photograph and store the paper 
imprints in a dedicated folder.  
 
A second contact point will be scheduled virtually within 2-4 days of the first visit to 
ensure that the subject is correctly performing the treatment, and to provide any 
additional training needed.  
 
After the end of the daily treatment phase (day 14, 15, 16 or 17), the subject will return 
to the office to perform treatment, complete gravimetry and iodine imprint sweat level 
assessments.  
 
The subject then enters treatment phases with decreased treatment frequency to 
3x/week for 3 weeks and 2x/week for 3 weeks. They will return to the office for a final 
evaluation visit and study  
wrap-up (day 56, 57, 58 or 59). 
 
STATISTICAL ANALYSIS PLAN 
 
We will be assessing the difference in sweat levels between the hands using gravimetry, 
iodine imprint  
testing, and symptom questionnaires. Gravimetry is commonly used in research settings 
to quantify sweat levels. Filter paper is weighed before and after application to 
the palmar surface of the hand for a fixed duration in time, e.g. 5 minutes. The weight 
difference quantifies the amount of sweat produced over a period of time (in mg/min). 
We will follow up changes in sweat levels based on data uploaded through REDCap. 
After the study the Student’s t-test will be used to assess sweat levels between the 
treated and untreated hands.  
 
Iodine paper imprint testing is a documented method to qualitatively assess sweat 
levels. The hands are cleaned and dried prior to application of iodine solution to the 
palmar sides of the hands. After the iodine solution has dried, subjects will apply steady 
pressure with their palms onto a sheet of paper. Sweat in contact with iodine and starch 
will produce a colorimetric change, with a purple-black color on the paper indicating the 
presence of sweat on the hands. The subject will take a photograph of this paper as a 
baseline qualitative measure of sweating and upload this onto the REDCap system 
through the  
survey diary. We will follow up changes in sweat levels on a daily basis based on data 

uploaded through REDCap. Differences in iodine imprint testing results between the left 
and right hand, and changes over the course of the study, will be assessed visually by a 
member of the research staff. After the study we will try to quantify the difference in 
sweat levels between the hands using image analysis software (e.g. ImageJ).  
Subjects will complete a survey diary with questions based on the Hyperhidrosis Disease 
Severity Scale (HDSS), a sweat assessment that is commonly used in hyperhidrosis 
studies. Modifications that we have made to the HDSS include distinguishing 
symptom severity of each hand and assessing overall symptom severity on a single day. 
Study diary responses will be reviewed by a member of the research staff on a daily 
basis