Trial Outcomes & Findings for Management of Palmar Hyperhidrosis With Hydrogel-based Iontophoresis (NCT NCT02854540)

Results Overview

Quantification of sweat production measured quantitatively using gravimetry, reported as milligrams of sweat per minute.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

Baseline to week 2

Results posted on

2019-11-26

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	13
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=13 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.
Age, Categorical <=18 years	2 Participants n=13 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=13 Participants
Age, Categorical >=65 years	0 Participants n=13 Participants
Sex: Female, Male Female	6 Participants n=13 Participants
Sex: Female, Male Male	7 Participants n=13 Participants
Region of Enrollment United States	13 participants n=13 Participants

PRIMARY outcome

Timeframe: Baseline to week 2

Population: Two participants who were not able to tolerate the lower threshold dose were excluded from the analysis.

Quantification of sweat production measured quantitatively using gravimetry, reported as milligrams of sweat per minute.

Outcome measures

Outcome measures
Measure	Hand A (Iontophoresis) n=11 Hands 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.	Hand B (no Treatment) n=11 Hands 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.
Change From Baseline in Palmar Sweat Production Baseline	44.8 mg/min Standard Deviation 25.34	43.2 mg/min Standard Deviation 24.77
Change From Baseline in Palmar Sweat Production Week 2	37.8 mg/min Standard Deviation 41.07	24.9 mg/min Standard Deviation 17.87

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Hand A (Iontophoresis) n=11 Participants 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.	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.
Patient Reported Pain (Visual Analogue Scale)	1.7 score on a scale Standard Deviation 1.25	—

SECONDARY outcome

Timeframe: Baseline to week 2

Population: No data were collected for this outcome measure.

Modified Minor's starch iodine testing, done with iodine imprints on plain paper, performed in office and at home to quantitatively measure sweat production.

Outcome measures

Outcome data not reported

Adverse Events

Hand A (Iontophoresis)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Hand B (no Treatment)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Hand A (Iontophoresis) n=13 participants at risk 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.	Hand B (no Treatment) n=13 participants at risk 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.
Skin and subcutaneous tissue disorders itching	46.2% 6/13 • 2 week treatment period plus 6 week follow-up	0.00% 0/13 • 2 week treatment period plus 6 week follow-up
Skin and subcutaneous tissue disorders blister	15.4% 2/13 • 2 week treatment period plus 6 week follow-up	0.00% 0/13 • 2 week treatment period plus 6 week follow-up
Skin and subcutaneous tissue disorders crack/fissure	7.7% 1/13 • 2 week treatment period plus 6 week follow-up	0.00% 0/13 • 2 week treatment period plus 6 week follow-up
Skin and subcutaneous tissue disorders minor skin burn	7.7% 1/13 • 2 week treatment period plus 6 week follow-up	0.00% 0/13 • 2 week treatment period plus 6 week follow-up

Additional Information

Dr. Marlyanne Pol-Rodriguez

Stanford School of Medicine

Phone: 650-721-7144

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place