Trial Outcomes & Findings for Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis (NCT NCT04178161)
NCT ID: NCT04178161
Last Updated: 2026-06-26
Results Overview
Subjects will be asked to exercise using a stationary bike until sweating is observable. After drying the surface, a pre-weighted filter paper under occlusive dressing (Tegaderm) is applied to the test site for a period of five minutes, measured by a stopwatch. After five minutes, the Tegaderm and absorptive pad are removed. The absorptive pad and Tegaderm are weighed before and after sweating, and rate of sweat production is calculated.
TERMINATED
NA
2 participants
Assessed at baseline, week 1, week 2, week 4, month 3, and month 6
2026-06-26
Participant Flow
Unit of analysis: Palms
Participant milestones
| Measure |
Treated Side
Two regions are designated, one on each palm and randomized to treatment or control.
The treatment side receives laser treatment of the sweat glands.
Laser treatment: Iontophoresis of methylene blue is used to identify the sweat glands. An image guided fractional erbium laser is used to specifically target these glands for ablation.
|
Untreated Side
Two regions are designated, one on each palm and randomized to treatment and control sides.
The control side is untreated.
|
|---|---|---|
|
Overall Study
STARTED
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2 2
|
2 2
|
|
Overall Study
COMPLETED
|
2 2
|
2 2
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
2 subjects were analyzed. Each subject had a treatment side and a control side. Thus there were a total of two subjects with a total of 4 sides (2 treatment and 2 control).
Baseline characteristics by cohort
| Measure |
All Participants
n=4 Palms
This is a split-person study where all participants were allocated to both treatment and control groups.
Two regions were designated, one on each palm, and randomized to treatment or control. The treatment side receives laser treatment of the sweat glands. The control side receives no intervention.
On the treatment side, iontophoresis of methylene blue is used to identify the sweat glands. An image guided fractional erbium laser is used to specifically target these glands for ablation.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
|
Age, Continuous
|
43.5 years
STANDARD_DEVIATION 26.2 • n=20 Participants • 2 subjects were analyzed. Each subject had a treatment side and a control side. Thus there were a total of two subjects with a total of 4 sides (2 treatment and 2 control).
|
|
Sex: Female, Male
Female
|
2 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Gravimetric measurements of changes in sweat production
|
0.1275 grams
STANDARD_DEVIATION 0.0028 • n=4 Palms
|
PRIMARY outcome
Timeframe: Assessed at baseline, week 1, week 2, week 4, month 3, and month 6Population: Subject 1 missed week 1 and week 3 visits.
Subjects will be asked to exercise using a stationary bike until sweating is observable. After drying the surface, a pre-weighted filter paper under occlusive dressing (Tegaderm) is applied to the test site for a period of five minutes, measured by a stopwatch. After five minutes, the Tegaderm and absorptive pad are removed. The absorptive pad and Tegaderm are weighed before and after sweating, and rate of sweat production is calculated.
Outcome measures
| Measure |
Treated Side
n=2 Participants
Two test sites are chosen on the palms (one on each palm) and randomized to treatment or control sides. The treatment side receives laser treatment of the sweat glands.
Laser treatment: Iontophoresis of methylene blue is used to identify the sweat glands. An image guided fractional erbium laser is used to specifically target these glands for ablation.
|
Untreated Side
n=2 Participants
Two test sites are chosen on the palms (one on each palm) and randomized to treatment or control sides.
The control side is untreated.
|
|---|---|---|
|
Gravimetric Measurements of Changes in Sweat Production
Baseline
|
0.0057 grams
Standard Deviation 0.0028
|
0.0056 grams
Standard Deviation 0.0050
|
|
Gravimetric Measurements of Changes in Sweat Production
Week 1
|
0.0040 grams
|
0.0357 grams
|
|
Gravimetric Measurements of Changes in Sweat Production
Week 2
|
0.0053 grams
|
0.0160 grams
|
|
Gravimetric Measurements of Changes in Sweat Production
Week 4
|
0.0052 grams
Standard Deviation 0.0050
|
0.0046 grams
Standard Deviation 0.0029
|
|
Gravimetric Measurements of Changes in Sweat Production
Month 3
|
0.0114 grams
Standard Deviation 0.0105
|
0.0055 grams
Standard Deviation 0.0027
|
|
Gravimetric Measurements of Changes in Sweat Production
Month 6
|
0.0488 grams
Standard Deviation 0.0426
|
0.0374 grams
Standard Deviation 0.0341
|
Adverse Events
Treated Side
Untreated Side
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place