An interventional study of Laser treatment in Hyperhidrosis, sponsored by Massachusetts General Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
Hyperhidrosis is a condition in which sweating is in excess of that required for normal regulation of body temperature. Commonly affected areas in primary hyperhidrosis include axillae, palms and soles. Secondary hyperhidrosis can affect scalp, face, neck, back, groin and legs. Hyperhidrosis can negatively impact, employment, relationships, or other aspects of quality of life.
The investigators propose to investigate the use of a unique image-guided laser to specifically ablate eccrine sweat glands.
111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.
This study's enrollment of 2 is below the median of 50 across 99 interventional studies indexed under Hyperhidrosis.
Browse Hyperhidrosis studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two test sites are chosen on the palms and randomized to treatment or control sides. Treatment side receives laser treatment of the sweat glands.
Device: Laser treatment
Two test sites are chosen on the palms and randomized to treatment or control sides. The control side is untreated.
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.
Gravimetric Measurements of Changes in Sweat Production
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.
Time frame: Assessed at baseline, week 1, week 2, week 4, month 3, and month 6
| Milestone | Treated Side | Untreated Side |
|---|---|---|
| Started | 2 | 2 |
| Completed | 2 | 2 |
| Not completed | 0 | 0 |
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.
| grams | Treated Side | Untreated Side |
|---|---|---|
| Baseline | 0.0057 ± 0.0028 | 0.0056 ± 0.0050 |
| Week 1 | 0.0040 | 0.0357 |
| Week 2 | 0.0053 | 0.0160 |
| Week 4 | 0.0052 ± 0.0050 | 0.0046 ± 0.0029 |
| Month 3 | 0.0114 ± 0.0105 | 0.0055 ± 0.0027 |
| Month 6 | 0.0488 ± 0.0426 | 0.0374 ± 0.0341 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treated Side | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Untreated Side | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | All Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 0 |
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 43.5 ± 26.2 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 2 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | All Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Gravimetric measurements of changes in sweat production(grams) | All Participants |
|---|---|
| Mean | 0.1275 ± 0.0028 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2016 to primary completion in May 2021, 56 months.
Results were first posted in Jun 2026, 5 years 1 month after primary completion.
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This study is terminated, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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