Primary outcomeMean· Assessed at baseline, week 1, week 2, week 4, month 3, and month 6
Gravimetric Measurements of Changes in Sweat Production
| Group | Value (grams) | Spread |
|---|---|---|
| Treated Side | 0.0057 | 0.0028 |
| Untreated Side | 0.0056 | 0.0050 |
Trial · Interventional
TerminatedNot applicableResults postedRegistry dataImage Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis
NCTNCT04178161 (opens ClinicalTrials.gov in a new tab)Other id2016P001071
This trial was stopped early.
Reason given at the registry: Collaboration with company that made the laser did not proceed.
Results were posted for this trial.
This trial does not test a peptide that PepBank tracks.
- Measures Methylene blue, does not give it. It appears in the eligibility rules.
Overview
- Status
- Terminated
- Phase
- Not applicable
- Enrollment
- 2 participants (actual)
- Sponsor
- Massachusetts General Hospital · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- 1 Sept 2016
- Primary completion
- 1 May 2021
- Completion
- 1 May 2021
- First posted
- 26 Nov 2019
- Last update posted
- 26 Jun 2026
- Conditions
- Hyperhidrosis
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2016201720182019202020212022
- N/ATerminated
Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis
NCT041781611 Sept 2016 to 1 May 2021
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Laser treatmentDevice
Arms2
Experimental
Treated side
Two test sites are chosen on the palms and randomized to treatment or control sides. Treatment side receives laser treatment of the sweat glands.
No intervention
Untreated side
Two test sites are chosen on the palms and randomized to treatment or control sides. The control side is untreated.
Primary outcomes1
Outcomes the sponsor listed as primary.
Gravimetric Measurements of Changes in Sweat Production
Time frame · Assessed at baseline, week 1, week 2, week 4, month 3, and month 6
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Treated SideTwo regions are designated one on each palm. Randomized to treatment and control sides. 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. | 0 / 2 | 0 / 2 | 0 / 2 |
| Untreated SideTwo regions are designated, one on each palm. Randomized to treatment and control sides. Control side is untreated. | 0 / 2 | 0 / 2 | 0 / 2 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 65 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
1. Subjects of ages between 18 and 65 years.
2. Subjects with any Fitzpatrick skin type.
3. Subjects who are proficient in the English language.
4. Willingness to participate in the study.
5. Willingness to undergo experimental procedure.
6. Informed consent agreement signed by the subject.
7. Willingness to follow the follow-up schedule.
8. Willingness not to use any other hyperhidrosis treatment to the tests sites during the study period (i.e. deodorant, at-home iontophoresis, Botox, MiraDry).
9. Patient rates symptoms at level "3" or "4" on the hyperhidrosis disease severity scale (HDSS, see below).
10. Subject in appropriate physical health to ride a stationary bicycle to the point of eliciting sweat.
11. No known allergy to iodine or potato starch
Exclusion Criteria:
1. Pregnancy
2. Subjects on systemic treatment for hyperhidrosis, such as anticholinergic drugs (e.g. glycopyrrolate), sedatives or tranquilizers, within the past 8 weeks.
3. Subjects who have undergone surgical excision of sweat glands or sympathectomy for hyperhidrosis.
4. Subjects with an underlying disorder, such as neurologic injury or disease affecting the autonomic system, vascular disorders and metabolic disorders (e.g. hyperthyroidism, diabetes mellitus) that can produce hyperhidrosis
5. Subjects with a history of coronary artery disease.
6. Subjects with a history of poor compliance or psychosis
7. Subjects taking SSRIs, SNRIs, TCAs, or MAOIs
8. Subjects with known hypersensitivity to methylene blue
9. Subjects with cardiac pacemaker or any other electrically powered implantable device.
10. Subjects not proficient in the English language.
11. Subject not in appropriate physical health to ride a stationary bicycle to the point of eliciting sweat.
12. Known allergy to iodine or potato starch.
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