HyperhidrosisNCT04178161
Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis
A study testing Laser treatment in people with Hyperhidrosis, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperhidrosis
- What is being tested?
- Laser treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 1 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects of ages between 18 and 65 years.
- Subjects with any Fitzpatrick skin type.
- Subjects who are proficient in the English language.
- Willingness to participate in the study.
- Willingness to undergo experimental procedure.
- Informed consent agreement signed by the subject.
Show all 11Show fewer
- Willingness to follow the follow-up schedule.
- Willingness not to use any other hyperhidrosis treatment to the tests sites during the study period (i.e. deodorant, at-home iontophoresis, Botox, MiraDry).
- Patient rates symptoms at level "3" or "4" on the hyperhidrosis disease severity scale (HDSS, see below).
- Subject in appropriate physical health to ride a stationary bicycle to the point of eliciting sweat.
- No known allergy to iodine or potato starch
Who cannot join
- Pregnancy
- Subjects on systemic treatment for hyperhidrosis, such as anticholinergic drugs (e.g. glycopyrrolate), sedatives or tranquilizers, within the past 8 weeks.
- Subjects who have undergone surgical excision of sweat glands or sympathectomy for hyperhidrosis.
- 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
- Subjects with a history of coronary artery disease.
- Subjects with a history of poor compliance or psychosis
Show all 12Show fewer
- Subjects taking SSRIs, SNRIs, TCAs, or MAOIs
- Subjects with known hypersensitivity to methylene blue
- Subjects with cardiac pacemaker or any other electrically powered implantable device.
- Subjects not proficient in the English language.
- Subject not in appropriate physical health to ride a stationary bicycle to the point of eliciting sweat.
- Known allergy to iodine or potato starch.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital - Wellman Center for Photomedicine
Boston, Massachusetts, 02114
About this study
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.
- Conditions
- Hyperhidrosis
- Being tested
- Laser treatment
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser treatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treated side | Experimental | Two test sites are chosen on the palms and randomized to treatment or control sides. Treatment side receives laser treatment of the sweat glands. Receives: Device: Laser treatment |
| Untreated side | No intervention | Two test sites are chosen on the palms and randomized to treatment or control sides. The control side is untreated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at baseline, week 1, week 2, week 4, month 3, and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start1 Sep 2016
- Primary completion1 May 2021
- Study completion1 May 2021
Why it stopped: Collaboration with company that made the laser did not proceed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HyperhidrosisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study involves a single group of patients with Hyperhidrosis. Left and right palms are randomized for treatment versus control (untreated).
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sciton
- Responsible party
- Principal investigator, Richard Rox Anderson, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178161
- Sponsor's protocol ID
- 2016P001071
- Status last verified
- Nov 2023
- First submitted
- 17 Sep 2019
- Last updated
- 26 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis
- ClinicalTrials.gov ID
- NCT04178161
- Acronym / sponsor ID
- 2016P001071
- Conditions
- Hyperhidrosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Collaboration with company that made the laser did not proceed.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Sciton
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 26 Nov 2019 (actual)
- Results
- Posted 26 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study involves a single group of patients with Hyperhidrosis. Left and right palms are randomized for treatment versus control (untreated).
| Arm | Type | Receives |
|---|---|---|
| Treated side | Experimental | Device: Laser treatmentTwo test sites are chosen on the palms and randomized to treatment or control sides. Treatment side receives laser treatment of the sweat glands. |
| Untreated side | No intervention | –Two test sites are chosen on the palms and randomized to treatment or control sides. The control side is untreated. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects of ages between 18 and 65 years.
- Subjects with any Fitzpatrick skin type.
- Subjects who are proficient in the English language.
- Willingness to participate in the study.
- Willingness to undergo experimental procedure.
Key exclusion criteria (12 listed)
- Pregnancy
- Subjects on systemic treatment for hyperhidrosis, such as anticholinergic drugs (e.g. glycopyrrolate), sedatives or tranquilizers, within the past 8 weeks.
- Subjects who have undergone surgical excision of sweat glands or sympathectomy for hyperhidrosis.
- 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
- Subjects with a history of coronary artery disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser treatmentIontophoresis 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. | Device | Treated side |
Primary outcome
Gravimetric Measurements of Changes in Sweat Production
Time frame: Assessed at baseline, week 1, week 2, week 4, month 3, and month 6
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Hyperhidrosis
RecruitingObservational study
Targeting Nociceptors in Hidradenitis Suppurativa
Hidradenitis Suppurativa, Hyperhidrosis
Not yet recruiting
20% Alcohol With Steroid Local Anesthetic Technique Versus Steroid Local Anesthetic Technique Only in Stellate Ganglion Injection in Idiopathic Palmar Hyperhydrosis
Hyperhidrosis
Recruiting
Botulinum Toxin Type A for Frontal Hyperhidrosis
Primary Frontal Hyperhidrosis
Not yet recruitingObservational study
"Incidence of Compensatory Hyperhidrosis After T3 Vs T3-4 Sympathectomy"
Compensatory Hyperhidrosis, Compensatory Sweating
Recruiting
A Polymer Film Device to Treat Excessive Palmar Sweating
Palmar Hyperhidrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser treatment in people with Hyperhidrosis, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gravimetric Measurements of Changes in Sweat Production (time frame: Assessed at baseline, week 1, week 2, week 4, month 3, and month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.