Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis (NCT04178161) | Clinical Trial Compass
TerminatedNot Applicable
Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis
Stopped: Collaboration with company that made the laser did not proceed.
United States2 participantsStarted 2016-09-01
Plain-language 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. 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Gravimetric Measurements of Changes in Sweat Production
Timeframe: Assessed at baseline, week 1, week 2, week 4, month 3, and month 6
. 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
. Subjects taking SSRIs, SNRIs, TCAs, or MAOIs
. Subjects with known hypersensitivity to methylene blue