Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis

Study Overview
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Brief Summary
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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.

Official Title
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Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis

Conditions
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Hyperhidrosis

Intervention / Treatment
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* Device: Laser treatment


Participation Criteria
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Eligibility Criteria
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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). 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 Exclusion Criteria: 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treated side<br>Two regions are designated on the upper back. Randomized to treatment and control sides. Treatment side receives laser treatment of the sweat glands. | Device: Laser treatment<br>* 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.<br>|
| No Intervention: Untreated side<br>Two regions are designated on the upper back. Randomized to treatment and control sides. Control side is untreated. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of changes in sweat production using gravimetric method | Compare treated side to control side | Measured at multiple time points, last at 6 months |