Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis

Massachusetts General Hospital2 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hyperhidrosis

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Massachusetts General Hospital - Wellman Center for Photomedicine

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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