Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis
Purpose
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.
Condition
- Hyperhidrosis
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- The study involves a single group of patients with Hyperhidrosis. Left and right palms are randomized for treatment versus control (untreated).
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treated side |
Two regions are designated on the upper back. Randomized to treatment and control sides. Treatment side receives laser treatment of the sweat glands. |
|
|
No Intervention Untreated side |
Two regions are designated on the upper back. Randomized to treatment and control sides. Control side is untreated. |
|
Recruiting Locations
Massachusetts General Hospital - Wellman Center for Photomedicine
Boston, Massachusetts 02114
Boston, Massachusetts 02114
More Details
- Status
- Unknown status
- Sponsor
- Massachusetts General Hospital