Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis

Launched by MASSACHUSETTS GENERAL HOSPITAL · Nov 25, 2019

Keywords

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Gender

ALL

Eligibility criteria

• 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.