Clinical trial NCT04178161: Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis
Official title: Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperhidrosis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Sciton
First posted: 2019-11-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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

Brief 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.


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.

Primary outcomes:
measure: Measurement of changes in sweat production using gravimetric method
timeFrame: Measured at multiple time points, last at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital - Wellman Center for Photomedicine
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: R Rox Anderson, MD
role: PRINCIPAL_INVESTIGATOR
References: