Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis

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 Overview

• Status: Unknown
• Conditions: Hyperhidrosis
• Intervention / Treatment: Device: Laser treatment

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yakir Levin, MD, PhD; Phone Number: 617-726-3827; Email: ylevin2@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital - Wellman Center for Photomedicine
      • Contact: Kimberli Bell; Phone Number: 617-724-4937; Email: kbell2@partners.org
      • Contact: Fernanda H Sakamoto, MD, PhD, MD, PhD; Email: fsakamoto@partners.org
      • Sub-Investigator: Fernanda H Sakamoto, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Laser treatment; 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.
NO_INTERVENTION: Untreated side; Two regions are designated on the upper back. Randomized to treatment and control sides. Control side is untreated.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Sciton
• Investigators: Principal Investigator: R Rox Anderson, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2016
• Primary Completion (ANTICIPATED): August 1, 2022
• Study Completion (ANTICIPATED): August 1, 2022

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (ACTUAL): November 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 25, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis
• Other Study ID Numbers: 2016P001071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED