Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis

NCT04178161 | Terminated Results DMC

• 1 other identifier: 2016P001071
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperhidrosis

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessed at baseline, week 1, week 2, week 4, month 3, and month 6

Study Arms (2)

Treated side

EXPERIMENTAL

Two test sites are chosen on the palms and randomized to treatment or control sides. Treatment side receives laser treatment of the sweat glands.

Device: Laser treatment

Untreated side

NO INTERVENTION

Two test sites are chosen on the palms and randomized to treatment or control sides. The control side is untreated.

Interventions

Laser treatment DEVICE

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.

Treated side

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects of ages between 18 and 65 years.
• Subjects with any Fitzpatrick skin type.
• Subjects who are proficient in the English language.
• Willingness to participate in the study.
• Willingness to undergo experimental procedure.
• Informed consent agreement signed by the subject.
• Willingness to follow the follow-up schedule.
• Willingness not to use any other hyperhidrosis treatment to the tests sites during the study period (i.e. deodorant, at-home iontophoresis, Botox, MiraDry).
• Patient rates symptoms at level "3" or "4" on the hyperhidrosis disease severity scale (HDSS, see below).
• Subject in appropriate physical health to ride a stationary bicycle to the point of eliciting sweat.
• No known allergy to iodine or potato starch

You may not qualify if:

• Pregnancy
• Subjects on systemic treatment for hyperhidrosis, such as anticholinergic drugs (e.g. glycopyrrolate), sedatives or tranquilizers, within the past 8 weeks.
• Subjects who have undergone surgical excision of sweat glands or sympathectomy for hyperhidrosis.
• 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
• Subjects with a history of coronary artery disease.
• Subjects with a history of poor compliance or psychosis
• Subjects taking SSRIs, SNRIs, TCAs, or MAOIs
• Subjects with known hypersensitivity to methylene blue
• Subjects with cardiac pacemaker or any other electrically powered implantable device.
• Subjects not proficient in the English language.
• Subject not in appropriate physical health to ride a stationary bicycle to the point of eliciting sweat.
• Known allergy to iodine or potato starch.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Sciton: collaborator

Study Sites (1)

Massachusetts General Hospital - Wellman Center for Photomedicine

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Hyperhidrosis

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Yakir Levin
• Organization: Massachusetts General hospital

ylevin2@mgh.harvard.edu

6177262914

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study involves a single group of patients with Hyperhidrosis. Left and right palms are randomized for treatment versus control (untreated).

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: November 26, 2019
• Study Start: September 1, 2016
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: June 26, 2026
• Results First Posted: June 26, 2026

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)