Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis

NCT04178161 | Unknown DMC

• 1 other identifier: 2016P001071
• Study Type: interventional
• Target: 15
• 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)

• Measurement of changes in sweat production using gravimetric method

  Compare treated side to control side

  Measured at multiple time points, last at 6 months

Study Arms (2)

Treated side

EXPERIMENTAL

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

Untreated side

NO INTERVENTION

Two regions are designated on the upper back. Randomized to treatment and control sides. 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

RECRUITING

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

Study Officials

• R Rox Anderson, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yakir Levin, MD, PhD

CONTACT

617-726-3827; ylevin2@partners.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• 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: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: November 26, 2019

Record last verified: 2019-11

Locations

US (1)