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Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis

Primary Purpose

Hyperhidrosis

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Laser treatment

About this trial

This is an interventional treatment trial for Hyperhidrosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Massachusetts General Hospital - Wellman Center for PhotomedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treated side

Untreated side

Arm Description

Two regions are designated on the upper back. Randomized to treatment and control sides. Treatment side receives laser treatment of the sweat glands.

Two regions are designated on the upper back. Randomized to treatment and control sides. Control side is untreated.

Outcomes

Primary Outcome Measures

Measurement of changes in sweat production using gravimetric method

Compare treated side to control side

Secondary Outcome Measures

Full Information

NCT ID

NCT04178161

First Posted

September 17, 2019

Last Updated

November 25, 2019

Sponsor

Massachusetts General Hospital

Collaborators

Sciton

1. Study Identification

Unique Protocol Identification Number

NCT04178161

Brief Title

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

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 2016 (Actual)

Primary Completion Date

August 2022 (Anticipated)

Study Completion Date

August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

Sciton

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperhidrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treated side

Arm Type

Experimental

Arm Description

Two regions are designated on the upper back. Randomized to treatment and control sides. Treatment side receives laser treatment of the sweat glands.

Arm Title

Untreated side

Arm Type

No Intervention

Arm Description

Two regions are designated on the upper back. Randomized to treatment and control sides. Control side is untreated.

Intervention Type

Device

Intervention Name(s)

Laser treatment

Intervention Description

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.

Primary Outcome Measure Information:

Title

Measurement of changes in sweat production using gravimetric method

Description

Compare treated side to control side

Time Frame

Measured at multiple time points, last at 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yakir Levin, MD, PhD

Phone

617-726-3827

ylevin2@partners.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

R Rox Anderson, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital - Wellman Center for Photomedicine

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kimberli Bell

Phone

617-724-4937

kbell2@partners.org

First Name & Middle Initial & Last Name & Degree

Fernanda H Sakamoto, MD, PhD, MD, PhD

fsakamoto@partners.org

First Name & Middle Initial & Last Name & Degree

R. Rox Anderson, MD

First Name & Middle Initial & Last Name & Degree

Fernanda H Sakamoto, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis

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