Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis

NCT ID: NCT04178161

Last Updated: 2019-11-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2022-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Laser treatment

Intervention Type: 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.

Untreated side

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

Control side is untreated.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sciton

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Richard Rox Anderson, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

R Rox Anderson, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital - Wellman Center for Photomedicine

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Yakir Levin, MD, PhD

Role: CONTACT

ylevin2@partners.org

617-726-3827

Facility Contacts

Kimberli Bell

Role: primary

kbell2@partners.org

617-724-4937

Fernanda H Sakamoto, MD, PhD, MD, PhD

Role: backup

fsakamoto@partners.org

Other Identifiers

2016P001071

Identifier Type: -

Identifier Source: org_study_id