Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis

Not Applicable

• Conditions: Hyperhidrosis
• Interventions: Device: Laser treatment

• Registration Number: NCT04178161
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2019-09-17
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-25
• Last Update Submitted: 2019-11-25
• Study First Posted: 2019-11-26
• Last Update Posted: 2019-11-26
• Primary Completion: 2022-08
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Measurement of changes in sweat production using gravimetric method	Measured at multiple time points, last at 6 months	Compare treated side to control side

Trial Locations

Locations (1)

Massachusetts General Hospital - Wellman Center for Photomedicine; 🇺🇸 Boston, Massachusetts, United States