Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis

Hyperhidrosis Clinical Trial

Official title:

Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04178161
• Other study ID #: 2016P001071
• Status: Recruiting
• Phase: N/A
• Start date: September 2016
• Est. completion date: August 2022

Study information

• Verified date: November 2019
• Source: Massachusetts General Hospital
• Contact: Yakir Levin, MD, PhD
• Phone: 617-726-3827
• Email: ylevin2[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperhidrosis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital - Wellman Center for Photomedicine	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Sciton

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of changes in sweat production using gravimetric method	Compare treated side to control side	Measured at multiple time points, last at 6 months