Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis

Last updated: November 25, 2019
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Excessive Sweating

Treatment

N/A

Clinical Study ID

NCT04178161
2016P001071
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 thestudy 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 ofeliciting sweat.

  11. No known allergy to iodine or potato starch

Exclusion

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 forhyperhidrosis.

  4. Subjects with an underlying disorder, such as neurologic injury or disease affectingthe 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 pointof eliciting sweat.

  12. Known allergy to iodine or potato starch.

Study Design

Total Participants: 15
Study Start date:
September 01, 2016
Estimated Completion Date:
August 31, 2022

Connect with a study center

  • Massachusetts General Hospital - Wellman Center for Photomedicine

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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