Clinical Evaluation of the miraDry System in Subjects With Hyperhidrosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Miramar Labs
ClinicalTrials.gov Identifier:
NCT01091129
First received: March 19, 2010
Last updated: December 5, 2014
Last verified: December 2014
  Purpose

The purpose of this study is to determine whether treatment by the miraDry System can safely reduce the severity of axillary hyperhidrosis (excessive underarm sweating).


Condition Intervention
Axillary Hyperhidrosis
Device: miraDry System (treatment with energy)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the miraDry System in Subjects With Hyperhidrosis

Further study details as provided by Miramar Labs:

Primary Outcome Measures:
  • The proportion of subjects that rate themselves as HDSS of 1 or 2 at the 30 day follow-up visit will be greater than 50% with a 95% confidence. [ Time Frame: 30 days after final treatment session ] [ Designated as safety issue: No ]
  • Rate of serious adverse events [ Time Frame: 12 months post treatment ] [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: February 2010
Study Completion Date: January 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Treatment with the miraDry System in both axilla
Device: miraDry System (treatment with energy)
Treatment with microwave energy delivery device as specified by manufacturer's instructions
Other Name: miraDry System

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is 18 years of age or older at the time of consent.
  • Subject reports a quality-of-life rating of 3 or 4 on the Hyperhidrosis Disease Severity Scale.
  • Subject has a baseline gravimetric measurement of spontaneous resting sweat production of at least 50mg/5min at room temperature in each axilla.
  • Subject has primary focal axillary hyperhidrosis evidenced by at least two of the following:

    • Bilateral and relatively symmetric
    • Impairs daily activities
    • Frequency of at least one episode per week
    • Age of onset less than 25 years old
    • Positive family history
    • Cessation of focal sweating during sleep.
  • In the opinion of the physician, treatment with the miraDry System is technically feasible and clinically indicated.
  • Subject has provided written informed consent using a form that has been approved by the reviewing IRB/ethics committee.
  • Subject is willing and able to comply with protocol requirements and all study visits.
  • Female subjects of child-bearing potential must not be pregnant or lactating and must agree to not become pregnant during the course of the study.

Exclusion Criteria:

  • Subject has secondary hyperhidrosis due to medications, infections, malignancy or endocrinopathy.
  • Subject has hyperhidrosis on the trunk or chest.
  • Subject has evidence of active infection.
  • Prior endoscopic thoracic sympathectomy, liposuction or other surgery for axillary hyperhidrosis.
  • Axillary injection of botulinum toxin within one year preceding the miraDry treatment.
  • Oral anticholinergic medication use (e.g., Robinul) or cholomimetic medication use within the last 4 weeks or planned use during the study's follow up phase.
  • Subject is a prisoner or under incarceration.
  • Currently participating in or recently participated in another clinical trial (within the last 30 days).
  • History of or current neurologic deficit in the treatment limb.
  • Known resistance to or history of difficulty with local anesthesia (lidocaine with epinephrine).
  • History of cancer with the exception of (1) successfully treated basal cell or squamous cell carcinoma of the skin or (2) subjects with a history of successfully treated cancer that have been disease-free for five years.
  • Injury in the treatment area, shoulder or limb, which, in the opinion of the physician would render this subject an unacceptable candidate for DTS treatment (e.g., prior surgical repair, injury of the shoulder requiring physical therapy).
  • Subject has a pacemaker, defibrillator or other electronic implant
  • Subject requires supplemental oxygen.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01091129

Locations
Canada, British Columbia
Guildford Dermatology Specialists
Surrey, British Columbia, Canada, V3R 6A7
Cosmedica
Victoria, British Columbia, Canada, V8R 6V4
Sponsors and Collaborators
Miramar Labs
Investigators
Principal Investigator: Chih-ho Hong, MD Guildford Dermatology Specialists
  More Information

No publications provided

Responsible Party: Miramar Labs
ClinicalTrials.gov Identifier: NCT01091129     History of Changes
Other Study ID Numbers: CP-0004
Study First Received: March 19, 2010
Last Updated: December 5, 2014
Health Authority: Canada: Health Canada

Keywords provided by Miramar Labs:
hyperhidrosis

Additional relevant MeSH terms:
Hyperhidrosis
Skin Diseases
Sweat Gland Diseases

ClinicalTrials.gov processed this record on May 21, 2015