NCT01091129

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

December 9, 2014

Status Verified

December 1, 2014

Enrollment Period

11 months

First QC Date

March 19, 2010

Last Update Submit

December 5, 2014

Conditions

Axillary Hyperhidrosis

Keywords

hyperhidrosis

Outcome Measures

Primary Outcomes (2)

  • 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.

    30 days after final treatment session

  • Rate of serious adverse events

    12 months post treatment

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment with the miraDry System in both axilla

Device: miraDry System (treatment with energy)

Interventions

miraDry System (treatment with energy)DEVICE

Treatment with microwave energy delivery device as specified by manufacturer's instructions

Also known as: miraDry System
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Guildford Dermatology Specialists

Surrey, British Columbia, V3R 6A7, Canada

Location

Cosmedica

Victoria, British Columbia, V8R 6V4, Canada

Location

MeSH Terms

Conditions

Hyperhidrosis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Sweat Gland DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Chih-ho Hong, MD

    Guildford Dermatology Specialists

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2010

First Posted

March 23, 2010

Study Start

February 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2012

Last Updated

December 9, 2014

Record last verified: 2014-12

Locations

CA(2)