Miradry Treatment for Focal Axillary Hyperhidrosis

NCT02295891 | Terminated Results

• 1 other identifier: IRB00036743
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Primary hyperhidrosis is a pathological condition characterized by the idiopathic and excessive secretion of sweat beyond normal physiological demand and is localized at particular foci such as the face, axilla, palms of the hands, and soles of the feet. Patients seeking medical attention for hyperhidrosis often report disruptions to their professional and/or social lives due to sweating and subsequently experience many psychosocial difficulties, such as anxiety, social phobia, and depression. Therefore, a psychiatric explanation of causality is frequently offered for these patients during diagnosis. Excessive sweating is often mistakenly interpreted as a symptom of an anxiety disorder and can be cause for social embarrassment, exacerbating emotional stress and social avoidance. As currently constituted, the treatment of secondary psychosocial symptoms in primary hyperhidrosis is poorly understood and requires further investigation.

Conditions

Axillary Hyperhidrosis

Outcome Measures

Primary Outcomes (5)

• Disease Severity as Assessed by the Hyperhidrosis Disease Severity Scale (HDSS)

  To evaluate the effectiveness of the miraDry ® treatment system for psychosocial functioning in patients heavily affected by axillary hyperhidrosis. Patients will be asked to complete the Hyperhidrosis Disease Severity Scale (HDSS). HDSS assigns a point value where severity is scored: Minimal (1)=My sweating is never noticeable and never interferes with my daily activities to most severe score is: (4)=My sweating is intolerable and always interferes with my daily activities. Lower point values are considered better and higher point values are considered worse.

  Baseline, 6 months, 1 Year

• Quality of Life as Assessed by the Dermatology Quality of Life Index

  To evaluate the effectiveness of the miraDry ® treatment system for psychosocial functioning in patients heavily affected by axillary hyperhidrosis. Patients will be asked to complete the Dermatology Quality of Life Index. Total score range from 0-30, a higher score indicating more impairment on the participant's quality of life

  Baseline, 6 months, 1 Year

• Social Phobia as Assessed by the Social Phobia Inventory (SPIN)

  To evaluate the effectiveness of the miraDry ® treatment system for psychosocial functioning in patients heavily affected by axillary hyperhidrosis. Patients will be asked to complete the Social Phobia Inventory (SPIN) consisting of 17 questions to assess social phobia. The lowest possible score is 0 and the highest is 68. A score of 19 or more on the SPIN suggests social phobia or social anxiety disorder. A lower score, or reduction in score, is better.

  Baseline, 6 months, 1 Year

• Anxiety as Assessed by the Zung Self-rating Anxiety Scale (ASL)

  To evaluate the effectiveness of the miraDry ® treatment system for psychosocial functioning in patients heavily affected by axillary hyperhidrosis. Patients will be asked to complete the Zung Self-rating Anxiety Scale (ASL). The score range is 20-80: 20-44 Normal Range, 45-59 Mild to Moderate Anxiety Levels, 60-74 Marked to Severe Anxiety Levels, 75-80 Extreme Anxiety Levels.

  Baseline, 6 months, 1 Year

• Functioning as Assessed by the Achenbach Self Report (ASR)

  To evaluate the effectiveness of the MiraDry ® treatment system for psychosocial functioning in patients heavily affected by axillary hyperhidrosis. Patients will be asked to complete the Achenbach Self Report, with a score range of 0 to 240, with score of 65 being marked as concerning. A lower score correlates to better functioning.

  Baseline, 6 months, 1 Year

Study Arms (1)

MiraDry ® treatment

EXPERIMENTAL

MiraDry ® is the trademarked name of a non-invasive thermolytic technology which utilizes a microwave energy-based mechanism targeted for eccrine gland reduction at the dermal-fat interface. Each participant will be scheduled two MiraDry ® treatment appointments approximately three months apart.

Device: MiraDry ®

Interventions

MiraDry ® DEVICE

Non-invasive thermolytic technology which utilizes a microwave energy-based mechanism targeted for eccrine gland reduction at the dermal-fat interface

MiraDry ® treatment

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• This study will recruit patients diagnosed with focal hyperhidrosis with a known diagnosis of primarily axillary localization.
• We will only enroll patients available for both treatment visits. Availability for follow-up visit is optional.
• Only patients between the ages of 18 and 29 years when the first HHIQ is administered will be eligible.
• The upper age limit was so determined because patients over 29 years often present with psychopathology which is far more recalcitrant to correction of any kind regardless of effectiveness because of the duration of the condition.
• The lower age limit was so determined because 18 years and up are the ages for which the miraDry ® procedure has been approved for use by the FDA.
• All participants will be screened using the Hyperhidrosis Disease Severity Scale (HDSS).
• Only patients reporting their condition as a 3 out of 4 or higher on the HDSS will be eligible for study because preliminary data suggests effective detection of psychological changes only at higher reported levels of sweating severity.

You may not qualify if:

• Patients who are unable to provide informed consent, have known allergies to lidocaine, hibiclens with 4% chlorhexidine, and/or epinephrine, are pregnant (as determined by self-reporting), are unable to take oral antibiotics or antiseptic washes, have heart pacemakers or other electronic device implants, and who need supplemental oxygen are not eligible to participate in this study

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Limitations and Caveats

Some patients had issues with the cost of the third round of treatments, if necessary. Sometimes the study team needed to reach out a few times in order to get all questionnaires completed.

Results Point of Contact

• Title: Kristen Rodgers- Research Program Manager, Dept, of Thoracic Surgery
• Organization: Johns Hopkins University

kpelosk1@jhmi.edu

410-955-9047

Study Officials

• Malcolm Brock, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 20, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 30, 2025
• Results First Posted: May 30, 2025

Record last verified: 2025-05

Locations

US (1)