Miradry Treatment for Focal Axillary Hyperhidrosis

NCT ID: NCT02295891

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2019-12-31

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.

Detailed Description

Primary Objective:

1. To evaluate the effectiveness of the miraDry ® treatment system for psychosocial functioning in patients heavily affected by axillary hyperhidrosis.

Secondary Objectives:

2. To characterize the outcomes of and clinical response to the MiraDry ® treatment system with respect to the aforementioned criteria.

3. To compare the results of non-invasive miraDry ® treatment system to the existing surgical correction with respect to the aforementioned criteria.

Conditions

Axillary Hyperhidrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MiraDry ® treatment

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.

Group Type: EXPERIMENTAL

MiraDry ®

Intervention Type: DEVICE

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

Interventions

MiraDry ®

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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.

A patient's previous non-invasive treatment course, including but not limited to prescription of psychiatric medication and topical therapies, will not justify exclusion from this study.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Malcolm Brock, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00036743

Identifier Type: -

Identifier Source: org_study_id