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Miradry Treatment for Focal Axillary Hyperhidrosis (MiraDry Tx)

Primary Purpose

Axillary Hyperhidrosis

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MiraDry ®

About this trial

This is an interventional treatment trial for Axillary Hyperhidrosis

Eligibility Criteria

18 Years - 29 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Johns Hopkins University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MiraDry ® treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Primary effectiveness of the MiraDry treatment system (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) as a prescreening survey. The HDSS (below) is a diagnostic tool that qualitatively measures (Likert scaled 1-4) disease-specific severity of the patient's condition based on the degree to which daily activities are impacted. This will be done at baseline, during treatment, at the 6 month follow-up visit, and 1 year follow-up visit.

Secondary Outcome Measures

Full Information

NCT ID

NCT02295891

First Posted

November 17, 2014

Last Updated

August 29, 2023

Sponsor

Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT02295891

Brief Title

Miradry Treatment for Focal Axillary Hyperhidrosis

Acronym

MiraDry Tx

Official Title

Microwave Energy-induced Thermolysis of Axillary Apocrine Glands and Hair Follicles Will Result in Improvement of Secondary Psychopathology Related to Hyperhidrosis.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 2014 (Actual)

Primary Completion Date

November 2024 (Anticipated)

Study Completion Date

November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

4. Oversight

Data Monitoring Committee

5. Study Description

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: To evaluate the effectiveness of the miraDry ® treatment system for psychosocial functioning in patients heavily affected by axillary hyperhidrosis. Secondary Objectives: To characterize the outcomes of and clinical response to the MiraDry ® treatment system with respect to the aforementioned criteria. To compare the results of non-invasive miraDry ® treatment system to the existing surgical correction with respect to the aforementioned criteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Axillary Hyperhidrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MiraDry ® treatment

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

MiraDry ®

Intervention Description

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

Primary Outcome Measure Information:

Title

Primary effectiveness of the MiraDry treatment system (Hyperhidrosis Disease Severity Scale (HDSS)

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

29 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Malcolm Brock, MD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins University

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Miradry Treatment for Focal Axillary Hyperhidrosis

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