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Miradry Treatment for Focal Axillary Hyperhidrosis (MiraDry Tx)

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ClinicalTrials.gov Identifier: NCT02295891
Recruitment Status : Active, not recruiting
First Posted : November 20, 2014
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Axillary Hyperhidrosis Device: MiraDry ® Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Microwave Energy-induced Thermolysis of Axillary Apocrine Glands and Hair Follicles Will Result in Improvement of Secondary Psychopathology Related to Hyperhidrosis.
Study Start Date : November 2014
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Arm Intervention/treatment
Experimental: 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.

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




Primary Outcome Measures :
  1. Primary effectiveness of the MiraDry treatment system (Hyperhidrosis Disease Severity Scale (HDSS) [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295891


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Malcolm Brock, MD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02295891     History of Changes
Other Study ID Numbers: IRB00036743
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases