Miradry Treatment for Focal Axillary Hyperhidrosis

Study Overview
=================
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.

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

Conditions
-----------------
Axillary Hyperhidrosis

Intervention / Treatment
-----------------
* Device: MiraDry ®


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MiraDry ® treatment<br>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 ®<br>* Non-invasive thermolytic technology which utilizes a microwave energy-based mechanism targeted for eccrine gland reduction at the dermal-fat interface<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year |