Miradry Treatment for Focal Axillary Hyperhidrosis

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02295891

Acronym

MiraDry Tx

Enrollment

Registered

2014-11-20

Start date

2014-11-30

Completion date

2019-12-31

Last updated

2025-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Axillary Hyperhidrosis

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.

Interventions

DEVICEMiraDry ®

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 29 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Disease Severity as Assessed by the Hyperhidrosis Disease Severity Scale (HDSS)	Baseline, 6 months, 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). 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.
Quality of Life as Assessed by the Dermatology Quality of Life Index	Baseline, 6 months, 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 Dermatology Quality of Life Index. Total score range from 0-30, a higher score indicating more impairment on the participant's quality of life
Social Phobia as Assessed by the Social Phobia Inventory (SPIN)	Baseline, 6 months, 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 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.
Anxiety as Assessed by the Zung Self-rating Anxiety Scale (ASL)	Baseline, 6 months, 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 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.
Functioning as Assessed by the Achenbach Self Report (ASR)	Baseline, 6 months, 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 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.

Countries

United States

Participant flow

Recruitment details

Participants who have focal hyperhidrosis with a known diagnosis of primarily axillary localization were recruited from both the Johns Hopkins Department of Dermatology and Thoracic Surgery. The recruitment of these patients will occur during normal appointments and clinic visits at Johns Hopkins Hospital.

Pre-assignment details

Total 31 patients signed consents- * 7 of the 31 consented but never scheduled 1st procedure and were not assigned to the arm * 24 patients were assigned to the arm

Participants by arm

Arm	Count
MiraDry ® Treatment Group 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	24
Total	24

Baseline characteristics

Characteristic	MiraDry ® Treatment Group
Age, Customized 18 to 29	24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants
hyperhidrosis in primarily axillary localization	24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	2 Participants
Race (NIH/OMB) Black or African American	1 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants
Race (NIH/OMB) White	19 Participants
Sex: Female, Male Female	13 Participants
Sex: Female, Male Male	11 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 24
other Total, other adverse events	0 / 24
serious Total, serious adverse events	0 / 24

Outcome results

Primary

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.