Trial Outcomes & Findings for Miradry Treatment for Focal Axillary Hyperhidrosis (NCT NCT02295891)

NCT ID: NCT02295891

Last Updated: 2025-05-30

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 31 participants
• Primary outcome timeframe: Baseline, 6 months, 1 Year
• Results posted on: 2025-05-30

Participant Flow

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.

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

Participant milestones

Measure	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
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Miradry Treatment for Focal Axillary Hyperhidrosis

Baseline characteristics by cohort

Measure	MiraDry ® Treatment Group n=24 Participants 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
Age, Customized 18 to 29	24 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
hyperhidrosis in primarily axillary localization	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 months, 1 Year

Population: Participants with data collected are reported

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.

Outcome measures

Measure	MiraDry ® Treatment n=24 Participants 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
Disease Severity as Assessed by the Hyperhidrosis Disease Severity Scale (HDSS) Baseline	3.46 score on a scale Standard Deviation 0.51
Disease Severity as Assessed by the Hyperhidrosis Disease Severity Scale (HDSS) 6 months	2.5 score on a scale Standard Deviation .96
Disease Severity as Assessed by the Hyperhidrosis Disease Severity Scale (HDSS) 1 year	2.05 score on a scale Standard Deviation .83

PRIMARY outcome

Timeframe: Baseline, 6 months, 1 Year

Population: Participants with data collected are reported

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

Outcome measures

Measure	MiraDry ® Treatment n=24 Participants 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
Quality of Life as Assessed by the Dermatology Quality of Life Index Baseline	12.92 score on a scale Standard Deviation 5.47
Quality of Life as Assessed by the Dermatology Quality of Life Index 6 months	6.25 score on a scale Standard Deviation 5.74
Quality of Life as Assessed by the Dermatology Quality of Life Index 1 year	3.68 score on a scale Standard Deviation 4.31

PRIMARY outcome

Timeframe: Baseline, 6 months, 1 Year

Population: Participants with data collected are reported.

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.

Outcome measures

Measure	MiraDry ® Treatment n=24 Participants 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
Social Phobia as Assessed by the Social Phobia Inventory (SPIN) Baseline	28.83 score on a scale Standard Deviation 12.04
Social Phobia as Assessed by the Social Phobia Inventory (SPIN) 6 months	17.91 score on a scale Standard Deviation 14.34
Social Phobia as Assessed by the Social Phobia Inventory (SPIN) 1 year	15.90 score on a scale Standard Deviation 11.87

PRIMARY outcome

Timeframe: Baseline, 6 months, 1 Year

Population: Participants with data collected are reported

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.

Outcome measures

Measure	MiraDry ® Treatment n=24 Participants 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
Anxiety as Assessed by the Zung Self-rating Anxiety Scale (ASL) Baseline	45.67 score on a scale Standard Deviation 10.22
Anxiety as Assessed by the Zung Self-rating Anxiety Scale (ASL) 6 months	30.96 score on a scale Standard Deviation 7.64
Anxiety as Assessed by the Zung Self-rating Anxiety Scale (ASL) 1 year	27.50 score on a scale Standard Deviation 11.87

PRIMARY outcome

Timeframe: Baseline, 6 months, 1 Year

Population: Participants with data collected are reported

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.

Outcome measures

Measure	MiraDry ® Treatment n=24 Participants 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
Functioning as Assessed by the Achenbach Self Report (ASR) Baseline	61.38 score on a scale Standard Deviation 12.68
Functioning as Assessed by the Achenbach Self Report (ASR) 6 months	53.75 score on a scale Standard Deviation 5.34
Functioning as Assessed by the Achenbach Self Report (ASR) 1 year	53.35 score on a scale Standard Deviation 4.29

Adverse Events

MiraDry ® Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kristen Rodgers- Research Program Manager, Dept, of Thoracic Surgery

Johns Hopkins University

Phone: 410-955-9047

Email: kpelosk1@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place