An interventional study of MiraDry ® in Axillary Hyperhidrosis, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to participants aged 18 Years to 29 Years. Per ClinicalTrials.gov, last updated 2025-05-30.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
Primary Objective:
To evaluate the effectiveness of the miraDry ® treatment system for psychosocial functioning in patients heavily affected by axillary hyperhidrosis.
Secondary Objectives:
111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.
This study's enrollment of 31 is below the median of 50 across 99 interventional studies indexed under Hyperhidrosis.
Browse Hyperhidrosis studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
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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 , 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Disease Severity as Assessed by the 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). 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.
Time frame: Baseline, 6 months, 1 Year
Quality of Life as Assessed by the Dermatology Quality of Life Index
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
Time frame: Baseline, 6 months, 1 Year
Social Phobia as Assessed by the Social Phobia Inventory (SPIN)
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.
Time frame: Baseline, 6 months, 1 Year
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.
Time frame: Baseline, 6 months, 1 Year
Functioning as Assessed by the Achenbach Self Report (ASR)
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.
Time frame: Baseline, 6 months, 1 Year
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.
| Milestone | MiraDry ® Treatment Group |
|---|---|
| Started | 24 |
| Completed | 24 |
| Not completed | 0 |
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.
| score on a scale | MiraDry ® Treatment |
|---|---|
| Baseline | 3.46 ± 0.51 |
| 6 months | 2.5 ± .96 |
| 1 year | 2.05 ± .83 |
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
| score on a scale | MiraDry ® Treatment |
|---|---|
| Baseline | 12.92 ± 5.47 |
| 6 months | 6.25 ± 5.74 |
| 1 year | 3.68 ± 4.31 |
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.
| score on a scale | MiraDry ® Treatment |
|---|---|
| Baseline | 28.83 ± 12.04 |
| 6 months | 17.91 ± 14.34 |
| 1 year | 15.90 ± 11.87 |
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.
| score on a scale | MiraDry ® Treatment |
|---|---|
| Baseline | 45.67 ± 10.22 |
| 6 months | 30.96 ± 7.64 |
| 1 year | 27.50 ± 11.87 |
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.
| score on a scale | MiraDry ® Treatment |
|---|---|
| Baseline | 61.38 ± 12.68 |
| 6 months | 53.75 ± 5.34 |
| 1 year | 53.35 ± 4.29 |
Collected over Up to 24 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MiraDry ® Treatment Group | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
Data collected for participants who had at least 1 psychological evaluation and 1 MiraDry treatment appointment
| Age, Customized(Participants) | MiraDry ® Treatment Group |
|---|---|
| 18 to 29 | 24 |
| Sex: Female, Male(Participants) | MiraDry ® Treatment Group |
|---|---|
| Female | 13 |
| Male | 11 |
| Ethnicity (NIH/OMB)(Participants) | MiraDry ® Treatment Group |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 23 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | MiraDry ® Treatment Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 19 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| hyperhidrosis in primarily axillary localization(Participants) | MiraDry ® Treatment Group |
|---|---|
| Count of participants | 24 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Nov 2014 to primary completion in Dec 2019, 61 months.
Results were first posted in May 2025, 5 years 5 months after primary completion.
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