Axillary HyperhidrosisMiraDry TxNCT02295891
Miradry Treatment for Focal Axillary Hyperhidrosis
A study testing MiraDry ® in people with Axillary Hyperhidrosis, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Axillary Hyperhidrosis
- What is being tested?
- MiraDry ®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microwave Energy-induced Thermolysis of Axillary Apocrine Glands and Hair Follicles Will Result in Improvement of Secondary Psychopathology Related to Hyperhidrosis.
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.
Read the 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.
- Conditions
- Axillary Hyperhidrosis
- Being tested
- MiraDry ®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiraDry ®Device
Non-invasive thermolytic technology which utilizes a microwave energy-based mechanism targeted for eccrine gland reduction at the dermal-fat interface
| Study group | Role | What they receive |
|---|---|---|
| MiraDry ® treatment | Experimental | 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. Receives: Device: MiraDry ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 months, 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2019
- Study completionDec 2019
Why it stopped: The study was inactive and no continuing review was submitted, resulting in its expiration and termination
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Axillary HyperhidrosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malcolm Brock, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295891
- Sponsor's protocol ID
- IRB00036743
- Acronym
- MiraDry Tx
- Status last verified
- May 2025
- First submitted
- 17 Nov 2014
- Last updated
- 30 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microwave Energy-induced Thermolysis of Axillary Apocrine Glands and Hair Follicles Will Result in Improvement of Secondary Psychopathology Related to Hyperhidrosis.
- ClinicalTrials.gov ID
- NCT02295891
- Acronym / sponsor ID
- MiraDry Tx / IRB00036743
- Conditions
- Axillary Hyperhidrosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was inactive and no continuing review was submitted, resulting in its expiration and termination
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Posted 30 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MiraDry ® treatment | Experimental | Device: MiraDry ®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. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiraDry ®Non-invasive thermolytic technology which utilizes a microwave energy-based mechanism targeted for eccrine gland reduction at the dermal-fat interface | Device | MiraDry ® treatment |
Primary outcome
Disease Severity as Assessed by the Hyperhidrosis Disease Severity Scale (HDSS)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malcolm Brock, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MiraDry ® in people with Axillary Hyperhidrosis, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Severity as Assessed by the Hyperhidrosis Disease Severity Scale (HDSS) (time frame: Baseline, 6 months, 1 Year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.