Miradry Treatment for Focal Axillary Hyperhidrosis
Stopped: The study was inactive and no continuing review was submitted, resulting in its expiration and termination
United States31 participantsStarted 2014-11
Plain-language 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.
Who can participate
Age range
18 Years – 29 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ant…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Disease Severity as Assessed by the Hyperhidrosis Disease Severity Scale (HDSS)
Timeframe: Baseline, 6 months, 1 Year
2
Quality of Life as Assessed by the Dermatology Quality of Life Index
Timeframe: Baseline, 6 months, 1 Year
3
Social Phobia as Assessed by the Social Phobia Inventory (SPIN)
Timeframe: Baseline, 6 months, 1 Year
4
Anxiety as Assessed by the Zung Self-rating Anxiety Scale (ASL)
Timeframe: Baseline, 6 months, 1 Year
5
Functioning as Assessed by the Achenbach Self Report (ASR)