MiraDry® for Excessive Underarm Sweating

(MiraDry Tx Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Allergies, Pregnancy, Pacemakers, Oxygen, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests MiraDry, a non-invasive treatment using microwave energy to reduce sweat glands, for individuals struggling with excessive underarm sweating. The goal is to evaluate MiraDry's effectiveness in reducing sweat and improving the social and emotional challenges associated with this condition. It suits those experiencing noticeable underarm sweating that disrupts daily life. Participants should have a diagnosis of this issue and be available for two treatment sessions. As an unphased trial, this study provides a unique opportunity to explore a promising treatment option for enhancing quality of life.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it mentions that previous treatments, including psychiatric medications, won't exclude you from participating.

What prior data suggests that the MiraDry® treatment is safe for excessive underarm sweating?

Research has shown that MiraDry is a safe and effective treatment for excessive underarm sweating. MiraDry uses microwave energy to target and reduce sweat glands, and studies indicate that patients generally tolerate it well. The U.S. FDA approved it in 2011 for treating underarm sweating, supporting its safety.

Reports highlight that MiraDry can greatly improve quality of life by reducing sweat and odor without affecting other body areas. Some people might experience minor side effects like swelling or redness, but these usually resolve on their own. Overall, MiraDry has a strong safety record, making it a promising option for those dealing with excessive sweating. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MiraDry for excessive underarm sweating because it uses a unique non-invasive method to tackle the problem. Unlike traditional treatments like topical antiperspirants or Botox injections, which temporarily block sweat glands, MiraDry employs microwave energy to permanently reduce the number of sweat glands. This thermolytic technology precisely targets glands at the dermal-fat interface, offering a long-lasting solution. Additionally, it requires only two treatment sessions spaced three months apart, which is less frequent than ongoing topical applications or injections.

What evidence suggests that MiraDry is effective for excessive underarm sweating?

Research shows that MiraDry, the treatment under study in this trial, effectively reduces excessive underarm sweating. Studies have found that over 90% of patients experience a noticeable decrease in sweat after treatment. On average, patients see an 82% reduction in sweating, with results lasting more than two years. This non-invasive option uses microwave energy to target sweat glands, offering a more convenient alternative to traditional treatments. Patients also report a significant improvement in their quality of life after using MiraDry. ^{1 2 6 7 8}

Who Is on the Research Team?

Malcolm Brock, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-29 with severe underarm sweating, rated 3 or higher on the Hyperhidrosis Disease Severity Scale. It's open to those who've tried non-invasive treatments before. Excluded are pregnant individuals, those unable to take oral antibiotics or use antiseptic washes, patients needing supplemental oxygen, with pacemakers/electronic implants, or allergies to lidocaine/hibiclens/epinephrine.

Inclusion Criteria

I have been diagnosed with excessive sweating, mainly under my arms.

I have excessive sweating mainly under my arms.

Everyone will be evaluated using a scale to measure how severe their hyperhidrosis is.

Exclusion Criteria

I need extra oxygen.

I am unable to understand and give consent for treatment.

Patients with heart pacemakers or other electronic device implants

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two MiraDry treatment appointments approximately three months apart

3 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment using the HDSS

1 year

2 visits (in-person) at 6 months and 1 year

What Are the Treatments Tested in This Trial?

Interventions

• MiraDry

Trial Overview The Miradry Treatment is being tested in this study. This treatment targets excessive underarm sweating (axillary hyperhidrosis). The goal is to understand how effectively it reduces sweat and improves related psychosocial issues like anxiety and social avoidance.

How Is the Trial Designed?

Group I: MiraDry ® treatment Experimental Treatment 1 Intervention

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 Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

The study presents a novel approach combining the starch-iodine technique with tumescent liposuction to effectively treat axillary hyperhidrosis, a condition characterized by excessive sweating in the armpits.

This method is highlighted as both safe and effective, offering a permanent solution compared to traditional treatments that often have significant drawbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of axillary hyperhidrosis: combination of the starch-iodine test with the tumescent liposuction technique. Swinehart, JM.[2019]

In a study involving 31 adults with primary axillary hyperhidrosis, a microwave-based device effectively reduced sweating, with 90.3% of participants reporting significant improvements in sweat severity and quality of life after 12 months.

While the treatment was generally safe, with transient side effects like swelling and altered sensation, all adverse effects resolved, indicating a favorable safety profile for the device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a microwave device for treating axillary hyperhidrosis. Hong, HC., Lupin, M., O'Shaughnessy, KF.[2022]

Citations

1. sweathelp.org sweathelp.org/hyperhidrosis-treatments/miradry.html

miraDry® - International Hyperhidrosis Society | Official Site In April 2012, clinical data from the University of British Columbia showed that miraDry was successful in reducing underarm sweat in over 90% of patients. The ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11570828/

Patient satisfaction after miraDry® treatment for axillary ... miraDry is an effective alternative to traditional hyperhidrosis therapies. It offers the advantage of a non-invasive treatment with a high success rate.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39753871/

Evaluation of Efficacy and Safety of miraDry® Procedure in ... miraDry procedure is an effective and safe treatment option for primary axillary hyperhidrosis, which results in an immense improvement in quality of life.

4. sweathelp.org sweathelp.org/pdf/Wimmer%202025%20-%20Evaluation%20of%20efficacy%20and%20safety%20of%20miradry%20procedure%20in%20the%20treatment%20of%20primary%20axillary%20hh.pdf

Evaluation of Efficacy and Safety of miraDry® Procedure in ... The mira-. Dry® procedure demonstrated a favorable safety profile with typical and transient treatment reactions that mostly resolved within 6 months (94.2%).

5. worcesterderm.com worcesterderm.com/how-effective-are-the-treatments-for-hyperhidrosis/

How Effective Are the Treatments for Hyperhidrosis? Clinical studies show an 82% average reduction in underarm sweating and most patients maintaining results beyond two years. This treatment is currently only ...

6. sweathelp.org sweathelp.org/treatments-hcp/miradry.html

miraDry® - International Hyperhidrosis Society | Official Site "Histology data show sweat gland necrosis at 11 days post treatment and reduction of sweat glands 6 months after treatment. Further follow-up on these patients ...

7. miradry.com miradry.com/excessive-sweat/

Excessive Sweat Indications for Use: The miraDry system is FDA-cleared for the treatment of unwanted underarm sweat and odor, as well as the permanent removal of unwanted ...

8. defineclinic.com defineclinic.com/how-safe-is-miradry/

How Safe is miraDry Sweating Treatment? So, while the miraDry leaves the underarms sweat-free, perspiration across the rest of the body is unaffected and the procedure is shown to have no effect on ...