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

31 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of the miraDry® treatment system for improving the social and emotional well-being of patients with severe underarm sweating. miraDry® is a non-surgical procedure that uses heat to eliminate sweat glands in the underarms. The goal is to see if this treatment can help reduce sweating and improve quality of life compared to existing surgical options.

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 data supports the effectiveness of the treatment MiraDry for excessive underarm sweating?

Research shows that a microwave energy device, like MiraDry, can effectively reduce underarm sweating by 61-70% and improve patient satisfaction. Most side effects, such as bruising and pain, resolve within 12 weeks, making it a durable and effective treatment for excessive sweating. ^{1 2 3 4 5}

Is MiraDry safe for treating excessive underarm sweating?

MiraDry, a microwave-based treatment for excessive underarm sweating, is generally safe but can cause side effects like bruising, pain, swelling, numbness, and nodules, which usually resolve within 12 weeks. There is a rare risk of nerve injury, especially in thin individuals, so using low-energy settings and pre-procedural ultrasound is recommended for these patients. ^{2 4 6 7 8}

How does the MiraDry treatment for excessive underarm sweating differ from other treatments?

MiraDry is unique because it uses microwave energy to target and destroy sweat glands in the underarm area, offering a minimally-invasive option compared to topical treatments or oral medications. This approach can provide a more permanent solution to excessive sweating, unlike temporary relief from antiperspirants or medications. ^{3 4 8 9 10}

Research Team

Malcolm Brock, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a microwave device for treating axillary hyperhidrosis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

A survey of long-term results with microwave energy device for treating axillary hyperhidrosis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

PURLs: Oral agent offers relief from generalized hyperhidrosis [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment of focal axillary hyperhidrosis using a long-pulsed Nd:YAG 1064 nm laser at hair reduction settings. [2011]

6. United States pubmed.ncbi.nlm.nih.gov

Topical Treatment of Primary Focal Hyperhidrosis, Part 1. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Long-term efficacy and safety of 1% glycopyrronium bromide cream in patients with severe primary axillary hyperhidrosis: Results from a Phase 3b trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Conservative Management of Median Nerve Brachial Plexopathy after Microwave-based MiraDry Treatment for Axillary Hyperhidrosis. [2021]

9. Sweden pubmed.ncbi.nlm.nih.gov

Axillary hyperhidrosis: local treatment with aluminum chloride hexahydrate 25% in absolute ethanol. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Remission of facial and scalp hyperhidrosis with clonidine hydrochloride and topical aluminum chloride. [2018]