What side effects are associated with this type of intervention?

Common treatments for excessive underarm sweating include botulinum toxin injections, suction curettage, and oral medications such as oxybutynin and glycopyrrolate. Botulinum toxin injections can cause temporary pain at the injection site, muscle weakness, and in rare cases, antibody-induced treatment failure. Suction curettage may result in post-treatment soreness, potential for skipped areas, compensatory sweating, and recurrence due to reinnervation of sweat glands. Oral medications like oxybutynin and glycopyrrolate can cause dry mouth, blurred vision, urinary retention, and constipation. These side effects should be discussed with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

FDA-approved treatments for excessive underarm sweating primarily include botulinum toxin injections (e.g., Botox), which temporarily block the nerves that cause sweating, and topical anticholinergics like glycopyrronium tosylate (Qbrexza). While these treatments focus on the physiological aspects of hyperhidrosis, Cognitive Behavioral Therapy (CBT) addresses the psychological impact by helping patients manage anxiety and improve coping strategies. Although CBT itself is not FDA-approved specifically for hyperhidrosis, it can be a valuable complementary approach to reduce the psychosocial burden associated with the condition.

What other types of research exist?

Promising novel alternatives to CBT for treating excessive underarm sweating include: 1) Botulinum toxin injections, which have shown significant efficacy in reducing sweat production. 2) Suction curettage, a surgical option that aims for permanent removal of sweat glands. 3) Topical glycopyrrolate, which has been effective in reducing sweating with minimal side effects. These treatments offer different mechanisms of action compared to CBT and may provide substantial relief for patients.

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MiraDry® for Excessive Underarm Sweating (MiraDry Tx Trial)

N/A

Waitlist Available

Led By Malcolm Brock, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

This study will recruit patients diagnosed with focal hyperhidrosis with a known diagnosis of primarily axillary localization.

Patients diagnosed with focal hyperhidrosis with primarily axillary localization

Must not have

Patients needing supplemental oxygen

Patients unable to take oral antibiotics or antiseptic washes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of the Miradry Treatment may include temporary swelling, pain at the treatment site, numbness in the underarm or upper arm skin which typically resolves over time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

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I have excessive sweating mainly under my arms.

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I rate my condition as severe or very severe on the HDSS scale.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I need extra oxygen.

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I cannot take oral antibiotics or use antiseptic washes.

Select...

I am unable to understand and give consent for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary effectiveness of the MiraDry treatment system (Hyperhidrosis Disease Severity Scale (HDSS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: MiraDry ® treatmentExperimental Treatment1 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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Botulinum toxin injections work by blocking the nerve signals responsible for activating sweat glands, thereby reducing sweat production. Suction curettage involves the surgical removal of sweat glands, aiming for a more permanent reduction in sweating. Microwave thermolysis uses microwave energy to destroy sweat glands, leading to decreased sweat production. These treatments are significant for patients with excessive underarm sweating as they target the underlying mechanisms of sweat production, offering potential relief from the social and psychological impacts of the condition.

Metacognitive Therapy Versus Cognitive Behavioral Therapy:A Network Approach.