NCT02295891

Miradry Treatment for Focal Axillary Hyperhidrosis

Microwave Energy-induced Thermolysis of Axillary Apocrine Glands and Hair Follicles Will Result in Improvement of Secondary Psychopathology Related to Hyperhidrosis.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 29 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objective: 1. To evaluate the effectiveness of the miraDry ® treatment system for psychosocial functioning in patients heavily affected by axillary hyperhidrosis. Secondary Objectives: 2. To characterize the outcomes of and clinical response to the MiraDry ® treatment system with respect to the aforementioned criteria. 3. To compare the results of non-invasive miraDry ® treatment system to the existing surgical correction with respect to the aforementioned criteria.

Conditions

• Axillary Hyperhidrosis

Interventions

Type	Name	Description
DEVICE	MiraDry ®	Non-invasive thermolytic technology which utilizes a microwave energy-based mechanism targeted for eccrine gland reduction at the dermal-fat interface

Timeline

• Start date: 2014-11-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2014-11-20
• Last updated: 2025-05-30
• Results posted: 2025-05-30

Locations

1 site across 1 country: United States