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Clinical Trial Summary

Primary localized hyperhidrosis is a dermatological disorder that involves excessive sweat production without an underlying cause. The disease usually affects the axillae but can also involve palms, soles of the feet or face and causes major problems in many social situations with a negative impact on quality of life and mental health. In this study, the investigators want to investigate the effect of microwave therapy (MiraDry®) on self-rated sweating, quality of life and anxiety in participants with severe axillary hyperhidrosis. The study also aims to evaluate the safety (side effects) of the method and long term effects over 1 year of follow upp.

Clinical Trial Description

The study is conducted during several visits or telephone follow-ups at the clinic over a period of 12 months and each patient receives a maximum of two treatments with MiraDry® (at 3-month intervals). 100 participants are planned to participate in the study. The primary objective is to evaluate the effectiveness of the miraDry ® treatment measured by Hyperhidrosis Disease Severity Scale(HDSS). Secondary objectives are to evaluate the side effects and the quality of Life by assessment of The Dermatology life Quality Index, The Hyperhidrosis Quality of Life Index, and Hospital Anxiety and Depression Scale. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04546438
Study type Interventional
Source Region Östergötland
Status Completed
Phase N/A
Start date September 4, 2020
Completion date December 1, 2023

See also
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Completed NCT03948646 - Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302) Phase 3
Completed NCT01274611 - Botox and Suction-Curettage for Treatment of Excessive Underarm Sweating (Axillary Hyperhidrosis) N/A
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Completed NCT00735293 - VASER Treatment of Axillary Hyperhidrosis/Bromidrosis Phase 4