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Patient Satisfaction and Safety of Miradry Treatment for Axillary Hyperhidrosis

NCT04546438 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-12-29

No results posted yet for this study

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.

Conditions

  • Axillary Hyperhidrosis

Interventions

DEVICE

miraDry®

MiraDry is a noninvasive method that uses microwave technology to destroy sweat glands. In this study we evaluate a higher energy level with a newer generation device, in respect with side effects and number of treatments (one or two interventions).

Sponsors & Collaborators

  • Region Östergötland

    lead OTHER

Principal Investigators

  • Emanuela Micu, MD PhD · Region Östergötland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-04
Primary Completion
2023-12-01
Completion
2023-12-01
FDA Device
Yes

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04546438 on ClinicalTrials.gov