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Patient Satisfaction and Safety of Miradry Treatment for Axillary Hyperhidrosis

Sponsored by Region Östergötland

About this trial

Last updated 5 years ago

Study ID

FORSS-932159

Status

Unknown status

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18 to 65 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 3 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

- This study will recruit participants diagnosed with primarily axillary hyperhidrosis

- Informed consent is required.

- HDSS 3 or 4 (the criteria used in Sweden to allow hospital-based intervention).

No

Exclusion Criteria

- who are unable to provide informed consent,

- have known allergies to lidocaine, chlorhexidine, and/or epinephrine,

- are pregnant,

- are unable to take oral antibiotics or antiseptic washes,

- have heart pacemakers or other electronic device implants,

- who need supplemental oxygen,

- have had axillary surgery procedures for hyperhidrosis,

- with previous hidradenitis suppurativa or other local infections

- had previous cancer in the treated area are not eligible to participate in this study

Locations

Location

Status

Recruiting