Patient Satisfaction and Safety of Miradry Treatment for Axillary Hyperhidrosis

Region Östergötland

Status: Completed

Conditions: Axillary Hyperhidrosis

Treatments: Device: miraDry®

Study type: Interventional

Funder types: Other

Identifiers

NCT04546438

FORSS-932159

Details and patient eligibility

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Exclusion criteria

Participants

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

MiraDry® treatment

Experimental group

Description:

The miraDry System is a noninvasive method that utilizes microwave energy to destroy the sweat glands at the dermal-fat interface. Each participant will be scheduled one MiraDry ® treatment with the possiblity of a second intervention approximately three months apart if the primary objective is not fullfilled efter the first.

Treatment:

Device: miraDry®