Patient Satisfaction and Safety of Miradry Treatment for Axillary Hyperhidrosis

NCT ID: NCT04546438

Last Updated: 2023-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-04
• Study Completion Date: 2023-12-01

Brief 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.

Detailed 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.

Conditions

Axillary Hyperhidrosis

Keywords

hyperhidrosis; hyperhidrosis disease severity scale (HDSS); Hospital Anxiety and Depression Scale (HADS); DLQI; HYPERHIDROSIS QUALITY OF LIFE INDEX (HidroQoL); microwave

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MiraDry® treatment

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.

Group Type: EXPERIMENTAL

miraDry®

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Östergötland

OTHER

Sponsor Role: lead

Responsible Party

Emanuela Micu

Principal investigator, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emanuela Micu, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Region Östergötland

Locations

Vrinnevisjukhuset

Norrköping, , Sweden

Countries

Sweden

Other Identifiers

FORSS-932159

Identifier Type: -

Identifier Source: org_study_id