Patient Satisfaction and Safety of Miradry Treatment for Axillary Hyperhidrosis

NCT04546438 | Completed FDA Device

• 1 other identifier: FORSS-932159
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Axillary Hyperhidrosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The effectiveness of miraDry treatment

  The effect of the treatment will be measured by the participants completing the Hyperhidrosis Disease Severity Scale (score 1 to 4, where a score of 3 or 4 indicates severe hyperhidrosis and a score of 1 or 2 indicates mild or moderate hyperhidrosis) att baseline (prescreening), at 3 month follow-up visit and 1 year follow-up visit.

  1 year

Secondary Outcomes (4)

• Frequency of side effects

  1 year

• Dermatology Life Quality Index assessment

  1 year

• Hospital anxiety and depression scale assessment

  1 year

• Hyperhidrosis Quality of Life Index assessment

  1 year

Study Arms (1)

MiraDry® treatment

EXPERIMENTAL

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.

Device: miraDry®

Interventions

miraDry® 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).

MiraDry® treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Östergötland: lead

Study Sites (1)

Vrinnevisjukhuset

Norrköping, 60379, Sweden

Location

MeSH Terms

Conditions

Hyperhidrosis; Depression

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior

Study Officials

• Emanuela Micu, MD PhD

  Region Östergötland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD, PhD

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: September 14, 2020
• Study Start: September 4, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)