Patient Satisfaction and Safety of Miradry Treatment for Axillary Hyperhidrosis

Patient Quality of Life and Safety of Treatment With Microwave Technology for Axillary Hyperhidrosis

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.

Study Overview

• Status: Completed
• Conditions: Axillary Hyperhidrosis
• Intervention / Treatment: Device: miraDry®

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Norrköping, Sweden, 60379
    • Vrinnevisjukhuset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of side effects	Short and long term effects will be assessed during treatment and by follow -up telephone visits 2 weeks after the treatment(s), at 3 month follow-up and 1 year follow-up.	1 year
Dermatology Life Quality Index assessment	The participants will be asked to complete the Dermatology Life Quality Index, calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The paticipants will complete the questionnaire at baseline, at 3 months follow-up visit and 1 year follow-up visit.	1 year
Hospital anxiety and depression scale assessment	The participants will be asked to complete the questionnaire at baseline, at 3 months follow-up visit and 1 year follow-up visit. The questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.	1 year
Hyperhidrosis Quality of Life Index assessment	The participants will be asked to complete the Hyperhidrosis Quality of Life Index at baseline, at 3 months follow-up visit and 1 year follow-up visit. There are 18 items and score ranges from 0 to 36, with higher scores indicating a lower Hyperhidrosis Quality of Life Index.	1 year

Collaborators and Investigators

• Sponsor: Region Östergötland
• Investigators: Principal Investigator: Emanuela Micu, MD PhD, Region Östergötland

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2020
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: August 29, 2020
• First Submitted That Met QC Criteria: September 4, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: DLQI; microwave; hyperhidrosis; hyperhidrosis disease severity scale (HDSS); Hospital Anxiety and Depression Scale (HADS); HYPERHIDROSIS QUALITY OF LIFE INDEX (HidroQoL)
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis
• Other Study ID Numbers: FORSS-932159

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes