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Patient Satisfaction and Safety of Miradry Treatment for Axillary Hyperhidrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04546438
Recruitment Status : Unknown
Verified October 2020 by Emanuela Micu, Region Östergötland.
Recruitment status was:  Recruiting
First Posted : September 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Emanuela Micu, Region Östergötland

Study Description
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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.


Condition or disease Intervention/treatment Phase
Axillary Hyperhidrosis Device: miraDry® Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient Quality of Life and Safety of Treatment With Microwave Technology for Axillary Hyperhidrosis
Actual Study Start Date : September 4, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2022
Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. The effectiveness of miraDry treatment [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. Frequency of side effects [ Time Frame: 1 year ]
    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.

  2. Dermatology Life Quality Index assessment [ Time Frame: 1 year ]
    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.

  3. Hospital anxiety and depression scale assessment [ Time Frame: 1 year ]
    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.

  4. Hyperhidrosis Quality of Life Index assessment [ Time Frame: 1 year ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04546438


Contacts
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Contact: Emanuela Micu, MD PhD +460709998040 ema.micu@regionostergotland.se

Locations
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Sweden
Vrinnevisjukhuset Recruiting
Norrköping, Sweden, 60379
Contact: Emanuela Micu, MD, PhD    +460709998040    ema.micu@regionostergotland.se   
Sponsors and Collaborators
Region Östergötland
Investigators
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Principal Investigator: Emanuela Micu, MD PhD Region Östergötland
More Information
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Responsible Party: Emanuela Micu, Principal investigator, MD, PhD, Region Östergötland
ClinicalTrials.gov Identifier: NCT04546438    
Other Study ID Numbers: FORSS-932159
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Emanuela Micu, Region Östergötland:
hyperhidrosis
hyperhidrosis disease severity scale (HDSS)
Hospital Anxiety and Depression Scale (HADS)
 DLQI
HYPERHIDROSIS QUALITY OF LIFE INDEX (HidroQoL)
microwave
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases