Back to resultsPatient Satisfaction and Safety of Miradry Treatment for Axillary Hyperhidrosis
Primary Purpose
Axillary Hyperhidrosis
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
miraDry®
Sponsored by
About this trial
This is an interventional treatment trial for Axillary Hyperhidrosis focused on measuring hyperhidrosis, hyperhidrosis disease severity scale (HDSS), Hospital Anxiety and Depression Scale (HADS), DLQI, HYPERHIDROSIS QUALITY OF LIFE INDEX (HidroQoL), microwave
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
Sites / Locations
- VrinnevisjukhusetRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MiraDry® treatment
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04546438
Brief Title
Patient Satisfaction and Safety of Miradry Treatment for Axillary Hyperhidrosis
Official Title
Patient Quality of Life and Safety of Treatment With Microwave Technology for Axillary Hyperhidrosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 4, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Östergötland
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axillary Hyperhidrosis
Keywords
hyperhidrosis, hyperhidrosis disease severity scale (HDSS), Hospital Anxiety and Depression Scale (HADS), DLQI, HYPERHIDROSIS QUALITY OF LIFE INDEX (HidroQoL), microwave
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MiraDry® treatment
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
miraDry®
Intervention Description
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).
Primary Outcome Measure Information:
Title
The effectiveness of miraDry treatment
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Frequency of side effects
Description
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.
Time Frame
1 year
Title
Dermatology Life Quality Index assessment
Description
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.
Time Frame
1 year
Title
Hospital anxiety and depression scale assessment
Description
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.
Time Frame
1 year
Title
Hyperhidrosis Quality of Life Index assessment
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emanuela Micu, MD PhD
Phone
+460709998040
Email
ema.micu@regionostergotland.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emanuela Micu, MD PhD
Organizational Affiliation
Region Östergötland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vrinnevisjukhuset
City
Norrköping
ZIP/Postal Code
60379
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emanuela Micu, MD, PhD
Phone
+460709998040
Email
ema.micu@regionostergotland.se
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Patient Satisfaction and Safety of Miradry Treatment for Axillary Hyperhidrosis
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