Axillary HyperhidrosisNCT04546438
Patient Satisfaction and Safety of Miradry Treatment for Axillary Hyperhidrosis
A study testing miraDry® in people with Axillary Hyperhidrosis, run by Region Östergötland at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Axillary Hyperhidrosis
- What is being tested?
- miraDry®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 4 Sep 2020to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- miraDry®
- Keywords
- hyperhidrosis, hyperhidrosis disease severity scale (HDSS), Hospital Anxiety and Depression Scale (HADS), DLQI, HYPERHIDROSIS QUALITY OF LIFE INDEX (HidroQoL), microwave
- Medical subject headings
- Hyperhidrosis, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: miraDry® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start4 Sep 2020
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axillary HyperhidrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Östergötland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emanuela Micu, Region Östergötland
- Investigators
- Emanuela Micu, MD PhD, Principal investigator, Region Östergötland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546438
- Sponsor's protocol ID
- FORSS-932159
- Status last verified
- Dec 2023
- First submitted
- 29 Aug 2020
- Last updated
- 29 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Quality of Life and Safety of Treatment With Microwave Technology for Axillary Hyperhidrosis
- ClinicalTrials.gov ID
- NCT04546438
- Acronym / sponsor ID
- FORSS-932159
- 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 type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Region ÖstergötlandUniversity, hospital or other
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MiraDry® treatment | Experimental | Device: miraDry®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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | MiraDry® treatment |
Primary outcome
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.
4 secondary outcomes
Frequency of side effects
Time frame: 1 year
Dermatology Life Quality Index assessment
Time frame: 1 year
Hospital anxiety and depression scale assessment
Time frame: 1 year
Hyperhidrosis Quality of Life Index assessment
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emanuela Micu, MD PhD principal investigator
Region Östergötland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing miraDry® in people with Axillary Hyperhidrosis, run by Region Östergötland at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effectiveness of miraDry treatment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.