Hyperhidrosis Primary Focal AxillaPhase 4NCT05057117
Longevity of Microwave Thermolysis and Botulinum Toxin A for Treatment of Axillary Hyperhidrosis
A Phase 4 study testing Microwave thermolysis and Botulinum toxin A in people with Hyperhidrosis Primary Focal Axilla, run by Merete Haedersdal at 1 site in Denmark.
Trial summary
This trial aims is to assess and compare treatment effect of microwave thermolysis and botulinum toxin A for axillary hyperhidrosis with focus on longevity. The investigators also aim to assess patient satisfaction and adverse reactions in relation to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperhidrosis Primary Focal Axilla
- What is being tested?
- Microwave thermolysis and Botulinum toxin A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Sep 2021to 24 Apr 2023
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has provided written informed consent
- Subject is 18 years of age or older
- A unilateral HDSS score of 3 or 4 for each axilla
- A gravimetric measurement of at least 50 mg/5 min for women and 100 mg/5 min for men in at least one axilla. The contralateral axilla should not be below 40 mg (women) and 80 mg (men).
- Women of childbearing potential must be confirmed not pregnant by a negative u-HCG prior to study treatment and must use a safe contraceptive method at baseline.
Who cannot join
- Subjects with generalized hyperhidrosis
- Medical condition or medications that may alter perspiration (e.g. metabolic, immunological or infectious diseases, antidepressants, opioids, adrenergic/cholinergic drugs)
- Daily use of systemic or topical antibiotics and/or steroids in axillae at the time of inclusion
- Topical treatments for axillary hyperhidrosis (anti-perspirants are allowed except for visit days)
- Abnormal skin (e.g. rash, infection, dermatitis) in the axilla at the time of inclusion
- Breast tissue in the axillae
Show all 19Show fewer
- Treatment with Isotretinoin within the past 6 months
- Axillary laser or IPL treatment within the past 6 months
- Botulinum toxin-injections in the axillae within the past 12 months prior to baseline
- Known allergies to botulinum toxin, iodine, lidocaine or adrenaline
- Prior axillary surgery
- Limited motion in the shoulder joint or neurologic deficit in upper limb
- History of diseases resulting in muscle weakness (ALS, Lou Gehrig's), dysphagia (Myasthenia Gravis or Lambert Eaton Syndrome) or respiratory compromise
- Axillary lymph node enlargement or -removal or lymphedema in either upper limb
- History of hidradenitis suppurativa or history of reoccurring infections/abscesses
- History of breast cancer
- Electronic device implant
- If female; lactating, pregnant or planning on becoming pregnant during the study
- Non-eligibility at the discretion of the investigator (e.g. non-compliance, unavailability or other reasons the subject is not believed to be able to comply with the clinical trial protocol)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longevity of Microwave Thermolysis and Botulinum Toxin A for Treatment of Axillary Hyperhidrosis: a Randomized Intra-individual Trial
This trial aims is to assess and compare treatment effect of microwave thermolysis and botulinum toxin A for axillary hyperhidrosis with focus on longevity. The investigators also aim to assess patient satisfaction and adverse reactions in relation to treatment.
- Conditions
- Hyperhidrosis Primary Focal Axilla
- Being tested
- Microwave thermolysis, Botulinum toxin A
- Keywords
- Axillary hyperhidrosis, Microwave thermolysis, Botulinum toxin A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave thermolysisDevice
Also called miraDry
Baseline treatment with microwave thermolysis in one axilla and botulinum toxin A in the contralateral axilla, as allocated by randomization
Botulinum toxin ADrug
Also called Botox
Baseline treatment with microwave thermolysis in one axilla and botulinum toxin A in the contralateral axilla, as allocated by randomization
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin A | Active comparator | One treatment with standard dosage (50-100 units) of botulinum toxin A in one axilla Receives: Drug: Botulinum toxin A |
| Microwave thermolysis | Active comparator | One standard treatment (energy level 5) with microwave thermolysis in one axilla Receives: Device: Microwave thermolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective change in axillary sweat
Unilateral sweat change from baseline to 6 months follow-up assessed by Hyperhidrosis Disease Severity Scale
Measured: Baseline - 6 months
Secondary outcomes (3)
Objective change in axillary sweat
Unilateral sweat change from baseline to 6 months follow-up assessed by gravimetric test
Measured: Baseline - 6 months
Patient Satisfaction
Unilateral patient satisfaction 6 and 12 months after treatments assessed on a 3-point Likert Scale (unsatisfied - neutral - satisfied)
Measured: Baseline - 6 months - 12 months
Adverse reactions
Unilateral evaluation of adverse reactions after treatments
Measured: Baseline - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start27 Sep 2021
- Primary completion17 Oct 2022
- Study completion24 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperhidrosis Primary Focal AxillaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-center, prospective, randomized, intra-individual, clinical trial comparing longterm efficacy of two treatments for axillary hyperhidrosis
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merete Haedersdal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Merete Haedersdal, Bispebjerg Hospital
- Investigators
- Merete Haedersdal, MD PhD DMSc, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057117
- Sponsor's protocol ID
- MWT-BTXA
- Other IDs
- 2021-000877-10, H-21013548
- Status last verified
- May 2023
- First submitted
- 7 Sep 2021
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longevity of Microwave Thermolysis and Botulinum Toxin A for Treatment of Axillary Hyperhidrosis: a Randomized Intra-individual Trial
- ClinicalTrials.gov ID
- NCT05057117
- Acronym / sponsor ID
- MWT-BTXA
- Conditions
- Hyperhidrosis Primary Focal Axilla
- Keywords
- Axillary hyperhidrosis, Microwave thermolysis, Botulinum toxin A
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Merete HaedersdalUniversity, hospital or other
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 17 Oct 2022 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 27 Sep 2021 (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.
This trial aims is to assess and compare treatment effect of microwave thermolysis and botulinum toxin A for axillary hyperhidrosis with focus on longevity. The investigators also aim to assess patient satisfaction and adverse reactions in relation to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single-center, prospective, randomized, intra-individual, clinical trial comparing longterm efficacy of two treatments for axillary hyperhidrosis
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin A | Active comparator | Drug: Botulinum toxin AOne treatment with standard dosage (50-100 units) of botulinum toxin A in one axilla |
| Microwave thermolysis | Active comparator | Device: Microwave thermolysisOne standard treatment (energy level 5) with microwave thermolysis in one axilla |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has provided written informed consent
- Subject is 18 years of age or older
- A unilateral HDSS score of 3 or 4 for each axilla
- A gravimetric measurement of at least 50 mg/5 min for women and 100 mg/5 min for men in at least one axilla. The contralateral axilla should not be below 40 mg (women) and 80 mg (men).
- Women of childbearing potential must be confirmed not pregnant by a negative u-HCG prior to study treatment and must use a safe contraceptive method at baseline.
Key exclusion criteria (19 listed)
- Subjects with generalized hyperhidrosis
- Medical condition or medications that may alter perspiration (e.g. metabolic, immunological or infectious diseases, antidepressants, opioids, adrenergic/cholinergic drugs)
- Daily use of systemic or topical antibiotics and/or steroids in axillae at the time of inclusion
- Topical treatments for axillary hyperhidrosis (anti-perspirants are allowed except for visit days)
- Abnormal skin (e.g. rash, infection, dermatitis) in the axilla at the time of inclusion
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 |
|---|---|---|
| Microwave thermolysisAlso: miraDryBaseline treatment with microwave thermolysis in one axilla and botulinum toxin A in the contralateral axilla, as allocated by randomization | Device | Microwave thermolysis |
| Botulinum toxin AAlso: BotoxBaseline treatment with microwave thermolysis in one axilla and botulinum toxin A in the contralateral axilla, as allocated by randomization | Drug | Botulinum toxin A |
Primary outcome
Subjective change in axillary sweat
Time frame: Baseline - 6 months
Unilateral sweat change from baseline to 6 months follow-up assessed by Hyperhidrosis Disease Severity Scale
3 secondary outcomes
Objective change in axillary sweat
Time frame: Baseline - 6 months
Patient Satisfaction
Time frame: Baseline - 6 months - 12 months
Adverse reactions
Time frame: Baseline - 12 months
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 26 May 2023.
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.
Merete Haedersdal, MD PhD DMSc principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Microwave thermolysis and Botulinum toxin A in people with Hyperhidrosis Primary Focal Axilla, run by Merete Haedersdal at 1 site in Denmark.
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 5 inclusion and 19 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 26 May 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Subjective change in axillary sweat (time frame: Baseline - 6 months). 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 26 May 2023.