Longevity of Microwave Thermolysis and Botulinum Toxin A for Treatment of Axillary Hyperhidrosis

Study Overview
=================
Brief 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.

Official Title
-----------------
Longevity of Microwave Thermolysis and Botulinum Toxin A for Treatment of Axillary Hyperhidrosis: a Randomized Intra-individual Trial

Conditions
-----------------
Hyperhidrosis Primary Focal Axilla

Intervention / Treatment
-----------------
* Device: Microwave thermolysis
* Drug: Botulinum toxin A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A single-center, prospective, randomized, intra-individual, clinical trial comparing longterm efficacy of two treatments for axillary hyperhidrosis
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Botulinum toxin A<br>One treatment with standard dosage (50-100 units) of botulinum toxin A in one axilla | Drug: Botulinum toxin A<br>* Baseline treatment with microwave thermolysis in one axilla and botulinum toxin A in the contralateral axilla, as allocated by randomization<br>* Other names: Botox;|
| Active Comparator: Microwave thermolysis<br>One standard treatment (energy level 5) with microwave thermolysis in one axilla | Device: Microwave thermolysis<br>* Baseline treatment with microwave thermolysis in one axilla and botulinum toxin A in the contralateral axilla, as allocated by randomization<br>* Other names: miraDry;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective change in axillary sweat | Unilateral sweat change from baseline to 6 months follow-up assessed by Hyperhidrosis Disease Severity Scale | Baseline - 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective change in axillary sweat | Unilateral sweat change from baseline to 6 months follow-up assessed by gravimetric test | Baseline - 6 months | 
| Patient Satisfaction | Unilateral patient satisfaction 6 and 12 months after treatments assessed on a 3-point Likert Scale (unsatisfied - neutral - satisfied) | Baseline - 6 months - 12 months | 
| Adverse reactions | Unilateral evaluation of adverse reactions after treatments | Baseline - 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Axillary hyperhidrosis, Microwave thermolysis, Botulinum toxin A