Hyperhidrosis Primary Focal Axilla
Conditions
Keywords
Axillary hyperhidrosis, Microwave thermolysis, Botulinum toxin A
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.
Interventions
DEVICEMicrowave thermolysis
Baseline treatment with microwave thermolysis in one axilla and botulinum toxin A in the contralateral axilla, as allocated by randomization
DRUGBotulinum toxin A
Baseline treatment with microwave thermolysis in one axilla and botulinum toxin A in the contralateral axilla, as allocated by randomization
Sponsors
Merete Haedersdal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A single-center, prospective, randomized, intra-individual, clinical trial comparing longterm efficacy of two treatments for axillary hyperhidrosis
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject has provided written informed consent 2. Subject is 18 years of age or older 3. A unilateral HDSS score of 3 or 4 for each axilla 4. 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). 5. 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
1. Subjects with generalized hyperhidrosis 2. Medical condition or medications that may alter perspiration (e.g. metabolic, immunological or infectious diseases, antidepressants, opioids, adrenergic/cholinergic drugs) 3. Daily use of systemic or topical antibiotics and/or steroids in axillae at the time of inclusion 4. Topical treatments for axillary hyperhidrosis (anti-perspirants are allowed except for visit days) 5. Abnormal skin (e.g. rash, infection, dermatitis) in the axilla at the time of inclusion 6. Breast tissue in the axillae 7. Treatment with Isotretinoin within the past 6 months 8. Axillary laser or IPL treatment within the past 6 months 9. Botulinum toxin-injections in the axillae within the past 12 months prior to baseline 10. Known allergies to botulinum toxin, iodine, lidocaine or adrenaline 11. Prior axillary surgery 12. Limited motion in the shoulder joint or neurologic deficit in upper limb 13. History of diseases resulting in muscle weakness (ALS, Lou Gehrig's), dysphagia (Myasthenia Gravis or Lambert Eaton Syndrome) or respiratory compromise 14. Axillary lymph node enlargement or -removal or lymphedema in either upper limb 15. History of hidradenitis suppurativa or history of reoccurring infections/abscesses 16. History of breast cancer 17. Electronic device implant 18. If female; lactating, pregnant or planning on becoming pregnant during the study 19. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective change in axillary sweat | Baseline - 6 months | Unilateral sweat change from baseline to 6 months follow-up assessed by Hyperhidrosis Disease Severity Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective change in axillary sweat | Baseline - 6 months | Unilateral sweat change from baseline to 6 months follow-up assessed by gravimetric test |
| Patient Satisfaction | Baseline - 6 months - 12 months | Unilateral patient satisfaction 6 and 12 months after treatments assessed on a 3-point Likert Scale (unsatisfied - neutral - satisfied) |
| Adverse reactions | Baseline - 12 months | Unilateral evaluation of adverse reactions after treatments |
Countries
Denmark
Outcome results
None listed