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

Phase 4

Completed

• Conditions: Hyperhidrosis Primary Focal Axilla
• Interventions: Drug: Botulinum toxin A; Device: Microwave thermolysis

• Registration Number: NCT05057117
• Lead Sponsor: Merete Haedersdal

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-15
• Study Start: 2021-09-27
• Study First Posted: 2021-09-27
• Primary Completion: 2022-10-17
• Study Completion: 2023-04-24
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-25
• Last Update Posted: 2023-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botulinum toxin A	Botulinum toxin A	One treatment with standard dosage (50-100 units) of botulinum toxin A in one axilla
Microwave thermolysis	Microwave thermolysis	One standard treatment (energy level 5) with microwave thermolysis in one axilla

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Dermatology, Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark