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

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.

Study Overview

• Status: Completed
• Conditions: Hyperhidrosis Primary Focal Axilla
• Intervention / Treatment: Drug: Botulinum toxin A; Device: Microwave thermolysis

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Department of Dermatology, Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: Merete Haedersdal
• Investigators: Principal Investigator: Merete Haedersdal, MD PhD DMSc, Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Actual): October 17, 2022
• Study Completion (Actual): April 24, 2023

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: September 15, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Botulinum toxin A; Axillary hyperhidrosis; Microwave thermolysis
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: MWT-BTXA; 2021-000877-10 (EudraCT Number); H-21013548 (Other Identifier: The Regional Health Research Ethics Committee)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No