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

• ClinicalTrials.gov Identifier: NCT05057117
• Recruitment Status: Active, not recruiting
• First Posted: September 27, 2021
• Last Update Posted: July 13, 2022
• Sponsor: Merete Haedersdal
• Information provided by (Responsible Party): Merete Haedersdal, Bispebjerg Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hyperhidrosis Primary Focal Axilla	Device: Microwave thermolysis; Drug: Botulinum toxin A	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A single-center, prospective, randomized, intra-individual, clinical trial comparing longterm efficacy of two treatments for axillary hyperhidrosis
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Longevity of Microwave Thermolysis and Botulinum Toxin A for Treatment of Axillary Hyperhidrosis: a Randomized Intra-individual Trial
• Actual Study Start Date: September 27, 2021
• Estimated Primary Completion Date: October 2022
• Estimated Study Completion Date: July 2023

Arms and Interventions

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 Name: 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 Name: miraDry

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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)

Contacts and Locations

Locations

Denmark

Department of Dermatology, Bispebjerg Hospital

Copenhagen, Denmark, 2400

Sponsors and Collaborators

Merete Haedersdal

Investigators

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

More Information

• Responsible Party: Merete Haedersdal, Consultant in Dermatology, Clinical Professor, Bispebjerg Hospital
• ClinicalTrials.gov Identifier: NCT05057117
• Other Study ID Numbers: MWT-BTXA; 2021-000877-10 ( EudraCT Number ); H-21013548 ( Other Identifier: The Regional Health Research Ethics Committee )
• First Posted: September 27, 2021
• Last Update Posted: July 13, 2022
• Last Verified: July 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Merete Haedersdal, Bispebjerg Hospital:

Axillary hyperhidrosis; Microwave thermolysis; Botulinum toxin A

Additional relevant MeSH terms:

Hyperhidrosis; Sweat Gland Diseases; Skin Diseases; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; Acetylcholine Release Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Neuromuscular Agents; Peripheral Nervous System Agents