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

NCT ID: NCT05057117

Last Updated: 2023-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-27
• Study Completion Date: 2023-04-24

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.

Conditions

Hyperhidrosis Primary Focal Axilla

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Botulinum toxin A

One treatment with standard dosage (50-100 units) of botulinum toxin A in one axilla

Group Type: ACTIVE_COMPARATOR

Botulinum toxin A

Intervention Type: DRUG

Baseline treatment with microwave thermolysis in one axilla and botulinum toxin A in the contralateral axilla, as allocated by randomization

Microwave thermolysis

One standard treatment (energy level 5) with microwave thermolysis in one axilla

Group Type: ACTIVE_COMPARATOR

Microwave thermolysis

Intervention Type: DEVICE

Baseline treatment with microwave thermolysis in one axilla and botulinum toxin A in the contralateral axilla, as allocated by randomization

Interventions

Microwave thermolysis

Baseline treatment with microwave thermolysis in one axilla and botulinum toxin A in the contralateral axilla, as allocated by randomization

Intervention Type: DEVICE

Botulinum toxin A

Baseline treatment with microwave thermolysis in one axilla and botulinum toxin A in the contralateral axilla, as allocated by randomization

Intervention Type: DRUG

Other Intervention Names

miraDry; Botox

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merete Haedersdal

OTHER

Sponsor Role: lead

Responsible Party

Merete Haedersdal

Consultant in Dermatology, Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Merete Haedersdal, MD PhD DMSc

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

Department of Dermatology, Bispebjerg Hospital

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

2021-000877-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

H-21013548

Identifier Type: OTHER

Identifier Source: secondary_id

MWT-BTXA

Identifier Type: -

Identifier Source: org_study_id