Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05057117
Other study ID # MWT-BTXA
Secondary ID 2021-000877-10H-
Status Completed
Phase Phase 4
First received
Last updated
Start date September 27, 2021
Est. completion date April 24, 2023

Study information

Verified date May 2023
Source Bispebjerg Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 24, 2023
Est. primary completion date October 17, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Microwave thermolysis
Baseline treatment with microwave thermolysis in one axilla and botulinum toxin A in the contralateral axilla, as allocated by randomization
Drug:
Botulinum toxin A
Baseline treatment with microwave thermolysis in one axilla and botulinum toxin A in the contralateral axilla, as allocated by randomization

Locations

Country Name City State
Denmark Department of Dermatology, Bispebjerg Hospital Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Merete Haedersdal

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Objective change in axillary sweat Unilateral sweat change from baseline to 6 months follow-up assessed by gravimetric test Baseline - 6 months
Secondary 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
Secondary Adverse reactions Unilateral evaluation of adverse reactions after treatments Baseline - 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT05860972 - Evaluation of Safety and Efficacy of Morpheus8 Applicator for the Treatment of Focal Hyperhidrosis of the Axillae Using Radio Frequency N/A
Enrolling by invitation NCT04227691 - Treatment of Axillary Hyperhidrosis With Long-pulsed Nd:YAG Laser or IPL N/A
Completed NCT03760198 - Evaluate the Efficacy and Safety of MEDITOXIN in Treatment of Primary Axillary Hyperhidrosis Phase 3