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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05057117
Recruitment Status : Active, not recruiting
First Posted : September 27, 2021
Last Update Posted : July 13, 2022
Sponsor:
Information provided by (Responsible Party):
Merete Haedersdal, Bispebjerg Hospital

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

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




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



Information from the National Library of Medicine

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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05057117


Locations
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Denmark
Department of Dermatology, Bispebjerg Hospital
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Merete Haedersdal
Investigators
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Principal Investigator: Merete Haedersdal, MD PhD DMSc Bispebjerg Hospital
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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    Key Record Dates
Last Update Posted: July 13, 2022
Last Verified: July 2022

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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:
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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