Skip to main content
OpenTrials
Completed

NCT Number: NCT05057117

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Dermatology, Bispebjerg Hospital

Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject has provided written informed consent
  • Subject is 18 years of age or older
  • A unilateral HDSS score of 3 or 4 for each axilla
  • 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).
  • 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

  • Subjects with generalized hyperhidrosis
  • Medical condition or medications that may alter perspiration (e.g. metabolic, immunological or infectious diseases, antidepressants, opioids, adrenergic/cholinergic drugs)
  • Daily use of systemic or topical antibiotics and/or steroids in axillae at the time of inclusion
  • Topical treatments for axillary hyperhidrosis (anti-perspirants are allowed except for visit days)
  • Abnormal skin (e.g. rash, infection, dermatitis) in the axilla at the time of inclusion
  • Breast tissue in the axillae
  • Treatment with Isotretinoin within the past 6 months
  • Axillary laser or IPL treatment within the past 6 months
  • Botulinum toxin-injections in the axillae within the past 12 months prior to baseline
  • Known allergies to botulinum toxin, iodine, lidocaine or adrenaline
  • Prior axillary surgery
  • Limited motion in the shoulder joint or neurologic deficit in upper limb
  • History of diseases resulting in muscle weakness (ALS, Lou Gehrig's), dysphagia (Myasthenia Gravis or Lambert Eaton Syndrome) or respiratory compromise
  • Axillary lymph node enlargement or -removal or lymphedema in either upper limb
  • History of hidradenitis suppurativa or history of reoccurring infections/abscesses
  • History of breast cancer
  • Electronic device implant
  • If female; lactating, pregnant or planning on becoming pregnant during the study
  • 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)

Treatment and study plan

Microwave thermolysis

Device

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

Other names: miraDry

Botulinum toxin A

Drug

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

Other names: Botox

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Merete Haedersdal

Other

Registry information

Official study title

Longevity of Microwave Thermolysis and Botulinum Toxin A for Treatment of Axillary Hyperhidrosis: a Randomized Intra-individual Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Sep 27, 2021
Registry last updated
May 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.