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

NCT05057117 | Completed Phase 4 DMC

• 3 other identifiers: MWT-BTXA2021-000877-10H-21013548
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Axillary hyperhidrosis; Microwave thermolysis; Botulinum toxin A

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Objective change in axillary sweat

  Baseline - 6 months

• Patient Satisfaction

  Baseline - 6 months - 12 months

• Adverse reactions

  Baseline - 12 months

Study Arms (2)

Botulinum toxin A

ACTIVE COMPARATOR

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

Drug: Botulinum toxin A

Microwave thermolysis

ACTIVE COMPARATOR

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

Device: Microwave thermolysis

Interventions

Microwave thermolysis DEVICE

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

Also known as: miraDry

Microwave thermolysis

Botulinum toxin A DRUG

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

Also known as: Botox

Botulinum toxin A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects with generalized hyperhidrosis
• Medical condition or medications that may alter perspiration (e.g. metabolic, immunological or infectious diseases, antidepressants, opioids, adrenergic/cholinergic drugs)
• Topical treatments for axillary hyperhidrosis (anti-perspirants are allowed except for visit days)
• 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

Sponsors & Collaborators

• Merete Haedersdal: lead

Study Sites (1)

Department of Dermatology, Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Merete Haedersdal, MD PhD DMSc

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant in Dermatology, Clinical Professor

Model Details: A single-center, prospective, randomized, intra-individual, clinical trial comparing longterm efficacy of two treatments for axillary hyperhidrosis

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 27, 2021
• Study Start: September 27, 2021
• Primary Completion: October 17, 2022
• Study Completion: April 24, 2023
• Last Updated: May 26, 2023

Record last verified: 2023-05

Locations

DK (1)