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

Sponsor

Merete Haedersdal (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05057117

Collaborator

(none)

Enrollment

Location

Arms

21.1

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 hyperhidrosisA 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 :

Sep 27, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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 Names: 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 Names: miraDry

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 Names:

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 Names:

miraDry

Outcome Measures

Primary Outcome Measures

Subjective change in axillary sweat [Baseline - 6 months]
Unilateral sweat change from baseline to 6 months follow-up assessed by Hyperhidrosis Disease Severity Scale

Secondary Outcome Measures

Objective change in axillary sweat [Baseline - 6 months]
Unilateral sweat change from baseline to 6 months follow-up assessed by gravimetric test
Patient Satisfaction [Baseline - 6 months - 12 months]
Unilateral patient satisfaction 6 and 12 months after treatments assessed on a 3-point Likert Scale (unsatisfied - neutral - satisfied)
Adverse reactions [Baseline - 12 months]
Unilateral evaluation of adverse reactions after treatments

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)