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

Primary Purpose

Hyperhidrosis Primary Focal Axilla

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Microwave thermolysis

Botulinum toxin A

About this trial

This is an interventional treatment trial for Hyperhidrosis Primary Focal Axilla focused on measuring Axillary hyperhidrosis, Microwave thermolysis, Botulinum toxin A

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Department of Dermatology, Bispebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Botulinum toxin A

Microwave thermolysis

Arm Description

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

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

Outcomes

Primary Outcome Measures

Subjective change in axillary sweat

Unilateral sweat change from baseline to 6 months follow-up assessed by Hyperhidrosis Disease Severity Scale

Secondary Outcome Measures

Objective change in axillary sweat

Unilateral sweat change from baseline to 6 months follow-up assessed by gravimetric test

Patient Satisfaction

Unilateral patient satisfaction 6 and 12 months after treatments assessed on a 3-point Likert Scale (unsatisfied - neutral - satisfied)

Adverse reactions

Unilateral evaluation of adverse reactions after treatments

Full Information

NCT ID

NCT05057117

First Posted

September 7, 2021

Last Updated

May 25, 2023

Sponsor

Merete Haedersdal

1. Study Identification

Unique Protocol Identification Number

NCT05057117

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

September 27, 2021 (Actual)

Primary Completion Date

October 17, 2022 (Actual)

Study Completion Date

April 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Merete Haedersdal

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperhidrosis Primary Focal Axilla

Keywords

Axillary hyperhidrosis, Microwave thermolysis, Botulinum toxin A

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Botulinum toxin A

Arm Type

Active Comparator

Arm Description

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

Arm Title

Microwave thermolysis

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Microwave thermolysis

Other Intervention Name(s)

miraDry

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Botulinum toxin A

Other Intervention Name(s)

Botox

Intervention Description

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

Primary Outcome Measure Information:

Title

Subjective change in axillary sweat

Description

Unilateral sweat change from baseline to 6 months follow-up assessed by Hyperhidrosis Disease Severity Scale

Time Frame

Baseline - 6 months

Secondary Outcome Measure Information:

Title

Objective change in axillary sweat

Description

Unilateral sweat change from baseline to 6 months follow-up assessed by gravimetric test

Time Frame

Baseline - 6 months

Title

Patient Satisfaction

Description

Unilateral patient satisfaction 6 and 12 months after treatments assessed on a 3-point Likert Scale (unsatisfied - neutral - satisfied)

Time Frame

Baseline - 6 months - 12 months

Title

Adverse reactions

Description

Unilateral evaluation of adverse reactions after treatments

Time Frame

Baseline - 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Merete Haedersdal, MD PhD DMSc

Organizational Affiliation

Bispebjerg Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Dermatology, Bispebjerg Hospital

City

Copenhagen

ZIP/Postal Code

2400

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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