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Longevity of Microwave Thermolysis and Botulinum Toxin A for Treatment of Axillary Hyperhidrosis | Clinical Trials | Clareo Health

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

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

NCT05057117•Merete Haedersdal

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+9 more criteria

Locations (1)

Department of Dermatology, Bispebjerg Hospital

Copenhagen, Denmark

Key Dates

Start Date

September 27, 2021

Primary Completion Date

October 17, 2022

Completion Date

April 24, 2023

Last Updated

May 26, 2023

Enrollment

ACTUAL participants

Conditions

Hyperhidrosis Primary Focal Axilla

Interventions

Microwave thermolysis

DEVICE

Botulinum toxin A

DRUG

Treatment of Axillary Hyperhidrosis With Long-pulsed Nd:YAG Laser or IPL

NCT04227691

Hyperhidrosis Primary Focal Axilla

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 26, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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