Longevity of Microwave Thermolysis and Botulinum Toxin A for Treatment of Axillary Hyperhidrosis (NCT05057117) | Clinical Trial Compass
CompletedPhase 4
Longevity of Microwave Thermolysis and Botulinum Toxin A for Treatment of Axillary Hyperhidrosis
Denmark30 participantsStarted 2021-09-27
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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