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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000877-10 | EudraCT Number | ||
| H-21013548 | Other Identifier | The Regional Health Research Ethics Committee |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin A | Active Comparator | One treatment with standard dosage (50-100 units) of botulinum toxin A in one axilla |
|
| Microwave thermolysis | Active Comparator | One standard treatment (energy level 5) with microwave thermolysis in one axilla |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microwave thermolysis | Device | Baseline treatment with microwave thermolysis in one axilla and botulinum toxin A in the contralateral axilla, as allocated by randomization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective change in axillary sweat | Unilateral sweat change from baseline to 6 months follow-up assessed by Hyperhidrosis Disease Severity Scale | Baseline - 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective change in axillary sweat | Unilateral sweat change from baseline to 6 months follow-up assessed by gravimetric test | Baseline - 6 months |
| Patient Satisfaction | Unilateral patient satisfaction 6 and 12 months after treatments assessed on a 3-point Likert Scale (unsatisfied - neutral - satisfied) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merete Haedersdal, MD PhD DMSc | Bispebjerg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, Bispebjerg Hospital | Copenhagen | 2400 | Denmark |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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A single-center, prospective, randomized, intra-individual, clinical trial comparing longterm efficacy of two treatments for axillary hyperhidrosis
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| Botulinum toxin A | Drug | Baseline treatment with microwave thermolysis in one axilla and botulinum toxin A in the contralateral axilla, as allocated by randomization |
|
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| Baseline - 6 months - 12 months |
| Adverse reactions | Unilateral evaluation of adverse reactions after treatments | Baseline - 12 months |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |