Unicentric Comparing Study of Suction Curettage With Standard BOTOX Injection in the Treatment of Patients With Essential Axillar Hyperhidrosis: Comparing of Efficacy, Duration of Effectiveness, and Adverse Events.

Study Overview
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Brief Summary
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Part 1: patients with essential hyperhidrosis are treated one time with suction curettage in both axillae. Part 2: patients with axillary hyperhidrosis receive one treatment with suction curettage in one axilla, and at the same time one treatment with BOTOX injections in the other axilla.

Official Title
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Unicentric Comparing Study of Suction Curettage With Standard BOTOX Injection in the Treatment of Patients With Essential Axillar Hyperhidrosis: Comparing of Efficacy, Duration of Effectiveness, and Adverse Events.

Conditions
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Essential Axillary Hyperhidrosis

Intervention / Treatment
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* Procedure: Suction curettage
* Drug: Treatment with Botox


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 75 years Persistent bilateral primary axillary hyperhidrosis Hidrosis interferes with daily activities of patient Gravimetrically minimal 50 mg spontaneous sweat production in each axilla, measured during 5 minutes in room temperature in calm condition signed informed consent patient can and shall continue the trial until the end, and will follow the instructions correcly women in reproductive period had a pregnancy test Exclusion Criteria: Medical condition that can be dangerous by treatment with BOTOX, including myastenia gravis, Lambert-Eaton syndrome, ALS, and each other disease that can interfere with the neuromuscular function Secundary hyperhidrosis (for example secundary on hyperthyroid problems, lymfoma, malaria) Known allergy against study medication, his components, local anesthesia or iodium Use of aminoglycosids, curare-like products, or other products which can interfere with the neuromuscular function during the study Use of therapy for hyperhidrosis with Aluminium chlorid during the study Infection or skin disease in the area to treat Participation in an other therapeutic study on the same time Botuline toxine treatment in the last 4 months Women who can or who want to become pregnant Women in reproductive period who don't use the appropriate contraception Patients in a situation of which the researchers decide it can be dangerous, or can interfere with the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Suction curettage | Procedure: Suction curettage<br>* Suction curettage<br>|
| Active Comparator: 2<br>Treatment with Botox | Drug: Treatment with Botox<br>* Treatment with Botox<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiviness and duration of effect of both treatments |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events of both treatments |  | 1 year |