Essential Axillary Hyperhidrosis Clinical Trial
Official title:
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.
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.
| Status | Terminated |
| Enrollment | 25 |
| Est. completion date | August 2011 |
| Est. primary completion date | August 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | University Hospital Ghent | Ghent |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Ghent | Allergan |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Effectiviness and duration of effect of both treatments | 1 year | No | |
| Secondary | Adverse events of both treatments | 1 year | Yes |