Status:
TERMINATED
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.
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Allergan
Conditions:
Essential Axillary Hyperhidrosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00669474
Start Date
June 1 2009
End Date
August 1 2011
Last Update
June 4 2015
Active Locations (1)
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1
University Hospital Ghent
Ghent, Belgium, 9000