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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.

This study is not yet open for participant recruitment.
Study NCT00669474.   Last updated on April 29, 2008.   Information provided by University Hospital, Ghent

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Descriptive Information Fields
Brief 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.
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.
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 one axilla, and at the same time one treatment with BOTOX injections in the other axilla.
Detailed Description
Study Phase Phase IV
Study Type † Interventional
Study Design † Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure † Effectiviness and duration of effect of both treatments [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measure † Adverse events of both treatments [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Condition † Essential Axillary Hyperhidrosis
Intervention † Procedure: Suction curettage
Drug: Treatment with Botox
MEDLINE PMIDs
Links Related Info This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status † Not yet recruiting
Enrollment † 25
Start Date † May 2008
Completion Date August 2010
Eligibility Criteria †

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
Gender Both
Ages 18 Years to 75 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Katia Ongenae, MD, PhD         Katia.ongenae@ugent.be    
Contact: Tine Strobbe, MD         T.strobbe@ugent.be    
Location Countries † Belgium
Administrative Information Fields
NCT ID † NCT00669474
Organization ID 2008/219
Secondary IDs ††
Study Sponsor † University Hospital, Ghent
Collaborators †† Allergan
Investigators †
Principal Investigator:     Katia Ongenae, MD, PhD     University Hospital, Ghent    
Information Provided By University Hospital, Ghent
Verification Date April 2008
First Received Date † April 28, 2008
Last Updated Date April 29, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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