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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.

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ClinicalTrials.gov Identifier: NCT00669474
Recruitment Status : Terminated (Study never started)
First Posted : April 30, 2008
Last Update Posted : June 4, 2015
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
University Hospital, Ghent

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.


Condition or disease Intervention/treatment Phase
Essential Axillary Hyperhidrosis Procedure: Suction curettage Drug: Treatment with Botox Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : June 2009
Primary Completion Date : August 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox
U.S. FDA Resources

Arm Intervention/treatment
1
Suction curettage
Procedure: Suction curettage
Suction curettage
Active Comparator: 2
Treatment with Botox
Drug: Treatment with Botox
Treatment with Botox



Primary Outcome Measures :
  1. Effectiviness and duration of effect of both treatments [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Adverse events of both treatments [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00669474


Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Allergan
Investigators
Principal Investigator: Katia Ongenae, MD, PhD University Hospital, Ghent

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00669474     History of Changes
Other Study ID Numbers: 2008/219
First Posted: April 30, 2008    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Hyperhidrosis
Sweat Gland Diseases
Skin Diseases
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents