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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 has been terminated.
(Study never started)
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00669474
First received: April 28, 2008
Last updated: August 22, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention Phase
Essential Axillary Hyperhidrosis
 Procedure: Suction curettage
Drug: Treatment with Botox
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Botox
U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Effectiviness and duration of effect of both treatments [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events of both treatments [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: June 2009
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Suction curettage
 Procedure: Suction curettage
Suction curettage
Active Comparator: 2
Treatment with Botox
 Drug: Treatment with Botox
Treatment with Botox

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00669474     History of Changes
Other Study ID Numbers: 2008/219
Study First Received: April 28, 2008
Last Updated: August 22, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Hyperhidrosis
Sweat Gland Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 22, 2013