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.

June 3, 2015 updated by: University Hospital, Ghent

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Suction curettage
Procedure: Suction curettage
Suction curettage
Active Comparator: 2
Treatment with Botox
Drug: Treatment with Botox
Treatment with Botox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effectiviness and duration of effect of both treatments
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events of both treatments
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

Allergan

Investigators

  • Principal Investigator: Katia Ongenae, MD, PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

April 28, 2008

First Submitted That Met QC Criteria

April 29, 2008

First Posted (Estimate)

April 30, 2008

Study Record Updates

Last Update Posted (Estimate)

June 4, 2015

Last Update Submitted That Met QC Criteria

June 3, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008/219

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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