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.
Primary Purpose
Essential Axillary Hyperhidrosis
Status
Terminated
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Suction curettage
Treatment with Botox
Sponsored by
About this trial
This is an interventional treatment trial for Essential Axillary Hyperhidrosis
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
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
1
2
Arm Description
Suction curettage
Treatment with Botox
Outcomes
Primary Outcome Measures
Effectiviness and duration of effect of both treatments
Secondary Outcome Measures
Adverse events of both treatments
Full Information
NCT ID
NCT00669474
First Posted
April 28, 2008
Last Updated
June 3, 2015
Sponsor
University Hospital, Ghent
Collaborators
Allergan
1. Study Identification
Unique Protocol Identification Number
NCT00669474
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Study never started
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Axillary Hyperhidrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Suction curettage
Arm Title
2
Arm Type
Active Comparator
Arm Description
Treatment with Botox
Intervention Type
Procedure
Intervention Name(s)
Suction curettage
Intervention Description
Suction curettage
Intervention Type
Drug
Intervention Name(s)
Treatment with Botox
Intervention Description
Treatment with Botox
Primary Outcome Measure Information:
Title
Effectiviness and duration of effect of both treatments
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Adverse events of both treatments
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katia Ongenae, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Related Info
Learn more about this trial
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.
We'll reach out to this number within 24 hrs