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. - Tabular View

Tracking Information

First Received Date ^ICMJE

April 28, 2008

Last Updated Date

April 23, 2009

Start Date ^ICMJE

June 2009

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00669474 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Essential Axillary Hyperhidrosis

Intervention ^ICMJE

Procedure: Suction curettage
Drug: Treatment with Botox

Study Arms / Comparison Groups

Other: Suction curettage
Active Comparator: Treatment with Botox

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2011

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Contacts ^ICMJE

Contact: Katia Ongenae, MD, PhD		Katia.ongenae@ugent.be
Contact: Tine Strobbe, MD		T.strobbe@ugent.be

Location Countries ^ICMJE

Belgium

Administrative Information

NCT ID ^ICMJE

NCT00669474

Responsible Party

Katia Ongenae, MD, PhD, University Hospital Ghent

Study ID Numbers ^ICMJE

2008/219

Study Sponsor ^ICMJE

University Hospital, Ghent

Collaborators ^ICMJE

Allergan

Investigators ^ICMJE

Principal Investigator:

Katia Ongenae, MD, PhD

University Hospital, Ghent

Information Provided By

University Hospital, Ghent

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP