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 is not yet open for participant recruitment.

Verified by University Hospital, Ghent, April 2009

First Received: April 28, 2008 Last Updated: April 23, 2009 History of Changes

Sponsor:	University Hospital, Ghent
Collaborator:	Allergan
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00669474

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 IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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:	June 2011
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Suction curettage	Procedure: Suction curettage Suction curettage
2: Active Comparator 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

Contacts

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

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 ( Katia Ongenae, MD, PhD )
Study ID Numbers:	2008/219
Study First Received:	April 28, 2008
Last Updated:	April 23, 2009
ClinicalTrials.gov Identifier:	NCT00669474 History of Changes
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:

Skin Diseases
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents

Sweat Gland Diseases
Hyperhidrosis
Botulinum Toxin Type A
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009