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.
Information source: University Hospital, Ghent
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Essential Axillary Hyperhidrosis
Intervention: Suction curettage (Procedure); Treatment with Botox (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: University Hospital, Ghent Official(s) and/or principal investigator(s):
Katia Ongenae, MD, PhD, Principal Investigator, Affiliation: University Hospital, Ghent
Overall contact:
Katia Ongenae, MD, PhD, Email: Katia.ongenae@ugent.be
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.
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Effectiviness and duration of effect of both treatments
Secondary outcome: Adverse events of both treatments
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Katia Ongenae, MD, PhD, Email: Katia.ongenae@ugent.be
University Hospital Ghent, Ghent 9000, Belgium
Additional Information
Starting date: May 2008
Ending date: August 2010
Last updated: April 29, 2008
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