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.

Phase 4

Terminated

• Conditions: Essential Axillary Hyperhidrosis
• Interventions: Drug: Treatment with Botox; Procedure: Suction curettage

• Registration Number: NCT00669474
• Lead Sponsor: University Hospital, Ghent

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

Not available

Study Timeline

• Study First Submitted: 2008-04-28
• Study First Submitted QC: 2008-04-29
• Study First Posted: 2008-04-30
• Study Start: 2009-06
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Treatment with Botox	Treatment with Botox
1	Suction curettage	Suction curettage

Primary Outcome Measures

Name	Time	Method
Effectiviness and duration of effect of both treatments	1 year

Secondary Outcome Measures

Name	Time	Method
Adverse events of both treatments	1 year

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium