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.

NCT00669474 | Terminated Phase 4

• 1 other identifier: 2008/219
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Axillary Hyperhidrosis

Outcome Measures

Primary Outcomes (1)

• Effectiviness and duration of effect of both treatments

  1 year

Secondary Outcomes (1)

• Adverse events of both treatments

  1 year

Study Arms (2)

1

OTHER

Suction curettage

Procedure: Suction curettage

2

ACTIVE COMPARATOR

Treatment with Botox

Drug: Treatment with Botox

Interventions

Suction curettage PROCEDURE

Suction curettage

1

Treatment with Botox DRUG

Treatment with Botox

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Allergan: collaborator

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

• Related Info

MeSH Terms

Interventions

Vacuum Curettage; Therapeutics; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Dilatation and Curettage; Curettage; Surgical Procedures, Operative; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Katia Ongenae, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2008
• First Posted: April 30, 2008
• Study Start: June 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: June 4, 2015

Record last verified: 2015-06

Locations

BE (1)