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.

• Status: Terminated
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Ghent
• Collaborator: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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