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.

Ghent University Hospital (UZ)

Status and phase

Terminated

Phase 4

Conditions

Essential Axillary Hyperhidrosis

Treatments

Procedure: Suction curettage

Drug: Treatment with Botox

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00669474

2008/219

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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