plantar hyperhidrosis
Conditions
Interventions
Trade Name: NEUROBLOC 5000 E/ml - Injektionsloesung
Product Name: NEUROBLOC 5000 E/ml - Injektionsloesung
Pharmaceutical Form: Injection
CAS Number: 93384-43-1
Concentration unit: U/ml unit(s)/millili
Sponsors
Medizinische Universität Wien, Univ.Klinik f.Neurologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Men or women, aged between 19 and 75 years • Body mass index between 15th and 85th percentile • Normal findings in the medical history, physical and neurological examination • without dermatological alterations on the abdomen in the area of measurement • no exposure to Botulinum toxin for at least one year Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Previously exposed to Botulinum toxin • Regular use of anticholinergic medication especially anhidrotic drugs, Aminoglycosid antibodies, abuse of alcoholic beverages • Participation in a clinical trial in the 2 weeks preceding the study • Symptoms of a clinically relevant illness in the 4 weeks before the first study day • Acute skin diseases on the relevant areas • Contraindications to botulinum toxin A: pregnancy, breast feeding, known allergy or hypersensitivity, myasthenia gravis or Eaton-Lambert-syndrom, myopathies and myotonias.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We hypothesize to find a magnificent effect for sweat reduction in the feet of the patients after the injection with Botulinum toxin B after 3 weeks. Hence, in this study the following hypothesis will be tested: • Local injection of BoNT type B shows a statistic significant relevant clinical sweat reduction for patients with plantar hyperhidrosis. • BoTN type B treated patients with plantar hyperhidrosis have an increase of their quality of life. ;Secondary Objective: ;Primary end point(s): sweat reduction for patients with plantar hyperhidrosis | — |
Countries
Austria
Outcome results
None listed