not applicable In this trial a potential antinociceptive potency af the IMP (Dysport) will be testet i9n a human inflammatory pain model. The present study will only include heathy volunteers.
Conditions
Interventions
Product Name: Dysport
Product Code: 11101-0309-6
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Dysport
CAS Number: 2-00212
Current Sponsor code: 240672
Other descriptive name: BoNT/
Sponsors
Department of Neurology, Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
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 upper legs 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: Any of the following will exclude a subject from the study: · Previously exposed to Botulinum toxin · Regular use of anticholinergic medication especially anhidrotic drugs, aminoglycosid antibiotics, 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: The objectives of the present study are to demonstrate potential antiinflammatory, antihyperalgesic on the peripheral and/or central level effects of Botulinum toxin a (Dyport). ;Secondary Objective: Furthermore, we want to explore a potential mitigation of BoNT/A by UV-B irradiation and /or the ensuing sunburn reaction of the skin.;Primary end point(s): The main outcome variables will be: 1.for peripheral antihyperalgesic effects: heat pain perception threshold (HPPT) 2.for central antihyperalgesic effects: area of secondary hyperalgesia 3.for anti-inflammatory effects: superficial skin blood flow in the sunburn spots, as assessed with laser Doppler interferometry (LDI) 4.for BoNT/A activity after UV-B irradiation and sunburn: area of anhidrosis as assessed with the iondine starch test (Minor Test). | — |
Countries
Austria
Outcome results
None listed