volunteer study with healthy volunteers using the intradermal capsaicin injection and UV-B sunburn as models of hyperalgesia
Conditions
Interventions
Trade Name: Neurodol Tissuegel
Product Name: NEURODOL
Product Code: 2189266
Pharmaceutical Form: Medicated plaster
INN or Proposed INN: Lidocain
Pharmaceutical form of the placebo: Medicated plaster
R
Sponsors
Department of Anaesthesia and General Intensive Care Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 20 healthy volunteers (male:female=1:1) will be included in the study. Age 19-40 years, Body mass index 19-29, drug free, pain free. 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) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnancy, any disease, ongoing pain, previous exposure to UV-light (sun exposure)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In this study the follwing hypotheses will be tested: - Topical application of lidocain decreases the mechanical primary hyperalgesia of the skin compared to vehicle - Thermal thresholds will be decreased by lidocain plaster;Secondary Objective: secondary hyperalgesia, intensitiy and area of inflammation;Primary end point(s): mechanical stimulus response after 12 hours of treatment with topical lidocaine plaster in the sunburn area and in the area of capsaicin injection compared to vehicle | — |
Countries
Austria
Outcome results
None listed