Comparison of different Capsaicin doses and their effects on nerve fibres in the ski

• Conditions: Impact of Capsaicin on epidermal nerve fibres; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2012-002406-46-AT
• Lead Sponsor: Medizinische Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-07
• Last Update Posted: 16 October 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

healthy volunteers
18 > age < 80
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 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

anamnestic injury or surgery of the thighs
Nerved damage (Nervus femoralis or lumbal nerval roots 2-4)

lack or different information by testing of sensitivity disturbance, impaired experience of pain and temperature in the area of the fore side of the thighs
prior use of Qutenza or other topical capsaicin preparations in the area of the firesides of the thighs in between 3 months prior to the start of the investigation

known hypersensitivity to capsaicin

known hypersensitivity to local anesthetic ointment Emla- Creme® (Lidocaine, Prilocaine, Macrogolglycerolhydroxystearat, Carbomer)

known hypersensitivity to Ultrasicc® (Petrolatum, Cera Microcristallina, Stearylalkohol, Macrogolstearat 2000, Polyacrylacid, Natriumedetat, Propyl-4-hydroxybenzoat) as carrier substance of the Capsaicin 0,05% Creme

known hypersensitivity to Qutenza cleansing gel (Macrogol 300, Carbomer 1382, Natriumedetat, Butylhydroxyanisol)
known hypersensitivity to paracetamol

unstable hypertension, current cardiovascular event, methaemoglobinaemia, G6PDH-Insufficiency, hepatic insufficiency, use if antiarrhythmics, known alcohol or drug abuse

participation in another trial

Pregnancy or breast feeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Comparison of different Capsaicin doses on the density of epidermal nerve fibres;Secondary Objective: Comparison of different Capsaicin doses on the density of epidermal nerve fibres,<br>impact of gender;Primary end point(s): epidermal nerve fibre density;Timepoint(s) of evaluation of this end point: 0, 30, 45, 60, 90, 120 mins.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable