Epidermal Nerve Fibre Density Reduction as a Function of Application Time of topical high-dose and low-dose Capsaici
- Conditions
- Healthy volunteers
- Registration Number
- DRKS00004587
- Lead Sponsor
- niversitätsklinik Wien
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 12
healthy male and female volunteers 18 > age < 80
informed consent
dermal and neurological integrity of the foresides of the thighs
female volunteers - not pregnant or breast feeding
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 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® (Capsaicin, silicone-adhesives, Diethylenglycolmonoethylether, Dimeticone, Ethylcellulose) cleansing gel (Macrogol 300, Carbomer 1382, Natriumedetat, Butylhydroxyanisol)
known hypersensitivity to paracetamol
unstable hypertension, current cardiovascular event, methaemoglobinaemia, G6PDH-Insufficiency, hepatic insufficiency, use of antiarrhythmics, known alcohol or drug abuse
participation in another trial
Pregnancy or breast feeding
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of ENF density (determined with histological evaluation of skin biopsies) of skin areas treated with low-dose capsaicin and skin areas treated with high-dose capsaicin in skin biopsies taken one week and five weeks after the exposure, as a function of application time respectively.
- Secondary Outcome Measures
Name Time Method investiagtion of the mentioned results for male and female volunteers (gender aspect)<br>expectation: no gender specific disparity<br><br>investiagtion of the maximum systolic and diastolic blood pressure during capsaicin exposure and comparison to values before starting of the investigation<br><br>expectation: no significant increase in blood pressure during the capsaicin treatment