FindTrial
Sign In

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

Epidermal Nerve Fibre Density Reduction as a Function of Application Time of topical high-dose and low-dose Capsaicin - Capsaicin dose and reduction of ENF density

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-002406-46-AT
Enrollment
Unknown
Registered
2012-09-07
Start date
2012-10-09
Completion date
Unknown
Last updated
2012-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impact of Capsaicin on epidermal nerve fibres

Interventions

Trade Name: Qutenza Product Name: Qutenza Product Code: N01BX04 Pharmaceutical Form: Cutaneous patch INN or Proposed INN: Capsaicin CAS Number: 404-86-4 Current Sponsor code: NGX 4010 Other descriptiv

Sponsors

Medizinische Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: healthy volunteers 18 > age =65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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, 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

MeasureTime frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable—

Countries

Austria

Contacts

Public ContactUniversitätsklinik für Anästhesie

Medizinische Universität Wien

joerg.hiesmayr@meduniwien.ac.at00431404004108

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026