L29
Conditions
Interventions
Group 1: Visit 1: Treatment with Pruritherm at 49.0°C compared to 42.0°C (histamine)
Group 2: Visit 2: Treatment with Pruritherm at 49.0°C compared to 42.0°C (cowhage)
Group 3: Visit 3: Treatment with
Sponsors
mibeTec GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Healthy volunteers (male or female) aged 18 years or older 2. Subjects understand the nature of the procedure and are providing written informed consent prior to any clinical trial procedure 3. Subjects have had no course of medication, whether prescribed or overthe- counter, in the four weeks before the first clinical trial application and no individual doses in the final two weeks other than vitamins and mineral supplements or, for females, oral contraceptives. 4. Subjects are able (in the investigators opinion) and willing to comply with all clinical trial requirements.
Exclusion criteria
Exclusion criteria: 1. Known active neurological disorders associated with sensory loss, pain, allodynia or hyperalgesia, or known mental disorders 2. Disorders associated with chronic pain 3. Any chronic skin disorders associated with chronic itch in the subject 4. Any chronic inflammatory skin disorders, reportedly associated with chronic itch (e.g. psoriasis) 5. Any acute skin disorders associated with current itch 6. Any condition associated with current pain 7. Any chronic or acute skin disorders associated with lesions on forearms including open wounds or injured skin (e.g. scratch lesions), scalded or burned skin (including sunburn), tumors and malignant changes of the skin 8. Small fibre neuropathy 9. Active implants (e.g. cardiac pacemakers) 10. Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the clinical trial, or may influence the result of the clinical trial, or the participant’s ability to participate in the clinical trial 11. Subjects unable to understand the advantages and disadvantages of the clinical trial 12. Subjects who have been committed to an institution by virtue of an order issued either by the courts or by an authority 13. Current or previous (within 30 days of enrollment) treatment with an investigational medicinal product (IMP), or participation and/or under follow-up in another clinical trial 14. Known abuse of alcohol, drugs, or medicinal products 15. Employees of the sponsor, or employees or relatives of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For both established pruritus models itch sensation is assessed for 20 minutes after heat application measured on a visual analogue scale (VAS) (0 – 100 mm). The primary efficacy endpoint is defined as the itch sensation over time during the observation period measured as the area under the curve (AUC in mm*min). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Blood flow analysis for a comparison of hemodynamics in the affected skin area. Blood flow images using the laser speckle contrast technique with a full-field laser perfusion imager (FLPI) will be taken 2 – 3 minutes after skin provocation but before heat application and 15 – 16 minutes after heat application. The following parameter will be assessed: - Mean blood perfusion in a pre-defined area (region of interest), referred to as relative flux - Volume of wheals induced by SPT with histamine (histamine model only) 20 minutes after skin provocation, i.e. 16 minutes after heat application. - Tolerability of the heat application with the investigational medical device, as reported by the subjects via 5-point verbal rating scale (VRS). | — |
Countries
Germany
Contacts
Public ContactMarcus Maurer
Klinik für Dermatologie, Venerologie und Allergologie; Comprehensive Allergy Center Charité
Outcome results
None listed