L29.8
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with chronic pruritus and matched (age and gender) healthy controls
Exclusion criteria
Exclusion criteria: - maximal pruritus intensity <3 (VAS, 0-10) in the first two minutes after cowhage or histamine application - skin lesions in the testing site (e.g. erosions, infection) - neurological or severe psychiatric comorbidities according to the medical history - skin type = III (Fitzpatrick; Mediterranean and darker skin types are excluded due tot he lack of data in healthy controls) - allergy against the study substances - disease that prevents the participation in the study - use of medication that influences the perception of pruritus up to1 week prior to study start (e.g. antihistamines, pregabaline/gabapentine, opioids) - use of urea, polidocanol, capsaicin, topical steroids, topical keratolytica, exfoliatives, self-tanners, topical or systemic antihistamines, anticonvulsivants, sedatives up to 1 week prior to study start - systemic steroids up to 2 weeks prior to study start - topical or systemic immunmodulators, antidepressants, drugs against migraine up to 1 month prior to study start - non steroidal or other non-opioid pain killers up to 2 days prior to study start - use of cosmetics or skin care products on the study day - pregnant or breastfeeding women Healthy controls: - atopy - pruritus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference of the pruritus inhibition effect (duration and magnitude of pruritus reduction) by noxious heat/cold stimulation between healthy controls and chronic pruritus patients of various origins in different experimental models: A) cowhage (activation of mechano-sensitive C-fibers) B) histamine (activation of mechano-insensitive C-fibers) C) negative control NaCl: study participants receive saline instead of cowhage or histamine | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Correlation between QST parameters and the pruritus inhibitory effect by thermal pain b) Delta of QST parameters before and after stimulation with Bite Away ® c) Correlation between the intraepidermal nerve fiber density and the magnitude of pruritus inhibition by thermal pain d) Correlation between psychological variables (assessed by standardized questionnaires) and the magnitude of pruritus inhibition by thermal pain | — |
Countries
Germany
Contacts
Komeptenzzentrum Chronischer Pruritus (KCP) und Klinik für Hautkrankheiten, Universitätsklinikum Münster