only Healthy subjects
Conditions
Interventions
Group 1: Provocation with cowhage and histamine after 28-day application of a low pH (pH4) cream on one arm of the subject. Determination of itch intensity (visual analogue scale) and skin pH at day 0
Sponsors
Charité Campus Charité Mitte
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult subjects Subjects must be able to communicate with the investigator. They must be able to understand the contents of the study and consent to participate in the study An existing health insurance (so that potential biopsy-related complications can be taken care of)
Exclusion criteria
Exclusion criteria: Current or previous treatment with immunosuppressants (e.g., prednisolone, ciclosporin A, methotrexate, dapsone or others) 4 weeks or 5 half-lives, whichever is longer, before the start of the study. Intake of antihistamines 5 days and leukotriene antagonists 7 days before study Significant disease through which the subject could have a weakened immune system Presence of a skin disease or of chronic pruritus Pregnant or lactating women In the history, a hypersensitivity or allergy to local anesthetics (in subjects where a skin biopsy is taken). Taking blood thinning medications Allergies to local anesthetic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the itch intensity (visual analogue scale) in the skin with reduced pH, normal pH (untreated skin) and increased pH (all on day 28). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of the skin pH on day 28 after daily application of a cream with low or high pH compared to the skin pH before treatment and on untreated skin on day 28. Immunohistological examinations are performed in some subjects (optional biopsy). These studies have no defined endpoints but are purely exploratory. | — |
Countries
Germany
Contacts
Public ContactHesna Gözlükaya
Klinik für Dermatologie und Allergologie Charité - Universitätsmedizin Berlin
Outcome results
None listed