Skin pH and pruritus

Not Applicable

• Conditions: only Healthy subjects

• Registration Number: DRKS00012743
• Lead Sponsor: Charité Campus Charité Mitte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-13
• Study Completion: 2020-03-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 43

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.<br>Immunohistological examinations are performed in some subjects (optional biopsy). These studies have no defined endpoints but are purely exploratory.