Validation of the humanized psoriasis model in NIHIII mice with compounds from the clinic

Completed

Conditions: Flaking disease
Psoriasis
10014982

Registration Number: NL-OMON40678

Lead Sponsor: TNO Triskelion

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Adult Psoriasis patients, m/f, with a mild to moderate form of psoriasis vulgaris, i.e. a maximal PASI score of 18 and a minimum BSA of 3%. Patients are allowed to use local corticosteroids or ointments to prevent dry skin (see Appendix 2).

Exclusion Criteria

Psoriasis patients have NOT received light therapy or another form of SYSTEMIC treatment (e.g. treatment with methotrexate, cyclosporin A or anti-TNF). Gender or age of the adult patients are no exclusion criteria (see Appendix 2).

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>After finalization of the validation study, the transplanted biopsies are<br /><br>isolated to study the psoriatic process via histological techniques. The<br /><br>primary read-out is epidermal thickness.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>After finalization of the validation study, the transplanted biopsies are<br /><br>isolated to study the psoriatic process via histological techniques. The<br /><br>secundary read-out is proliferation and differentiation of cells in the skin.<br /><br>Also, serum is collected on day 21, in which e.g. cytokine measurements can be<br /><br>performed to evaluate the systemic immune reaction.<br /><br>Moreover, the activation and differentiation status of immune cells will be<br /><br>determined in the blood of the donors.</p><br>