Test efficacy of compound B in humanized mouse model of psoriasis.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Effect on the psoriatic process is tested by histology and immuno-histochemical
techniques in the transplanted biopsies.
Main read-out epidermal thickness.
Secondary outcome
Serum markers in blood of transplanted mice will be studied together with
markers on culture cells from psoriasis patients.
Background summary
Psoriasis is a highly prevalent disease which has great impact on the quality
of life of patients. Current treatments are far
from ideal. The development of new compounds requires validation in a animal
model, however many differences exsist
between the skin of most animals and humans.
The department of biosciences at TNO has acquired expertise in the past year in
transplanting human psoriasis skin on to
a mouse. Thereby, we are able to do pre-clinical testing of compounds for
psoriasis. Non-leasional skin is transplanted
after which injection with stimulated T cells induces the psoriatic process.
Scientific background information can be read in Appendix 3 &1 because this
study involves pre-clinical testing, patients
willnot experience a direct benifit from participation.
Study objective
Test efficacy of compound B in humanized mouse model of psoriasis.
Study design
A pharmaceutical company has asked TNO to test a potential new therapy for
psoriasis in our humanized mouse model of psoriasis.
Besides Animal welfare approval, we also need medical ethical clearance for
obtaining skin and blood from psoriasis patients.
The skin will be transplanted onto mice after which blood cells will be
injected into the graft to synchronize development of psoriasis.
As indicated in the study protocol ( appendix 1), 3 skin punch biopsies will be
obtained from non-lesional skin as well as 4 vials of blood (+/- 10ml each).
Additionally, the efficacy of a known topical treatment (calciprotriol) will be
tested to further test the predictability of this mouse model.
Study burden and risks
TNO has arranged Insurance for the patients and healthy controls participating
in this study. However, medical risks are
very low. A week after
obtaining skin and blood samples, the stitches will be removed at the research
center (PT&R) and a check will take place.
With the consent of the patient, the medical practicioner of each patient will
be notified about the participation.
Postbus 2215
2301 CE Leiden
Nederland
Postbus 2215
2301 CE Leiden
Nederland
Listed location countries
Age
Inclusion criteria
Psoriasis patients: Adults (m/f) with a mild form of psoriasis vulgaris (PASI score of maximal 6). Patients are allowed to use localcorticosteriods or ointments to prevent dry skin (see appendix 2).
Exclusion criteria
Psoriasis patients: These patients have not received light therapy or another form of systemic treatment (methotrexaat, cyclosporin A,anti-TNF treatments). Gender or age of the adults are not a exclusion criteria.(see appendix 2)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL32546.028.10 |