Characterization and extending the use of the humanized mouse model for psoriasis for pre-clinical testing of new drug.Limited screening of compound B for a pharmaceutical company.Therefore, depending on the success rate of transplantation and…
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
Additionally, several markers which are know to be associated with lesional
psoriasis skin wil be evaluated. This allows us to make a better comparison
between the human situation and the processes seen in the model.
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 will
not experience a direct benifit from participation.
Study objective
Characterization and extending the use of the humanized mouse model for
psoriasis for pre-clinical testing of new drug.
Limited screening of compound B for a pharmaceutical company.
Therefore, depending on the success rate of transplantation and injection, some
of the question stated below will be answered in later studies.
Study design
In this experiment we want to:
- study the dynamics of the psoriatic process and the elements which
influence this process: (needing +/- 10patients)
- determine the efficacy of other treatments used in the clinic
(vitamine D analogs, cyclosporine...): +/- 10 patients
- attempt to validate a prophylactic validation with betamethasone:
(needing +/- 6 patients)
- characterization of the processes in normal skin after transplantation
onto mice and determine if imiquimod will induce psoriasis like pathology in
this skin (as has been reported in mice ) : 10 healthy controls
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
NL
Postbus 2215
2301 CE Leiden
NL
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).;Healthy controls: Adults (m/f) who do not have skin condition (as recognized by physisian or dermatologist)
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);Healthy controls: are not to undergo treatment with drugs like prednisolon and cyclosporine.
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 | NL31570.028.10 |