Is topical application of compound Z effective in reducing the development of psoriasis, induced in this humanized mouse model?
ID
Source
Brief title
Condition
- Autoimmune disorders
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Efficacy of the therapy is tested by histology and immuno-histochemical
techniques in the transplanted biopsies.
Secondary outcome
Furthermore, the presence of compound Z will be evaluated in the skin after
treatment.
Background summary
Title: Efficacy of topical application of compound Z in a humanized mouse model
of psoriasis.
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. Because this study
involves pre-clinical testing, patients will not experience a direct benifit
from participation.
Study objective
Is topical application of compound Z effective in reducing the development of
psoriasis, induced in this humanized mouse model?
Study design
A pharmceutical company has requested us to investigate a potential new therapy
for psoriasis in our humanized mouse model. Besides animal welfare approval
this study also requires approval of the medical ethics committee, as human
skin biopsies are used. As indicated in the study protocol, 3 biopsies (of 6 mm
in diameter) will be obtained from each patient together with 4 vials of 10cc
of blood (appendix 1)
Biopsies of 22 of the 26 patients will be used to study the new therapy for the
company ( as mentioned in the study protocol). The biopsies from the remaining
4 patients will be used to study the effectiveness of another, beside
betamethasone, known therapy, in this case topical application of vitamin D3.
Herewith, it is our aim to further validate the model.
Study burden and risks
TNO has arranged Insurance for the patients 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
Adults (m/f) with a mild form of psoriasis vulgaris (PASI score of maximal 6). Patients are allowed to use local corticosteriods or ointments to prevent dry skin (see appendix 2).
Exclusion criteria
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 | NL30767.028.09 |