Collection of skin tissue and blood samples from patients with mild to moderate psoriasis for efficacy testing of a new compound in a humanized mouse model, and validation of the mouse model.
ID
Source
Brief title
Condition
- Other condition
- Epidermal and dermal conditions
Synonym
Health condition
Donatie weefsel voor proefdieronderzoek voor psoriasis (gehumaniseerd muismodel)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Not applicable
Secondary outcome
Not applicable
Background summary
Psoriasis is a highly prevalent disease (2-3% worldwide) with great impact on
the quality of life of patients. Current treatments are suboptimal. The
development of novel therapeutics requires validation in a preclinical animal
model. Since the skin of most laboratory animals differs significantly from
humans, a humanized mouse model for psoriasis can be applied to evaluate the
efficacy of compounds to treat psoriasis vulgaris.
Study objective
Collection of skin tissue and blood samples from patients with mild to moderate
psoriasis for efficacy testing of a new compound in a humanized mouse model,
and validation of the mouse model.
Study design
Single-center study in the Netherlands
Intervention
Collection of 48 mL blood and 5 skin biopsies
Study burden and risks
- Blood samples will be collected via vena-puncture with possible risks of
slight hemorrhages and bruising at the puncture site. Furthermore, the subject
may faint or experience dizziness.
- Skin tissue will be collected via a skin biopsy procedure (under local
anaesthesia) with the possible risks of mild pain, bleeding from the biopsy
site, local reaction to the anesthetic and scar tissue formation. The risks are
considered to be very low.
There is no direct benefit for the subjects participating in the study as the
skin and blood samples will be collected for
further use in animal studies, investigating new treatments for psoriasis
vulgaris.
Utrechtseweg 48
Zeist 3704 HE
NL
Utrechtseweg 48
Zeist 3704 HE
NL
Listed location countries
Age
Inclusion criteria
- Written informed consent obtained
- Suffering of mild to moderate psoriasis vulgaris
- PASI score of 18 or less and minimum body surface area of 3% at visit 1
Exclusion criteria
- Suffering from extensive psoriasis or having had a non-plaque or drug-induced form of psoriasis.
- A recent serious infection or a history of chronic or recurrent infectious disease.
- Undergoing light therapy or any systemic therapy in the last year
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 | NL58662.028.16 |