In this project we would like to answer the following questions: To what extent are increased micro-vessel density (MVD) and excessive angiogenesis in inflammatory skin diseases observed during different phases of the disease (i.e. acute/…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main goal of this study will be an extensive evaluation of the
microvasculature and angiogenesis in different phases of psoriatic disease and
in uninvolved skin of psoriatic patients. In this manner more knowledge
regarding angiogenesis and its impact on psoriatic lesion development,
maintenance and remission of this inflammatory skin disease is to be expected.
Biopsies will be processed and tissue sections will be analyzed for the
presence of angiogenesis and the extent of the MVD, using immunohistochemistry
(IHC) and immunofluorescence (IF). The tissues will be stained with markers for
Endothelial Cells (ECs) and markers for cell proliferation and inflammation.
The tissues will be visualized using microscopy, photographed and analyzed
using computer software (Image J).
Secondary outcome
Subsequent to this (pilot) study, the relation of angiogenesis in relation to
other key processes in inflammatory skin disease (i.e. recruitment of immune
cells, cytokine levels, pro- and anti-angiogenic factors and epidermal
proliferation) will be analyzed.
Background summary
Currently there is little known of the role of angiogenesis in inflammatory
skin diseases, such as psoriasis; i.e. the factors that trigger or diminish
angiogenesis and the moment in which angiogenesis starts or stops. One of the
earliest events in the development of psoriatic plaques is a vascular network
expansion, which occurs before epidermal changes. Aberrant dilated capillary
loops have frequently been found in normal looking skin of psoriatic patients.
So angiogenesis may not only be a cofactor but also an inducer of psoriatic
development.
More knowledge about the role of angiogenesis in psoriasis could lead to
exciting new explanations for the induction and support of inflammatory
pathologies, such as autoimmune disease and chronic inflammation. In this
project we will focus on the microvasculature and angiogenesis in different
phases of psoriasis and in uninvolved skin of psoriatic patients.
Study objective
In this project we would like to answer the following questions:
To what extent are increased micro-vessel density (MVD) and excessive
angiogenesis in inflammatory skin diseases observed during different phases of
the disease (i.e. acute/ exacerbation phase, chronic phase, remission phase and
uninvolved skin of for example psoriasis patient).
What can be learnt from the diversity in MVD and angiogenesis during different
phases of psoriasis?
Study design
This study is an explorative observational study; starting with a pilot (n=10)
study to evaluate the margin of spreading in (micro-)vasculature in and
within psoriatic lesions. An additional 50 patients will be included in the
study to analyze the dynamics of treatment (i.e. photo therapy, TNF-inhibitors,
dithranol and clobetasol 17-proprionate) on the vasculature.
Study burden and risks
Patients with psoriasis will be screened and asked for informed consent before
participating in the study. Patients entering the study do receive the same
regular patient care and treatment-regimens as patients who do not enter the
study. All patients entering this study will receive extra procedures,
involving physical examinations and punch biopsies. Biopsies will be taken at
different stages of the disease (i.e. acute/exacerbation, chronic, remission
phase) and from symptomless skin adjacent to the lesion(s) and from the distant
uninvolved skin. The punch biopsies will be taken according to standard
procedure and may be slightly sensitive. Scar formation does not occur or is
barely visible; occasionally the appearance of a psoriatic papule (3mm) at the
site of little trauma may occur and can easily be treated with a topical
corticosteroid.
René Descartesdreef 1 René Descartesdreef 1
Nijmegen 6500HB
NL
René Descartesdreef 1 René Descartesdreef 1
Nijmegen 6500HB
NL
Listed location countries
Age
Inclusion criteria
Patients must meet the following criteria:
- Adults older than 18 years of age
- All patients have tot have chronique plaque psoriasis (i.e. psoriasis vulgaris)
- Patients must be willing to give a written informed consent
- Patients must be able to adhere to the visit schedule
- Applicable in fifty patients; The doctor and the patient decided that the best treatment option was photo therapy, clobetasol 17-proprionate, dithranol or anti-TNF treatment;Criteria voor vrijwilligers:
- Adults older than 18 years of age
- Volunteers must be willing to give written informed consent
- Volunteers must be able to adhere to the visit schedule
Exclusion criteria
Patients will be excluded from this study when any of the following criteria listed below are met:
- Children or adolescents younger than 18 years of age
- Patients with relevant co-morbidities
- Patients with another subtype of psoriasis than psoriasis vulgaris
- Patients with a history of signs of other (inflammatory) skin diseases, for example atopic dermatitis
- Patients who use medication with inhibitory effects on angiogenesis (for example Thalidomide (Softanon®), Sunitinib (Sutent®), COX-2 inhibitors as NSAIDs)
- Patients with co-morbidity that positively or negatively affects angiogenesis (such as microangiopathy and/or peripheral vascular disease in diabetics, smokers, etc)
- Use of anti-psoriatic medication before inclusion:
- Topical medication in the last 7 days
- Systemic medication or photo therapy within the last 4 weeks
- Patients with multiple (superficial) wounds and excoriations
- Patients with contra-indications for any kind of psoriatic treatment;Exclusion criteria for Healthy volunteers:
- Children or adolescents younger than 18 years of age
- Volunteers with relevant co-morbidities
- Volunteers with a history or signs of other (inflammatory) skin diseases, for example atopic dermatitis and psoriasis
- Volunteers who use medication with inhibitory effects on angiogenesis (for example Thalidomide (Softanon®), Sunitinib (Sutent®), COX-2 inhibitors as NSAIDs)
- Volunteers with co-morbidity that positively or negatively affects angiogenesis (such as micro-angiopathy and/or peripheral vascular disease in diabetics, smokers, etc)
- Volunteers with multiple (superficial) wounds and excoriations
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 | NL50490.091.14 |