Our objectives in both adult and paediatric psoriasis patients are (I) To validate the Handheld LSCI Device for visualization of vascular changes within psoriatic plaques. (II) Identification of the most active and least active sides of psoriatic…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoints will be:
1. Visualization of vascular involvement as measured by perfusion intensity in
the pathogenesis of psoriasis with the Handheld LSCI Device in both adult and
paediatric psoriasis patients.
2. The detection of *hot-* and *cold spots* within a psoriatic lesion using the
Handheld LSCI Device in both paediatric and adult patients.
3. Identification of vascular involvement in the pre-psoriatic skin and
predicting development and expansion of psoriasis plaques with the Handheld
LSCI Device in both paediatric and adult patients.
Secondary outcome
The secondary study endpoint will be:
1. Comparison of the transcriptome signatures of *hot spots*, *cold spots*,
pre-psoriatic skin and post psoriatic skin as identified with the Handheld LSCI
Device.
Background summary
The process of angiogenesis is a key phenomenon in the development of psoriasis
and is considered to indicate early development of new psoriatic lesions. In
this study we will focus on these (early) detectable changes in the
microcirculation of the psoriatic skin, and more particularly on the predictive
value of these changes on the course of the disease. The non-invasive Handheld
Laser Speckle Contrast Imaging (LSCI) Device, which measures perfusion
intensity, could be used in future as a non-invasive method to predict
treatment outcome, disease development and progression of psoriasis. Our
research could have an impact on clinical (prediction of development of
psoriasis plaques), therapeutic (preventive treatment, new therapeutic targets)
and pathophysiological (psoriasis transcriptome) level.
Study objective
Our objectives in both adult and paediatric psoriasis patients are (I) To
validate the Handheld LSCI Device for visualization of vascular changes within
psoriatic plaques. (II) Identification of the most active and least active
sides of psoriatic lesions as measured by the Handheld LSCI Device. (III) To
test whether the Handheld LSCI Device may reveal the dynamics of the early
changes in microcirculation on the transition from clinically normal skin into
psoriatic lesions. As a secondary objective we will compare the transcriptome
signatures of *hot spots*, *cold spots*, pre-psoriatic skin and post psoriatic
skin in adult patients.
Study design
The study is partly interventional and partly observational using the
non-invasive Handheld LSCI Device to investigate microcirculation changes in
both adult and paediatric psoriasis.
Intervention
Our study will consist of three research cohorts. In cohort 1 (n=8) the natural
course of psoriasis and the development of psoriasis plaques will be observed
by scanning an untreated body area with the Handheld LSCI Device. In patients
in cohort 2 (n=8) the expansion and clearance of psoriasis lesions (induced by
clobetasol ointment), will be observed. Biopsies will be taken from different
perfusion areas within lesions. In adult patients, follow up will take up to 8
weeks. Paediatric patients (n=3) in cohort 3 will be scanned with the Handheld
LSCI Device during 2 regular outpatient clinic visits.
Study burden and risks
There are no immediate benefits for subjects participating in the study, but
this study could unravel new therapeutic targets or strategies. Given the
non-invasive nature of the Handheld LSCI Device we estimate the study risks as
*negligible*. Scanning the skin using the Handheld LSCI Device is painless and
without any discomfort. The punch biopsies for RNA isolation, and
immunohistochemistry are taken according to standard procedure and may be
slightly tender. Scar formation is barely visible.
Rene descartesdreef 1
Nijmegen 6525GL
NL
Rene descartesdreef 1
Nijmegen 6525GL
NL
Listed location countries
Age
Inclusion criteria
Cohort 1 (8 patients):
To enter into this study patients must meet the following criteria:
* * 18 years of age.
* Patients with a diagnosis of unstable plaque psoriasis according to a dermatologist.
* Patients on topical treatment, who are not eligible or willing to receive systemic anti-psoriatic treatment.
* Patients must be willing to discontinue their topical treatment on one body area for a maximum of eight weeks.
* Patients must be willing to give a written informed consent.
* Patients must be able to adhere to the visit schedule.;Cohort 2 (8 patients):
To enter into this study patients must meet the following criteria:
* * 18 years of age.
* Patients with a diagnosis of plaque psoriasis according to a dermatologist.
* Patients who are on topical treatment.
* * two clinically visible plaques with a minimal diameter of three centimetres.
* Patients must be willing to discontinue topical treatment of two plaques for respectively two and a maximum of ten weeks.
* Patients must be able to adhere to the visit schedule.
* If applicable: patients must be willing to switch topical therapy for one psoriasis plaque to clobetasol ointment for a maximum of eight weeks.
* Patients must be willing to undergo six skin biopsies.
* Patients must be willing to give a written informed consent.;Cohort 3 (3 patients):
To enter into this study paediatric patients must meet the following criteria:
* Aged * 6 and < 18 years.
* Patients who are on topical psoriasis treatment or on stable doses of systemic anti-psoriatic treatment.
* Paediatric patients and/or their guardians must be willing to give a written informed consent.
Exclusion criteria
Cohort 1:
* Patients with stable plaque psoriasis according to a dermatologist.
* Patients with a history or signs of other inflammatory skin diseases, for example atopic dermatitis.
* Patients on systemic anti-psoriatic treatment.
* Patients unwilling or unable to give informed consent.;Cohort 2:
Patients will be excluded from this study when any of the following criteria listed below are met:
* Patients with a history or signs of other inflammatory skin diseases, for example atopic dermatitis.
* Patients on systemic anti-psoriatic treatment.
* Patients with a known Koebner phenomenon.
* Patients unwilling or unable to give informed consent.;Cohort 3:
* aged <6 or *18 years of age.
* Patients with a history or signs of other inflammatory skin diseases, for example atopic dermatitis.
* Patients using varying doses of systemic anti-psoriatic treatment (like methotrexate or biologics). Doses have to be stable for at least three months.
* Patients in which the dose of systemic treatment is likely to change over the next three months.
* Patients or parents unwilling or unable to give informed consent.
Design
Recruitment
Medical products/devices used
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 | NL69174.091.19 |