Handheld Laser Speckle Contrast Imaging Device for optical microcirculatory perfusion imaging: Clinical, therapeutic and pathophysiological implications for adult- and paediatric psoriasis.
- Conditions
- Psoriasis10014982
- Registration Number
- NL-OMON48499
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 19
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study endpoints will be:<br /><br>1. Visualization of vascular involvement as measured by perfusion intensity in<br /><br>the pathogenesis of psoriasis with the Handheld LSCI Device in both adult and<br /><br>paediatric psoriasis patients.<br /><br>2. The detection of *hot-* and *cold spots* within a psoriatic lesion using the<br /><br>Handheld LSCI Device in both paediatric and adult patients.<br /><br>3. Identification of vascular involvement in the pre-psoriatic skin and<br /><br>predicting development and expansion of psoriasis plaques with the Handheld<br /><br>LSCI Device in both paediatric and adult patients. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary study endpoint will be:<br /><br>1. Comparison of the transcriptome signatures of *hot spots*, *cold spots*,<br /><br>pre-psoriatic skin and post psoriatic skin as identified with the Handheld LSCI<br /><br>Device. </p><br>