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Handheld Laser Speckle Contrast Imaging Device for optical microcirculatory perfusion imaging: Clinical, therapeutic and pathophysiological implications for adult- and paediatric psoriasis.

Handheld Laser Speckle Contrast Imaging Device for optical microcirculatory perfusion imaging: Clinical, therapeutic and pathophysiological implications for adult- and paediatric psoriasis. - Handheld Laser Speckle Contrast Imaging in psoriasis.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48499
Enrollment
19
Registered
2019-04-23
Start date
2019-10-21
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Interventions

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

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)