Definition of Novel Optoacoustic Biomarkers of Psoriasis and Psoriatic Arthritis

NCT07885345 — Not applicable, Not yet recruiting, 192 participants, University of Erlangen-Nürnberg Medical School

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Optoakustische Bildgebung in Psoriasis Und Psoriasis-Arthritis

Registry	NCT07885345, acronym MOJMI
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, basic science
Enrollment	192 (Estimated)
Sponsor	University of Erlangen-Nürnberg Medical School (Other); collaborators: Hebrew University of Jerusalem
Conditions	Psoriasis (PsO), Psoriasis Arthritis
Interventions	Raster-Scan Optoacoustic Mesoscopy, Multispectral Optoacoustic Tomography, Skin Biopsy and Skin Sample Collection (Device, procedure)
Dates	start 2026-10-07 (estimated), primary completion 2027-12-31 (estimated), completion 2027-12-31 (estimated), first posted 2026-10-21, last updated 2026-10-21

-Summary

This study investigates changes in the skin and joints of people with psoriasis (PsO) and psoriatic arthritis (PsA) using two non-invasive imaging methods called raster-scan optoacoustic mesoscopy (RSOM) and multispectral optoacoustic tomography (MSOT).

The study will include 192 adults, including people with PsO, people with PsA, people at increased risk of developing these conditions, and healthy participants. RSOM will be used to examine small blood vessels and other features of the skin, while MSOT will be used to examine joints and tissue characteristics. In selected participants, a small skin sample will also be collected for laboratory analysis.

The researchers will investigate relationships between the imaging findings, clinical characteristics, and laboratory findings from skin samples. Computer-based and artificial intelligence (AI)-supported methods will also be used to explore patterns across these different types of data.

The aim is to improve the understanding of changes associated with PsO and PsA and to identify potential imaging features that could be investigated as biomarkers in future studies. The imaging and AI analyses performed in this study are for research purposes only and will not be used to make clinical diagnoses or treatment decisions.

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+Arms and interventions

Arm	Type	Interventions	Description
Icreased Risk for Psoriasis	Other	Device: Raster-Scan Optoacoustic Mesoscopy; Device: Multispectral Optoacoustic Tomography	Participants without psoriasis or psoriatic arthritis who have predefined risk factors for psoriasis according to the study protocol. Participants undergo RSOM and MSOT imaging and the other protocol-defined study assessments.
Mild to Moderate Psoriasis Without Psoriatic Arthritis	Other	Device: Raster-Scan Optoacoustic Mesoscopy; Device: Multispectral Optoacoustic Tomography; Procedure: Skin Biopsy and Skin Sample Collection	Participants with mild to moderate psoriasis (PASI ≤20) without psoriatic arthritis. Participants undergo RSOM and MSOT imaging and the other protocol-defined study assessments. A skin biopsy may be obtained from a characteristic skin lesion for histological and immunohistochemical analysis.
Severe Psoriasis Without Psoriatic Arthritis	Other	Device: Raster-Scan Optoacoustic Mesoscopy; Device: Multispectral Optoacoustic Tomography; Procedure: Skin Biopsy and Skin Sample Collection	Participants with severe psoriasis (PASI >20) without psoriatic arthritis. Participants undergo RSOM and MSOT imaging and the other protocol-defined study assessments. A skin biopsy may be obtained from a characteristic skin lesion for histological and immunohistochemical analysis.
Mild to Moderate Psoriatic Arthritis	Other	Device: Raster-Scan Optoacoustic Mesoscopy; Device: Multispectral Optoacoustic Tomography; Procedure: Skin Biopsy and Skin Sample Collection	Participants with severe psoriatic arthritis (DAPSA >28). Participants undergo RSOM and MSOT imaging and the other protocol-defined study assessments. In participants with a cutaneous manifestation, a skin biopsy may be obtained from a characteristic skin lesion for histological and immunohistochemical analysis.
Severe Psoriatic Arthritis	Other	Device: Raster-Scan Optoacoustic Mesoscopy; Device: Multispectral Optoacoustic Tomography; Procedure: Skin Biopsy and Skin Sample Collection	Participants with severe psoriatic arthritis (DAPSA >28). Participants undergo RSOM and MSOT imaging and the other protocol-defined study assessments. In participants with a cutaneous manifestation, a skin biopsy may be obtained from a characteristic skin lesion for histological and immunohistochemical analysis.
Healthy Control Group	Other	Device: Raster-Scan Optoacoustic Mesoscopy	Healthy participants without psoriasis, psoriatic arthritis, or predefined psoriasis risk factors. Participants undergo RSOM and MSOT imaging and the other protocol-defined study assessments. If a participant independently undergoes a planned vascular surgical procedure, a small skin sample may be obtained from the existing surgical incision without an additional skin incision.

Raster-Scan Optoacoustic Mesoscopy (Device): Participants undergo non-invasive raster-scan optoacoustic mesoscopy (RSOM) of predefined skin regions. The RSOM probe is placed on the skin to assess skin morphology and microvascular features. Up to three characteristic skin lesions and corresponding contralateral reference sites may be examined, together with predefined lesion-free skin regions of the extremities. Each individual RSOM measurement lasts approximately 45-90 seconds, with a total RSOM examination time of approximately 20 minutes.
Multispectral Optoacoustic Tomography (Device): Participants undergo non-invasive multispectral optoacoustic tomography (MSOT). Reference measurements are performed over the radial artery, cephalic vein, and a predefined muscle region. MSOT measurements are subsequently performed at the finger and toe joints and bilaterally at the shoulder, elbow, and knee joints. Each joint measurement lasts approximately 10 seconds, with a total MSOT examination time of approximately 20 minutes.
Skin Biopsy and Skin Sample Collection (Procedure): In participants with suitable skin lesions, a study-specific punch skin biopsy of up to 4 mm is obtained from a characteristic skin lesion for histological and immunohistochemical analysis. No study-specific skin biopsy is performed in participants without skin lesions. If such participants independently undergo a planned vascular surgical procedure, a small skin sample may be obtained from the existing surgical incision without an additional skin incision or surgical procedure.

+Outcome measures

Primary outcomes

Association between RSOM parameters and clinical disease severity [Baseline (Day 1)]: Association between quantitative RSOM-derived skin parameters and clinical disease severity. RSOM parameters include microvascular and dermal features.
Association between RSOM parameters and histological features of skin biopsies [Baseline (Day 1)]: Association between quantitative RSOM-derived skin parameters and histological and immunohistochemical features obtained from skin biopsies, including mast cell-related, inflammatory, and angiogenesis-related markers.
Association between MSOT parameters and clinical disease severity [Baseline (Day 1)]: Association between quantitative MSOT-derived parameters and clinical disease severity in participants with psoriasis and psoriatic arthritis. MSOT parameters include oxygenated hemoglobin (HbO2), deoxygenated hemoglobin (Hb), total hemoglobin (THb), lipid, water, and collagen-related signals.
Association between MSOT parameters and histological features of skin biopsies [Baseline (Day 1)]: Association between quantitative MSOT-derived parameters and histological and immunohistochemical features obtained from skin biopsies, including mast cell-related, inflammatory, and angiogenesis-related markers.

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

Inclusion Criteria:

* Age 18 to 65 years.
* Participants must meet the criteria for one of the following study groups:
* Group A: Healthy participants without psoriasis (PsO) but at increased risk for PsO based on family history and/or smoking-related criteria as defined in the study protocol.
* Group B: Participants with mild to moderate PsO (PASI ≤20) without psoriatic arthritis (PsA).
* Group C: Participants with severe PsO (PASI >20) without PsA.
* Group D: Participants with mild to moderate PsA (DAPSA ≤28).
* Group E: Participants with severe PsA (DAPSA >28).
* Group F: Healthy participants without PsO, PsA, or predefined risk for PsO.
* Ability to understand the study information and provide written informed consent.

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Age below 18 years or above 65 years.
* Strongly pigmented skin that may substantially attenuate the RSOM or MSOT signal.
* Documented or suspected photosensitivity, light intolerance, contact dermatitis, or particularly sensitive skin.
* Open or infected wounds at the measurement sites.
* Presence of a cardiac pacemaker, insulin pump, or other implanted electronic device.
* Regular or chronic use of immunomodulatory medications, including glucocorticoids, that may substantially affect inflammation or mast-cell activity, according to the criteria defined in the study protocol.
* Refusal to participate or inability to provide informed consent.