Psoriasis (PsO)MOJMINCT07885345
Definition of Novel Optoacoustic Biomarkers of Psoriasis and Psoriatic Arthritis
A study testing Raster-Scan Optoacoustic Mesoscopy, Multispectral Optoacoustic Tomography and Skin Biopsy and Skin Sample Collection in people with Psoriasis (PsO) and Psoriasis Arthritis, run by University of Erlangen-Nürnberg Medical School.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis (PsO), Psoriasis Arthritis
- What is being tested?
- Raster-Scan Optoacoustic Mesoscopy, Multispectral Optoacoustic Tomography and Skin Biopsy and Skin Sample Collection
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- 7 Oct 2026to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Optoakustische Bildgebung in Psoriasis Und Psoriasis-Arthritis
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.
Read more
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.
- Conditions
- Psoriasis (PsO), Psoriasis Arthritis
- Being tested
- Raster-Scan Optoacoustic Mesoscopy, Multispectral Optoacoustic Tomography, Skin Biopsy and Skin Sample Collection
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raster-Scan Optoacoustic MesoscopyDevice
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 TomographyDevice
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 CollectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Icreased Risk for Psoriasis | Other | 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. Receives: Device: Raster-Scan Optoacoustic Mesoscopy; Device: Multispectral Optoacoustic Tomography |
| Mild to Moderate Psoriasis Without Psoriatic Arthritis | Other | 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. Receives: Device: Raster-Scan Optoacoustic Mesoscopy; Device: Multispectral Optoacoustic Tomography; Procedure: Skin Biopsy and Skin Sample Collection |
| Severe Psoriasis Without Psoriatic Arthritis | Other | 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. Receives: Device: Raster-Scan Optoacoustic Mesoscopy; Device: Multispectral Optoacoustic Tomography; Procedure: Skin Biopsy and Skin Sample Collection |
| Mild to Moderate Psoriatic Arthritis | Other | 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. Receives: Device: Raster-Scan Optoacoustic Mesoscopy; Device: Multispectral Optoacoustic Tomography; Procedure: Skin Biopsy and Skin Sample Collection |
| Severe Psoriatic Arthritis | Other | 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. Receives: Device: Raster-Scan Optoacoustic Mesoscopy; Device: Multispectral Optoacoustic Tomography; Procedure: Skin Biopsy and Skin Sample Collection |
| Healthy Control Group | Other | 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. Receives: Device: Raster-Scan Optoacoustic Mesoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between RSOM parameters and clinical disease severity
Association between quantitative RSOM-derived skin parameters and clinical disease severity. RSOM parameters include microvascular and dermal features.
Measured: Baseline (Day 1)
Association between RSOM parameters and histological features of skin biopsies
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.
Measured: Baseline (Day 1)
Association between MSOT parameters and clinical disease severity
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.
Measured: Baseline (Day 1)
Association between MSOT parameters and histological features of skin biopsies
Association between quantitative MSOT-derived parameters and histological and immunohistochemical features obtained from skin biopsies, including mast cell-related, inflammatory, and angiogenesis-related markers.
Measured: Baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start7 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis (PsO)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Responsible party
- Principal investigator, Angelos Karlas, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885345
- Sponsor's protocol ID
- 26-158-Bm
- Acronym
- MOJMI
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No