Not yet recruitingNCT07885345MOJMIUpdated Oct 21, 2026

Definition of Novel Optoacoustic Biomarkers of Psoriasis and Psoriatic Arthritis

An interventional study of Raster-Scan Optoacoustic Mesoscopy and Multispectral Optoacoustic Tomography in Psoriasis (PsO) and Psoriasis Arthritis, sponsored by University of Erlangen-Nürnberg Medical School. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by University of Erlangen-Nürnberg Medical School · Not applicable, Interventional, and Basic science

Updated Oct 21, 2026Newly registeredGo to Updates ↓

Phase: Not applicable
Study type: Interventional
Enrollment: 192
Allocation: Non-randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Conditions studied

Psoriasis (PsO)
Psoriasis Arthritis

Browse trials for

Psoriasis 1,928

In context

Psoriasis

1,928 studies on the registry are indexed under Psoriasis; 234 are open to participants now.

This study's planned enrollment of 192 is above the median of 70 across 1,472 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

University of Erlangen-Nürnberg Medical School is the lead sponsor of 275 studies on the registry; 52 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

Study design

Phase: Not applicable
Primary purpose: Basic science
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 192 participants (estimated)

Study arms

Other
Icreased Risk for Psoriasis
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.
Device: Raster-Scan Optoacoustic Mesoscopy · Device: Multispectral Optoacoustic Tomography
Other
Mild to Moderate Psoriasis Without Psoriatic Arthritis
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.
Device: Raster-Scan Optoacoustic Mesoscopy · Device: Multispectral Optoacoustic Tomography · Procedure: Skin Biopsy and Skin Sample Collection
Other
Severe Psoriasis Without Psoriatic Arthritis
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.
Device: Raster-Scan Optoacoustic Mesoscopy · Device: Multispectral Optoacoustic Tomography · Procedure: Skin Biopsy and Skin Sample Collection
Other
Mild to Moderate Psoriatic Arthritis
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.
Device: Raster-Scan Optoacoustic Mesoscopy · Device: Multispectral Optoacoustic Tomography · Procedure: Skin Biopsy and Skin Sample Collection
Other
Severe Psoriatic Arthritis
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.
Device: Raster-Scan Optoacoustic Mesoscopy · Device: Multispectral Optoacoustic Tomography · Procedure: Skin Biopsy and Skin Sample Collection
Other
Healthy Control Group
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.
Device: Raster-Scan Optoacoustic Mesoscopy

Interventions

DeviceRaster-Scan Optoacoustic Mesoscopy
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.
DeviceMultispectral Optoacoustic Tomography
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.
ProcedureSkin Biopsy and Skin Sample Collection
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.

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Day 1)

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

1 registry update since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.

Of 118 non-industry interventional studies with no phase under Psoriasis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's planned 14 months is below that.

Counting every sponsor, half of 136 studies reached it within 18 months; a quarter within 8 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 30, 2026
First posted: Oct 21, 2026
StartEst.: Oct 7, 2026
Primary completionEst.: Dec 31, 2027
CompletionEst.: Dec 31, 2027
Last update: Oct 21, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

Registered

First appeared on the registry. No changes since

Oct 21, 2026

Show all 1 update

Oct 21, 2026
First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07885345
Lead sponsor: University of Erlangen-Nürnberg Medical School
Collaborators: Hebrew University of Jerusalem
Responsible party: Angelos Karlas (PD Dr. Dr., Principal Investigator, Department of Vascular Surgery, University of Erlangen-Nürnberg Medical School) — Principal investigator
First posted: Oct 21, 2026
Start date: Oct 7, 2026 (estimated)
Primary completion: Dec 31, 2027 (estimated)
Completion: Dec 31, 2027 (estimated)
Last update: Oct 21, 2026

Study contacts

Angelos Karlas, PD Dr. Dr.

Contact

angelos.karlas@uk-erlangen.de

+49-913185-42647

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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