Evaluation of the Clinical Performance of PsorXD-DermDisk

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00040008

Enrollment

155

Registered

2026-04-23

Start date

2026-08-25

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Differential diagnosis Eczema/Psoriasis

Interventions

Group 1: Patients with a suspected diagnosis of psoriasis or eczema are examined using the PsorXD-DermDisk (blinded) in addition to routine diagnostic procedures. The results are compared with the ref

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects must meet all inclusion criteria as listed below - Signed Informed Consent by study participant or legal guardian - Visual sign of eczema or psoriasis on one or several body parts - Consent to study procedure of minimal invasive sampling - Fulfilment of requirements for medical and familiar history as defined by CRF - Willing to undergo a biopsy in unclear diagnostic assessments - Remaining lesion visible when under local/ systemic therapy

Exclusion criteria

Exclusion criteria: No exclusion criteria must be met to be enrolled into the study - Study participant is not willing to undergo sampling study procedure - No remaining lesion visible, making diagnostic assessment and the minimal invasive sampling infeasible - Study participants with lesions that do not show visible signs of eczema or psoriasis

Design outcomes

Primary

Measure	Time frame
WHAT Evaluation of the clinical performance of PsorXD-DermDisk • Diagnostic sensitivity and specificity against the Reference Method • Positive and negative predictive value against the Reference Method • Likelihood ratio against the Reference Method • Expected values in affected populations WHEN Day 30-60 not later than day 90 after establishment of the final true diagnosis (Reference Method) HOW The Reference Method is the final true diagnosis. This diagnosis is established by two dermatologists based on mutual agreement. If consensus cannot be reached, a third dermatologist is consulted, and the majority decision defines the final true diagnosis. The final true diagnosis is established when all additional diagnostics are available	—

Measure

Time frame

WHAT Evaluation of the clinical performance of PsorXD-DermDisk • Diagnostic sensitivity and specificity against the Reference Method • Positive and negative predictive value against the Reference Method • Likelihood ratio against the Reference Method • Expected values in affected populations WHEN Day 30-60 not later than day 90 after establishment of the final true diagnosis (Reference Method) HOW The Reference Method is the final true diagnosis. This diagnosis is established by two dermatologists based on mutual agreement. If consensus cannot be reached, a third dermatologist is consulted, and the majority decision defines the final true diagnosis. The final true diagnosis is established when all additional diagnostics are available

—

Secondary

Measure	Time frame
• Assessment of PsorXD-DermDisk results against each initial dermatological assessment and Comparative Method (majority opinion of 3 dermatologists) • Assessment of PsorXD-DermDisk result against each histopathological assessment and the majority assessment of 3 histopathologists • Assessment of both Reference Method and Comparative Method against each dermatological and histopathological assessment and majority opinion of histopathologists • Assessment of time and costs for diagnosis using PsorXD-DermDisk against the Reference Method procedure as requested by principal dermatologist • Evaluation of the sampling method: Practicality and user-friendliness of the sampling method used.	—

Measure

Time frame

• Assessment of PsorXD-DermDisk results against each initial dermatological assessment and Comparative Method (majority opinion of 3 dermatologists) • Assessment of PsorXD-DermDisk result against each histopathological assessment and the majority assessment of 3 histopathologists • Assessment of both Reference Method and Comparative Method against each dermatological and histopathological assessment and majority opinion of histopathologists • Assessment of time and costs for diagnosis using PsorXD-DermDisk against the Reference Method procedure as requested by principal dermatologist • Evaluation of the sampling method: Practicality and user-friendliness of the sampling method used.

—

Countries

Germany

Contacts

Public ContactFranziska Schauer

Universitätsklinikum Freiburg Klinik für Dermatologie und Venerologie

franziska.schauer@uniklinik-freiburg.de+49 761 27069950

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Sep 19, 2026