NCT07434076

Brief Summary

This study is a cross-sectional, observational investigation designed to develop and validate a noninvasive ocular imaging-based predictive model for major inflammatory skin diseases, including psoriasis, atopic dermatitis, and urticaria. Grounded in Traditional Chinese Medicine (TCM) ocular diagnostic theory and integrated with advanced computer vision techniques, the study aims to establish objective, quantifiable biomarkers derived from scleral and bulbar conjunctival images. Approximately 950 participants (patients with psoriasis, atopic dermatitis, urticaria, and healthy controls) will be recruited from a tertiary academic hospital. Standardized high-resolution ocular images will be collected alongside comprehensive clinical, demographic, and comorbidity data. Disease severity will be assessed using validated clinical scoring systems (e.g., PASI, EASI, UAS7, DLQI). Image analysis will combine traditional radiomics feature extraction with deep learning architectures, including a Vision State-Space (VMamba) module for global-local feature representation and a Multi-Gate Mixture-of-Experts (MMoE) framework for multi-task learning. The model is designed to simultaneously perform disease classification and predict comorbidity risks (such as metabolic syndrome, hepatic insulin resistance, and recurrence risk). Primary outcomes include characterization of ocular feature patterns associated with inflammatory skin diseases. Secondary outcomes include correlations between ocular image-derived features and clinical severity indices. Model performance will be evaluated using ROC curves, AUC, calibration analysis, and decision curve analysis. This study aims to provide an objective, digitalized, and clinically applicable ocular biomarker framework to support early diagnosis, risk stratification, and comorbidity screening in inflammatory skin diseases.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
950

participants targeted

Target at P75+ for all trials

Timeline
25mo left

Started Mar 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Mar 2026May 2028

First Submitted

Initial submission to the registry

February 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

March 5, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2028

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

February 19, 2026

Last Update Submit

February 19, 2026

Conditions

PsoriasisAtopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • A TCM ocular diagnostic feature spectrum

    A TCM ocular diagnostic feature spectrum: overall prevalence and pattern combinations of ocular features in the psoriasis group. Incidence rates of characteristic ocular change

    2026.03.05-2028.03.05

Secondary Outcomes (1)

  • Correlations (Spearman's rho) between ocular feature scores and clinical severity scales

    2026.03.05-2028.03.05

Study Arms (4)

Psoriasis subjects

Other: Questionnaire collection

Atopic dermatitis subjects

Other: Questionnaire collection

Urticaria subjects

Other: Questionnaire collection

Healthy controls

Other: Questionnaire collection

Interventions

Questionnaire collectionOTHER

During the study visit investigators will conduct face-to-face interviews and collect the questionnaire data, with confirmation from family members where appropriate.

Atopic dermatitis subjectsHealthy controlsPsoriasis subjectsUrticaria subjects

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

As an exploratory cross-sectional study involving high-dimensional image-omics modeling, we plan to enlarge the sample size. We intend to recruit 200 cases each of psoriasis, atopic dermatitis, and urticaria, and 150 healthy controls. The dataset will be split into training and internal validation sets at an 8:2 ratio. An external independent validation cohort of 200 subjects is planned. The total sample size is therefore approximately 950 participants.

You may qualify if:

  • For patients with inflammatory skin disease:
  • Clinical diagnosis of one of the three target inflammatory skin diseases (psoriasis, atopic dermatitis, or urticaria).
  • Age ≥ 18 and ≤ 65 years, any sex.
  • Understands and signs informed consent.
  • For healthy controls:
  • Do not meet diagnostic criteria for any of the three inflammatory skin diseases above.
  • Age ≥ 18 and ≤ 65 years, any sex.
  • Understands and signs informed consent.

You may not qualify if:

  • For patients with inflammatory skin disease:
  • Exclude any subject meeting any of the following:
  • Refusal to undergo examinations.
  • Presence of acute/active infectious ocular disease (e.g., viral keratoconjunctivitis).
  • Corneal perforation or high-risk perforation where contact procedures cause severe photophobia, eye pain, inability to keep eyes open or fixate.
  • Nystagmus or other conditions that prevent fixation.
  • Pupillary non-dilation (e.g., posterior synechiae) that precludes fundus imaging.
  • Severe eyelid lesions (e.g., marked swelling, ectropion, entropion) that prevent globe exposure.
  • Participation in other clinical trials within the previous 3 months or concurrent participation in other interventional studies.
  • Exclude any subject meeting any of the following:
  • Presence of other skin diseases that could affect study assessments (e.g., atopic dermatitis, urticaria, scabies).
  • Refusal to undergo examinations.
  • Acute/active infectious ocular disease (e.g., viral keratoconjunctivitis).
  • Corneal perforation or high-risk perforation that causes severe photophobia, eye pain, inability to keep eyes open or fixate during contact procedures.
  • Nystagmus or other reasons preventing fixation.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PsoriasisDermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Xin Li, PhD

CONTACT

1366195632613661956326@163.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2026

First Posted

February 25, 2026

Study Start

March 5, 2026

Primary Completion (Estimated)

March 5, 2028

Study Completion (Estimated)

May 25, 2028

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share