Cross-Sectional Study for an Ocular Imaging-Based Predictive Model of Inflammatory Skin Diseases Grounded in Traditional Chinese Medicine

February 19, 2026 updated by: Shanghai Yueyang Integrated Medicine Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
950

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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.

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

  • Healthy control - exclusion criteria

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.

Pupillary non-dilation (e.g., posterior synechiae) that prevents fundus imaging.

Participation in other clinical studies within the previous 3 months or currently participating in other clinical trials.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthy controls
Other: Questionnaire collection
During the study visit investigators will conduct face-to-face interviews and collect the questionnaire data, with confirmation from family members where appropriate.
Psoriasis subjects
Other: Questionnaire collection
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 subjects
Other: Questionnaire collection
During the study visit investigators will conduct face-to-face interviews and collect the questionnaire data, with confirmation from family members where appropriate.
Urticaria subjects
Other: Questionnaire collection
During the study visit investigators will conduct face-to-face interviews and collect the questionnaire data, with confirmation from family members where appropriate.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
A TCM ocular diagnostic feature spectrum
Time Frame: 2026.03.05-2028.03.05

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlations (Spearman's rho) between ocular feature scores and clinical severity scales
Time Frame: 2026.03.05-2028.03.05
Correlations (Spearman's rho) between ocular feature scores and clinical severity scales: PASI, BSA, DLQI, VAS, EASI, UAS, and UCT
2026.03.05-2028.03.05

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Yueyang Integrated Medicine Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 5, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 25, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026-0220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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