PsoriasisNCT07434076
Cross-Sectional Study for an Ocular Imaging-Based Predictive Model of Inflammatory Skin Diseases Grounded in Traditional Chinese Medicine
An observational study of Psoriasis and Atopic Dermatitis, run by Shanghai Yueyang Integrated Medicine Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis, Atopic Dermatitis
- What is being tested?
- Questionnaire collection
- How many people
- 950 participants
- Where
- No sites listed yet
- Study dates
- 5 Mar 2026to 25 May 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
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
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).
Read more
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.
- Conditions
- Psoriasis, Atopic Dermatitis
- Being tested
- Questionnaire collection
- Medical subject headings
- Psoriasis, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis subjects | Not described Receives: Other: Questionnaire collection | |
| Atopic dermatitis subjects | Not described Receives: Other: Questionnaire collection | |
| Urticaria subjects | Not described Receives: Other: Questionnaire collection | |
| Healthy controls | Not described Receives: Other: Questionnaire collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2026.03.05-2028.03.05
Secondary outcomes (1)
Correlations (Spearman's rho) between ocular feature scores and clinical severity scales
Correlations (Spearman's rho) between ocular feature scores and clinical severity scales: PASI, BSA, DLQI, VAS, EASI, UAS, and UCT
Measured: 2026.03.05-2028.03.05
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start5 Mar 2026 (estimated)
- Primary completion5 Mar 2028 (estimated)
- Study completion25 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 950 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434076
- Sponsor's protocol ID
- 2026-0220
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Sectional Study for an Ocular Imaging-Based Predictive Model of Inflammatory Skin Diseases Grounded in Traditional Chinese Medicine
- ClinicalTrials.gov ID
- NCT07434076
- Acronym / sponsor ID
- 2026-0220
- Conditions
- Psoriasis, Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 950 participants (estimated)
- Lead sponsor
- Shanghai Yueyang Integrated Medicine HospitalUniversity, hospital or other
- Study start
- 5 Mar 2026 (estimated)
- Primary completion
- 5 Mar 2028 (estimated)
- Study completion
- 25 May 2028 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Psoriasis subjects | – | Other: Questionnaire collection |
| Atopic dermatitis subjects | – | Other: Questionnaire collection |
| Urticaria subjects | – | Other: Questionnaire collection |
| Healthy controls | – | Other: Questionnaire collection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
- Do not meet diagnostic criteria for any of the three inflammatory skin diseases above.
- Age ≥ 18 and ≤ 65 years, any sex.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire collectionDuring the study visit investigators will conduct face-to-face interviews and collect the questionnaire data, with confirmation from family members where appropriate. | Other | Atopic dermatitis subjects, Healthy controls, Psoriasis subjects, Urticaria subjects |
Primary outcome
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
1 secondary outcome
Correlations (Spearman's rho) between ocular feature scores and clinical severity scales
Time frame: 2026.03.05-2028.03.05
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis and Atopic Dermatitis, run by Shanghai Yueyang Integrated Medicine Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Li, PhD (13661956326, 13661956326@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A TCM ocular diagnostic feature spectrum (time frame: 2026.03.05-2028.03.05). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026; AzTrials last refreshed its copy on 27 Oct 2026.