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Derma AI: A NON-INTERVENTIONAL, PROSPECTIVE, MULTICENTER STUDY IN JAPAN FOR DEVELOPMENT AND UTILITY INVESTIGATION OF EDUCATIONAL ARTIFICAL INTELLIGENCE (AI) SOFTWARE TO SUPPORT ASSESSMENT OF ATOPIC DERMATITIS SEVERITY

Derma AI: A NON-INTERVENTIONAL, PROSPECTIVE, MULTICENTER STUDY IN JAPAN FOR DEVELOPMENT AND UTILITY INVESTIGATION OF EDUCATIONAL ARTIFICAL INTELLIGENCE (AI) SOFTWARE TO SUPPORT ASSESSMENT OF ATOPIC DERMATITIS SEVERITY - Derma AI

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000052645
Enrollment
1000
Registered
2023-10-30
Start date
2023-11-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Atopic dermatitis (AD)

Interventions

None listed

Sponsors

Pfizer Japan Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Male or female participants 18 years of age or more at the time of Informed Consent is signed (Screen 1). 2. Patients have been or who are diagnosed with AD by a dermatologist. 3. Patients who gave written informed consent prior to participating in this study.

Exclusion criteria

Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: 1. Patients concomitant with skin diseases which affect the area where AD skin image is photographed. 2. Patients whose symptoms are clearly in remission in the area affected by AD and whose EASI score is clearly zero. 3. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Design outcomes

Primary

MeasureTime frame
Diagnostic accuracy of AI software for signs of severity >=2 according to EASI scores (area under the curve [AUC] of Receiver Operatorating Characteristic [ROC] curve of predictive confidence score, specificity, sensitivity, false positive rate, false negative rate, positive predictive value, and negative predictive value)

Secondary

MeasureTime frame
- Diagnostic accuracy of AI software for signs of severity 3 according to EASI scores (AUC of ROC curve of predictive confidence score, specificity, sensitivity, false positive rate, false negative rate, positive predictive value, and negative predictive value) - Diagnostic accuracy of AI software for signs of severity >=1 according to EASI scores (AUC of ROC curve of predictive confidence score, specificity, sensitivity, false positive rate, false negative rate, positive predictive value, and negative predictive value)

Countries

Japan

Contacts

Public ContactKenichi Yamanaka

Pfizer Japan Inc. Medical Affairs, Inflammatory & Immunology

Kenichi.Yamanaka@pfizer.com03-5309-7000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026