UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052645 |
|---|---|
| Receipt number | R000059989 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2023/10/30 |
| Last modified on | 2023/10/30 07:47:26 |
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Basic information
Public title
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
Acronym
Derma AI
Scientific Title
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
Scientific Title:Acronym
Derma AI
Region
| Japan |
Condition
Condition
Atopic dermatitis (AD)
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop an artificial intelligence (AI) to estimate the severity of clinical features (erythema, papule/edema, abrasions, and lichenification) in skin images of patients with AD and to evaluate its accuracy
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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)
Key secondary outcomes
- 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)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Yamanaka |
Organization
Pfizer Japan Inc.
Division name
Medical Affairs, Inflammatory & Immunology
Zip code
151-8589
Address
3-22-7, Yoyogi, Shibuya-ku, Tokyo, Japan
TEL
03-5309-7000
Kenichi.Yamanaka@pfizer.com
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Yamanaka |
Organization
Pfizer Japan Inc.
Division name
Medical Affairs, Inflammatory & Immunology
Zip code
151-8589
Address
3-22-7, Yoyogi, Shibuya-ku, Tokyo, Japan
TEL
03-5309-7000
Homepage URL
Kenichi.Yamanaka@pfizer.com
Sponsor or person
Institute
Pfizer Japan Inc.
Institute
Department
Personal name
Funding Source
Organization
Pfizer Japan Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takahashi Clinic Ethics Committee
Address
Medicalhat 1F , 5-1-31 ,Kitamachi ,Iwaya, Nada-ku, Kobe City, Hyogo, Japan
Tel
078-882-6432
kishimoto.satoshi@neues.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
B7451108
Org. issuing International ID_1
Pfizer Japan Inc.
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a multicenter, non-interventional, prospective, observational study in patients with AD.
The study is planned to be conducted at about 20 study sites in Japan.
All assessments described in this protocol will be conducted as part of routine clinical practice or standard practice guidelines for the patient population and the specialty of the health care providers in countries where this study will be conducted.
Skin images of the study participants will be captured as a study intervention. Up to four skin images will be collected for each participant.
Management information
Registered date
| 2023 | Year | 10 | Month | 30 | Day |
Last modified on
| 2023 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059989
