UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058505 |
|---|---|
| Receipt number | R000066890 |
| Scientific Title | Atopic Dermatitis in Clinical Practice Patient Reported Outcome(PRO)Fact-Finding Study |
| Date of disclosure of the study information | 2025/07/18 |
| Last modified on | 2026/01/27 16:09:16 |
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Basic information
Public title
Atopic Dermatitis in Clinical Practice Patient Reported Outcome(PRO)Fact-Finding Study
Acronym
AD PRO Study
Scientific Title
Atopic Dermatitis in Clinical Practice Patient Reported Outcome(PRO)Fact-Finding Study
Scientific Title:Acronym
AD PRO Study
Region
| Japan |
Condition
Condition
Atopic Dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the actual use of PRO in atopic dermatitis practice
Basic objectives2
Others
Basic objectives -Others
Descriptive research using questionnaires
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Usage of PRO, Demographic characteristics
Key secondary outcomes
Impact of using PRO, Notes on the use of PRO, Elements needed to promote PRO use/information needs
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Physicians who meet all of the following selection criteria will be included in this study
Outpatient services, Treated at least 10 patients with atopic dermatitis in the last month, The individual's consent to participate in the research is obtained
Key exclusion criteria
No exclusion criteria are set
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yasuhito |
| Middle name | |
| Last name | Konishi |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs Department
Zip code
1088242
Address
Shinagawa Grand Central Tower, 2-16-4 Konan, Minato-ku, Tokyo, Japan
TEL
0367171400
Konishi.Yasuhito@otsuka.jp
Public contact
Name of contact person
| 1st name | Yasuhito |
| Middle name | |
| Last name | Konishi |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs Department
Zip code
1088242
Address
Shinagawa Grand Central Tower, 2-16-4 Konan, Minato-ku, Tokyo, Japan
TEL
0367171400
Homepage URL
Konishi.Yasuhito@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
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
Tokeikai Medical Corporation Kitamachi Clinic Ethics Review Committee
Address
1-1-3 Kitamachi, Kichijoji, Musashino-shi, Tokyo, Japan
Tel
0367798166
chi-pr-ec-kitamachi@cmicgroup.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 18 | 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
385
Results
The rate of routine PRO use in daily clinical practice for atopic dermatitis remains low, at approximately 30%, and the challenges associated with its implementation differ according to physicians' experience with PRO usage. While the continuous use of PRO offers clinical benefits such as reduced consultation time and promotion of patient behavioral changes, increased workload for healthcare staff has been identified as a key challenge.
Results date posted
| 2026 | Year | 01 | Month | 27 | Day |
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
Completed
Date of protocol fixation
| 2025 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 09 | Month | 19 | Day |
Other
Other related information
To conduct a questionnaire survey via a web and tabulate demographic characteristics, the actual use of PRO in the treatment of atopic dermatitis, changes obtained and expected with the use of PRO, as well as points to keep in mind when using PRO and elements/information needs for their promotion
Management information
Registered date
| 2025 | Year | 07 | Month | 17 | Day |
Last modified on
| 2026 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066890
