UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052781 |
|---|---|
| Receipt number | R000060228 |
| Scientific Title | Survey on Actual Clinical Practice for Infantile Atopic Dermatitis |
| Date of disclosure of the study information | 2023/11/13 |
| Last modified on | 2024/12/09 14:40:27 |
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Basic information
Public title
Survey on Actual Clinical Practice for Infantile Atopic Dermatitis
Acronym
Survey on Actual Clinical Practice for Infantile Atopic Dermatitis
Scientific Title
Survey on Actual Clinical Practice for Infantile Atopic Dermatitis
Scientific Title:Acronym
Survey on Actual Clinical Practice for Infantile Atopic Dermatitis
Region
| Japan |
Condition
Condition
Infantile Atopic Dermatitis
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To grasp the actual clinical practice of infantile atopic dermatitis and the reason leading to the clinical practice among pediatricians at institutions with 19 beds or less
Basic objectives2
Others
Basic objectives -Others
Cross-sectional Study by Questionnaire Survey
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Phase IV
Assessment
Primary outcomes
Grasp of the current situation of diagnosis
Grasp of the current situation of treatment
Physician's recognition
Key secondary outcomes
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 inclusion criteria will be included in this study.
1.Pediatricians working at institutions with 19 beds or less
2.Those who responded that they examined 10 or more infants aged 0 years in the most recent 1 month
3.Those who responded that they examine infantile eczema and/or atopic dermatitis in daily clinical practice
4.Those who agree to participate in the survey
Key exclusion criteria
There are no exclusion criteria.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Kana |
| Middle name | |
| Last name | Okamoto |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs
Zip code
108-8242
Address
Shinagawa Grand Central Tower, 2-16-4 Konan, Minato-ku, Tokyo, Japan
TEL
03-6717-1400
Okamoto.Kana@otsuka.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Kusaka |
Organization
Social Survey Research Information Co., Ltd.
Division name
Healthcare BI & MA Service Division Health Outcomes Research
Zip code
162-0067
Address
NMF Shinjuku EAST Bldg., 10-5 Tomihisacho, Shinjuku-ku, Tokyo, Japan
TEL
03-6709-9710
Homepage URL
HOR@ssri.com
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
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address
1-1-3, Kichijoji-kitamachi, Musashino-shi, Tokyo, Japan
Tel
03-6779-8166
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
| 2023 | Year | 11 | Month | 13 | 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
238
Results
85.7% of surveyed were non-allergy specialists.
44% understood the relationship between infantile eczema and Atopic Dermatitis (AD).
92% agreed on the effectiveness of early AD intervention.
The average and median age for diagnosing AD were 7.4 and 6 months.
16.4% correctly diagnosed AD from case photos; 19.3% chose the right medication.
60.5% felt resistance to diagnosing AD, mainly due to parental shock (59.4%).
Results date posted
| 2024 | Year | 12 | Month | 09 | 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
| 2023 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To grasp the actual clinical practice of infantile atopic dermatitis and the reason leading to the clinical practice among pediatricians at institutions with 19 beds or less
Management information
Registered date
| 2023 | Year | 11 | Month | 13 | Day |
Last modified on
| 2024 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060228
