UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051591 |
|---|---|
| Receipt number | R000058851 |
| Scientific Title | Study on QOL by severity in patients with atopic dermatitis - Cross-sectional study using claim data and patient questionnaire on health insurer |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2024/02/09 13:10:27 |
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Basic information
Public title
Study on QOL by severity in patients with atopic dermatitis
Acronym
Study on QOL by severity in patients with atopic dermatitis
Scientific Title
Study on QOL by severity in patients with atopic dermatitis
- Cross-sectional study using claim data and patient questionnaire on health insurer
Scientific Title:Acronym
Study on QOL by severity in patients with atopic dermatitis
- Cross-sectional study using claim data and patient questionnaire on health insurer
Region
| Japan |
Condition
Condition
atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between the severity of atopic dermatitis and the patient's QOL.
Basic objectives2
Others
Basic objectives -Others
PRO(Patient Reported Outcome)
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
DLQI
EQ-5D-5L
Key secondary outcomes
Actual treatment situation and treatment adherence status
TOPICOP
WPAI:GH
Sleep disturbances NRS
Habitual scratching behavior
Disease history
CDLQI
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
Insured individuals aged equal to or older than 19 years or their dependents who have the data of questionnaire implemented by DeSC as of October 2022 through the health promotion support app "kencom"
Key exclusion criteria
None
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Miyuki |
| Middle name | |
| Last name | Matsukawa |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs
Zip code
540-0021
Address
3-2-27 Otedori, Chuo-ku, Osaka
TEL
06-6943-7722
Matsukawa.Miyuki@otsuka.jp
Public contact
Name of contact person
| 1st name | Miyuki |
| Middle name | |
| Last name | Matsukawa |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs
Zip code
540-0021
Address
3-2-27 Otedori, Chuo-ku, Osaka
TEL
06-6943-7722
Homepage URL
Matsukawa.Miyuki@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
The research ethics committee of Otsuka Pharmaceutical Co., Ltd.
Address
463-10 Kagasuno,Kawauchi-cho,Tokushima-city,Tokushima
Tel
088-665-2126
Suzuki.Takashi@otsuka.jp
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 | 08 | Month | 01 | 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
1507
Results
This study shows that atopic dermatitis severity impacts the quality of life in both adults and children. Specifically, skin QOL scores, DLQI and CDLQI, are closely linked with severity, suggesting that ongoing treatment for controlling severity improves QOL. No correlation was found between atopic dermatitis severity and TOPICOP score, indicating some patients have anxiety about topical steroids regardless of severity.
Results date posted
| 2024 | Year | 02 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of the 1507 cases in the analysis population, 810 were male and 697 were female, with an age of 46.2, 10.5 years (mean, SD).
Participant flow
Adverse events
Outcome measures
Severity of atopic dermatitis (POEM, pruritic NRS) and quality of life (DLQI, EQ-5D-5L)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To examine the relation between severity of atopic dermatitis and quality of life, sleep, disease on daily life activities, productivity loss, or topical corticosteroids phobia.
Management information
Registered date
| 2023 | Year | 07 | Month | 12 | Day |
Last modified on
| 2024 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058851
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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