UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045563 |
|---|---|
| Receipt number | R000052015 |
| Scientific Title | Web-survey for Atopic Dermatitis Control Tool (ADCT) and Other AD Assessment Tools in Japan |
| Date of disclosure of the study information | 2021/09/24 |
| Last modified on | 2026/07/07 16:49:41 |
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Basic information
Public title
Web-survey for atopic dermatitis control in Japan
Acronym
Web-survey for atopic dermatitis control in Japan
Scientific Title
Web-survey for Atopic Dermatitis Control Tool (ADCT) and Other AD Assessment Tools in Japan
Scientific Title:Acronym
Web-survey for ADCT in Japan
Region
| Japan |
Condition
Condition
Atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility of Atopic Dermatitis Control Tool (ADCT) in clinical practice based on the correlation between ADCT and existing assessment tools in patients with atopic dermatitis in Japan
Basic objectives2
Others
Basic objectives -Others
Patient-reported outcomes
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation coefficient between the ADCT score and each of the four following scores (DLQI/POEM/Worst Itch-NRS (WI-NRS)/GQ)
Key secondary outcomes
-ADCT scores overall and by demographic characteristics (demographic characteristics: Age, gender, occupation, annual income, household composition, area of residence, and lifestyle)
-Demographic characteristics by dupilumab users and non-users
-Dosing patterns of dupilumab users (how long administered, whether or not they have ever discontinued it, length of temporary discontinuations)
-ADCT and four (DLQI/POEM/WI-NRS/GQ) scores among dupilumab users and non-users
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Submitted their informed consent and agreed to participate in the survey.
-Responded that they have been diagnosed with atopic dermatitis by a doctor in the past.
-Have visited a medical institution in Japan for atopic dermatitis in the past six months.
-Males and females 20 years old or older who live in Japan and understand and can respond to the questionnaire in Japanese
Key exclusion criteria
-Applicable to inappropriate responses
Target sample size
6200
Research contact person
Name of lead principal investigator
| 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 162-0067 JAPAN
TEL
03-6709-9710
tkusaka@ssri.com
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 162-0067 JAPAN
TEL
03-6709-9710
Homepage URL
HOR@ssri.com
Sponsor or person
Institute
Sanofi K.K.
Institute
Department
Personal name
Funding Source
Organization
Sanofi K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Kitamachi Clinic, Toukeikai Medical Corporation
Address
1-1-3 Kichijoji-Kita-machi, Musashino-shi, Tokyo
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
該当なし/not applicable
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 24 | Day |
Related information
URL releasing protocol
n/a
Publication of results
Published
Result
URL related to results and publications
http://dx.doi.org/10.1093/bjd/ljad344
Number of participants that the trial has enrolled
5546
Results
In 5546 Japanese adult patients with atopic dermatitis, Spearman's rank correlation coefficients showed that total ADCT scores had strong correlations with established AD assessment tools e.g., DLQI, POEM and Worst Itch Numerical Rating Scale (WI-NRS). ADCT sub-item scores also had moderate correlations with the other AD assessment tools with the exception of Q4 (sleep) with the GQ. This demonstrates that ADCT scores can effectively characterise multidimensional AD disease burden.
Results date posted
| 2023 | Year | 09 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Mean age +/- standard deviation [SD] 43.4 +/-11.4 years old; 49.5% male. Mean +/- SD ADCT score of 7.0 +/-4.9.
Participant flow
The Consumer panel provided by Rakuten Insight is comprised of individuals who reported having AD between 2019 and 2021. We asked to voluntarily participate in this study setting the inclusion criteria to enroll subjects who had a physician-reported diagnosis of AD and had sought active AD treatment by visiting a medical institution at least once in the past 6 months. Other inclusion criteria included age of 20 years or older, and having health insurance in Japan. No other criteria to exclude any specific population was applied.
Adverse events
not collected
Outcome measures
The survey included six ADCT questions regarding the participants' AD symptoms in the past week. The total scores range from 0 to 24 with scores of 7 or above indicating poor disease control (binary criteria). The survey also collected data regarding the patients' demographic and disease characteristics and assessed 4 other validated PROs: (1) DLQI, (2) POEM, (3) the Worst Itch-Numerical Rating Scale (WI-NRS) in the past week, and (4) GQ, a 5-point scale for the severity of eczema in the past week. The primary objective was to evaluate the correlation between the ADCT and the DLQI, POEM, WI-NRS, and GQ scores.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 08 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 18 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 18 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 29 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Exploratory outcome(s)
> Understand the patient characteristics by dupilumab dosing pattern among dupilumab users:
- demographic characteristics by whether or not they have ever discontinued dupilumab use
- ADCTDLQI, POEM, WI-NRS, and GQ total scores by whether or not they have ever discontinued dupilumab use
> Evaluate the relationship among QOL26 Questions, each QOL score and usage experience of dupilumab.
- Distribution of responses to QOL26 Questions by the ADCT score (7 points or higher, lower than 7 points)
- Correlation coefficient among the ADCT score, four scores (DLQI/POEM/WI-NRS/GQ), and QOL26 Questions
- Correlation coefficient between each of the ADCT questions and QOL26 Questions
- Distribution of responses to QOL26 Questions by dupilumab users (those who have ever used it) and non-users
Management information
Registered date
| 2021 | Year | 09 | Month | 24 | Day |
Last modified on
| 2026 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052015
