UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045548 |
|---|---|
| Receipt number | R000051989 |
| Scientific Title | Objective assessment of nocturnal itching utilizing an information and communication technology equipment in children with atopic dermatitis. Fundamental Unveiling of Monitoring technology for Itching in children with atopic dermatitis |
| Date of disclosure of the study information | 2021/09/30 |
| Last modified on | 2023/03/29 09:00:36 |
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Basic information
Public title
Objective assessment of nocturnal itching utilizing an information and communication technology equipment in children with atopic dermatitis. Fundamental Unveiling of Monitoring technology for Itching in children with atopic dermatitis
Acronym
Objective assessment of itching in children with atopic dermatitis utilizing Apple Watch
Scientific Title
Objective assessment of nocturnal itching utilizing an information and communication technology equipment in children with atopic dermatitis. Fundamental Unveiling of Monitoring technology for Itching in children with atopic dermatitis
Scientific Title:Acronym
Objective assessment of itching in children with atopic dermatitis
Region
| Japan |
Condition
Condition
atopic dermatitis
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To obtain quantitative data on nighttime scratching behavior in pediatric patients with atopic dermatitis using an ICT device (Itch Tracker with Apple Watch)
Basic objectives2
Others
Basic objectives -Others
To analyze relationship between data obtained from ICT device and skin rash severity, quality of life, inflammatory markers, and other clinical factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To analyze the relationship between the data measured by Itch Tracker with Apple Watch and the following indicators
1. severity of skin rash (EASI)
2.Patient assessment of severity (POEM)
3.Quality of life (CDLQI)
4.Th2 inflammatory markers (SCCA2, TARC)
5. patient assessment of itch (VAS, NRS, itch diary)
Key secondary outcomes
Changes in treatment and its responsiveness before and after quantitative nighttime curettage behavior
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
| 6 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Children aged 6-15 years who have been diagnosed with atopic dermatitis according to Hanifin & Rajka's criteria and are being treated at our clinic, and who are able to wear the Apple Watch at night.
(2) Children who have given their consent to participate in this study.
Key exclusion criteria
(1) If consent for the research is not obtained
(2) When the principal investigator or sub-investigator judges that participation in this research is not appropriate.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Iwai |
Organization
National Hospital Organization Mie National Hospital
Division name
Department of Allergy
Zip code
5140125
Address
359, Osato Kubota-cho, Tsu City
TEL
059-232-2531
fu_mi_n_1986@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Fumiko |
| Middle name | |
| Last name | Iwai |
Organization
National Hospital Organization Mie National Hospital
Division name
Department of Allergy
Zip code
5140125
Address
359, Osato Kubota-cho, Tsu City
TEL
059-232-2531
Homepage URL
fu_mi_n_1986@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization Mie National Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Mie National Hospital
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
National Hospital Mie Hospital
Address
359, Osato Kubota-cho, Tsu City
Tel
059-232-2531
mieclinicalresearch@gmail.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
国立病院機構三重病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | 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
50
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
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 29 | Day |
Date analysis concluded
| 2023 | Year | 09 | Month | 30 | Day |
Other
Other related information
Scratching behavior of patients with atopic dermatitis captured by ICT equipment will be analyzed for association with subjective evaluation of itching by patients and various biomarkers of atopic dermatitis
Management information
Registered date
| 2021 | Year | 09 | Month | 22 | Day |
Last modified on
| 2023 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051989
