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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041685
Receipt No. R000047568
Scientific Title Analysis of characteristic skin composition in children with atopic dermatitis using in vivo confocal Raman spectroscopy
Date of disclosure of the study information 2020/09/08
Last modified on 2020/09/03

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Basic information
Public title Analysis of characteristic skin composition in children with atopic dermatitis
Acronym Analysis of skin composition
Scientific Title Analysis of characteristic skin composition in children with atopic dermatitis using in vivo confocal Raman spectroscopy
Scientific Title:Acronym Analysis of skin composition
Region
Japan

Condition
Condition non-atopic volunteer, atopic dermatitis
Classification by specialty
Dermatology Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate skin composition (amount of water, natural moisturizing factor, cholesterol, ceramide, etc.) in children with atopic dermatitis using in vivo confocal Raman spectroscopy, and to clarify the skin composition related to the skin barrier function
Basic objectives2 Others
Basic objectives -Others Exploratory cross-sectional study
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Skin parameters (amount of water, natural moisturizing factor, cholesterol, ceramide, etc.) assessed by in vivo confocal Raman spectroscopy and skin measuring equipment
Key secondary outcomes 1.Age-stratified analysis of skin parameters(2-5 years old, 6-10 years old)
2. Correlation between skin composition detected by in vivo confocal Raman spectroscopy and skin parameters measured by skin measuring equipment or dermatological findings
3. Filaggrin and filaggrin-degrading enzymes in the stratum corneum

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
2 years-old <=
Age-upper limit
11 years-old >
Gender Male and Female
Key inclusion criteria 1)Children aged 2 to 10 years old at the time of obtaining informed consent
2)
i)Atopic dermatitis patients
a. Mild to moderate atopic dermatitis (EASI: 1.1 to 21.0)
b. Mild to moderate skin dryness and desquamation scores on both left and right inner forearms
ii)non-atopic volunteer
a. No history of atopic dermatitis
Key exclusion criteria 1)Those who have a serious underlying disease requiring hospitalization
2)Those who are deemed unsuitable for inclusion in the study for any other reason by the outpatient doctors
3)
i)Atopic dermatitis patients
a. Those who get systemic therapy for atopic dermatitis (internal steroids or immunosuppressants etc.)
ii)non-atopic volunteer
a. History of allergic disease
b. Those who have dry skin
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kazue
Middle name
Last name Yoshida
Organization National Center for Child health and Development
Division name Division of Dermatology
Zip code 157-8535
Address 2-10-1,Okura,Setagayaku,Tokyo 157-8535
TEL 03-3416-0181
Email skin_research@ncchd.go.jp

Public contact
Name of contact person
1st name Hazuki
Middle name
Last name Yasuda
Organization National Center for Child health and Development
Division name Division of Dermatology
Zip code 157-8535
Address 2-10-1,Okura,Setagayaku,Tokyo 157-8535
TEL 03-3416-0181
Homepage URL
Email skin_research@ncchd.go.jp

Sponsor
Institute National Center for Child health and Development
Institute
Department

Funding Source
Organization Maruho 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 National Center for Child health and Development
Address 2-10-1,Okura,Setagayaku,Tokyo 157-8535
Tel 03-3416-0181
Email rinri@ncchd.go.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
2020 Year 09 Month 08 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
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 Open public recruiting
Date of protocol fixation
2020 Year 07 Month 20 Day
Date of IRB
2020 Year 07 Month 31 Day
Anticipated trial start date
2020 Year 09 Month 03 Day
Last follow-up date
2021 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In addition to the measurement of skin constituents, filaggrin in the stratum corneum and filaggrin-degrading enzyme, survey by questionnaire and photography.

Management information
Registered date
2020 Year 09 Month 04 Day
Last modified on
2020 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047568

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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