UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041685
Receipt number 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 2023/11/29 10:04:55

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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 Risa
Middle name
Last name Fukuda

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 or person

Institute

National Center for Child health and Development

Institute

Department

Personal name



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

No longer 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

2023 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

2023 Year 11 Month 29 Day



Link to view the page

Value
https://center6.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