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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042086
Receipt No. R000047989
Scientific Title Safety evaluation of children's skin care products for children with dry skin or mild atopic dermatitis
Date of disclosure of the study information 2020/10/26
Last modified on 2021/06/04

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Basic information
Public title Safety evaluation of children's skin care products for children with dry skin or mild atopic dermatitis
Acronym Safety evaluation of children's skin care products
Scientific Title Safety evaluation of children's skin care products for children with dry skin or mild atopic dermatitis
Scientific Title:Acronym Safety evaluation of children's skin care products
Region
Japan

Condition
Condition Dry skin, mild atopic dermatitis
Classification by specialty
Pediatrics Dermatology Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the safety of children's skin care products after 4 weeks of use, for children aged 4 to 10 with dry skin or mild atopic dermatitis.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Presence or absence of adverse events by severity for which a causal relationship to the test cosmetics cannot be denied after use of the test cosmetics
Key secondary outcomes 1) Existence of all adverse events by severity
2) Skin examination findings before, 2 and 4 weeks after the use of the test cosmetic, and at the appearance of a rash
3) Before use of test cosmetics, after 2 weeks and after 4 weeks stratum corneum water content, transepidermal water loss, skin pH
4) Skin components by Raman spectroscopy before, 2 and 4 weeks after use of test cosmetics: Moisture content, natural moisturizing factor, cholesterol, lactic acid, uric acid, ceramide

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Test item:Moisturizing products, Cleaning products.
Dose:Moisturizing products, Twice a day. Cleaning products, Once a day.
Usage:Moisturizing products, Apply in the morning and evening (after bathing) to the entire body, including the face, excluding the head.
Cleaning products,
Use your hands to spread the hidden parts such as the Body and back, neck and crotch, neck and limbs, and the back of ears so that there is no wash residue. Wash your face with foam and rinse with a soft water pressure shower.
Period:4 weeks
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
4 years-old <=
Age-upper limit
11 years-old >
Gender Male and Female
Key inclusion criteria 1)Patients with mild to moderate dryness diagnosed by a dermatologist, or those diagnosed with mild atopic dermatitis (Those who have been diagnosed with atopic dermatitis according to the U.K. Working Party diagnostic criteria and have an EASI score of 7.0 or less.)
2)Patients aged 4 to 10 at the time of obtaining consent
3)Patients who have received sufficient explanation before participating in this test, and who have obtained the free will of the consent of the substitute after obtaining sufficient understanding.
Key exclusion criteria 1)Persons diagnosed with moderate or higher atopic dermatitis
2)Those who may have allergic symptoms due to the tested cosmetic ingredients
3)Those who are Caucasian or Black
4)Those who participate in other clinical trials
5)In addition, if the principal investigator or co-investigators determine that it is inappropriate
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 Natural Science 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 国立研究開発法人 国立成育医療研究センター (東京都)
National Center for Child Health and Development (Tokyo)

Other administrative information
Date of disclosure of the study information
2020 Year 10 Month 26 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 09 Month 15 Day
Date of IRB
2020 Year 10 Month 19 Day
Anticipated trial start date
2020 Year 10 Month 29 Day
Last follow-up date
2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 10 Month 12 Day
Last modified on
2021 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047989

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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