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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028279
Receipt No. R000032372
Scientific Title A follow-up study to evaluate the infant skin condition in summer
Date of disclosure of the study information 2017/08/10
Last modified on 2019/08/02

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Basic information
Public title A follow-up study to evaluate the infant skin condition in summer
Acronym A study to evaluate the infant skin condition
Scientific Title A follow-up study to evaluate the infant skin condition in summer
Scientific Title:Acronym A study to evaluate the infant skin condition
Region
Japan

Condition
Condition Healthy infants
Classification by specialty
Dermatology Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Understandings of skin condition
Basic objectives2 Others
Basic objectives -Others Observational Study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measurement of infant skin condition
Key secondary outcomes

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
12 months-old <=
Age-upper limit
24 months-old >=
Gender Male and Female
Key inclusion criteria Healthy infants
Key exclusion criteria 1. Infant with chronic sickness.
2. Infant with the severe skin symptoms who needs treatment of an atopic dermatitis et al.
3. The infant infected with a disease of infectibility disease.
4. The infant who judged that a test doctor in attendance was unsuitable as a test participant.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuyuki Okuda
Organization Kao Corporation
Division name R&D - Development Research - Sanitary Products Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7432
Email okuda.yasuyuki@kao.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun Kajiwara
Organization Kao Corporation
Division name R&D - Development Research - Sanitary Products Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7379
Homepage URL
Email kajiwara.jun@kao.co.jp

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
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
Address
Tel
Email

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 DRC株式会社(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 10 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
2017 Year 07 Month 10 Day
Date of IRB
2017 Year 07 Month 10 Day
Anticipated trial start date
2017 Year 08 Month 18 Day
Last follow-up date
2018 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Measurement of infant skin condition

Management information
Registered date
2017 Year 07 Month 19 Day
Last modified on
2019 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032372

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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