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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021710
Receipt No. R000025046
Scientific Title Investigation of infant Skin properties using spectroscopic method.
Date of disclosure of the study information 2016/04/06
Last modified on 2020/10/02

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Basic information
Public title Investigation of infant Skin properties using spectroscopic method.
Acronym Investigation of infant Skin properties using spectroscopic method.
Scientific Title Investigation of infant Skin properties using spectroscopic method.
Scientific Title:Acronym Investigation of infant Skin properties using spectroscopic method.
Region
Japan

Condition
Condition Infants who have skin trouble.
Classification by specialty
Dermatology Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Factorial study of skin trouble.
Basic objectives2 Others
Basic objectives -Others Case study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Observation and scoring of skin symptom's severity, and divide to two group, skin troubled group and non-troubled group by dermatologist, and conduct following evaluation.
1.Measurement of skin hydration, skin surface pH and other stratum corneum components.
2.Analysis of stratum corneum components and microflora.
Key secondary outcomes

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 Prevention
Type of intervention
Other
Interventions/Control_1 Observation and scoring of skin symptom's severity, and divide to two group, skin troubled group and non-troubled group by dermatologist, and conduct following evaluation.
1.Measurement of skin hydration, skin surface pH and other stratum corneum components.
2.Analysis of stratum corneum components and microflora.
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 months-old <=
Age-upper limit
6 months-old >=
Gender Male and Female
Key inclusion criteria -Japanese infants who are 4-6 months old age.
-Healthy infants.
-Infants whose gestational-age are 37-41 weeks
-infants whose parents agree with participation of the study.
Key exclusion criteria -Infants with presence of systemic illness for their body
-Infants under-medication for their skin troubles
-Infants with highly contagious skin trouble
-Infants who have given diagnosis of atopic character (atopic dry skin, atopic eczema) by dermatologist.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Mitsuyuki
Middle name
Last name Hotta
Organization Kao Corporation
Division name R&D -Development Research- Biological Science research
Zip code 321-3497
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7861
Email hotta.mitsuyuki@kao.co.jp

Public contact
Name of contact person
1st name Mitsuyuki
Middle name
Last name Hotta
Organization Kao Corporation
Division name R&D -Development Research- Biological Science research
Zip code 321-3497
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7861
Homepage URL
Email hotta.mitsuyuki@kao.co.jp

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
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 Human Research Ethics Committee, Kao Corporation
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
Tel 0285-68-7729
Email taguchi.hiroyuki@kao.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 花王株式会社栃木研究所(栃木)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 06 Day

Related information
URL releasing protocol None
Publication of results Unpublished

Result
URL related to results and publications None
Number of participants that the trial has enrolled 23
Results Properties,components,and bacterial flora of infant's skin with skin troubles were different from that of normal infant's skin.
Results date posted
2020 Year 10 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics None
Participant flow None
Adverse events None
Outcome measures None
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 02 Month 24 Day
Date of IRB
2016 Year 02 Month 24 Day
Anticipated trial start date
2016 Year 05 Month 31 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 04 Month 30 Day

Other
Other related information For the purpose of identification of factors implicated in skin trouble, recruit 10 each infants who have diaper dermatitis and don't have dermatitis (total 20 infants).

Management information
Registered date
2016 Year 03 Month 31 Day
Last modified on
2020 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025046

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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