UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021710 |
|---|---|
| Receipt number | 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 10:36:35 |
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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
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
hotta.mitsuyuki@kao.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025046
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
