UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021767 |
|---|---|
| Receipt number | R000025101 |
| Scientific Title | Analysis study of factors implicated in skin trouble on infants. |
| Date of disclosure of the study information | 2016/04/04 |
| Last modified on | 2019/11/21 08:40:59 |
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Basic information
Public title
Analysis study of factors implicated in skin trouble on infants.
Acronym
Analysis study of factors implicated in skin trouble on infants.
Scientific Title
Analysis study of factors implicated in skin trouble on infants.
Scientific Title:Acronym
Analysis study of factors implicated in skin trouble on infants.
Region
| Japan |
Condition
Condition
Healthy infants
Classification by specialty
| Dermatology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identification of factors implicated in skin trouble.
Basic objectives2
Others
Basic objectives -Others
Identification of factors implicated in skin trouble.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Screen subjects from each group of skin trouble-susceptible infants and non-susceptible infants based on medical questionnaire and diagnosis. Then, perform composition analysis of stratum corneum and feces of them.
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
-Diagnosis of skin symptom.
-Composition analysis of stratum corneum.
-Analysis of resident skin bacteria.
-Composition analysis of feces and saliva.
-Questionnaire survey about lifestyle and constitution.
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
| 8 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
-Infant with use of disposable diaper.
-Healthy infant without any disorder outside of skin.
-Both infants likely to develop skin trouble and infants unlikely to develop skin trouble.
Key exclusion criteria
-Infants with chronic disorder.
-Infants with serious skin symptom requiring treatment.
-Infants with infectious disorder.
-Infants deemed inappropriate to participate in this study by the physician-in-charge.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoko Baba |
Organization
Kanagawa Children's Medical Center
Division name
Department of dermatology
Zip code
Address
4-1124-2 Mutsukawa, Minami-ku, Yokohama, Kanagawa, Japan 232-0066
TEL
045-711-2351
nbaba@kcmc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Honda |
Organization
DRC Co., Ltd.
Division name
Evaluation Center
Zip code
Address
2-6 Koubaicho, Kita-ku, Osaka, Japan 530-0038
TEL
06-6882-1130
Homepage URL
honda@drc-web.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
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
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
| 2016 | Year | 04 | Month | 04 | 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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For the purpose of identification of factors implicated in skin trouble, recruit skin trouble-susceptible infants and non-susceptible infants by 30 (total 60 infants).
Management information
Registered date
| 2016 | Year | 04 | Month | 04 | Day |
Last modified on
| 2019 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025101
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
