UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032375 |
|---|---|
| Receipt number | R000036749 |
| Scientific Title | Study to evaluate the dermatological skin condition of babies (T01) |
| Date of disclosure of the study information | 2018/05/17 |
| Last modified on | 2018/10/30 11:25:58 |
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Basic information
Public title
Study to evaluate the dermatological skin condition of babies (T01)
Acronym
Study to evaluate the dermatological skin condition of babies (T01)
Scientific Title
Study to evaluate the dermatological skin condition of babies (T01)
Scientific Title:Acronym
Study to evaluate the dermatological skin condition of babies (T01)
Region
| Asia(except Japan) |
Condition
Condition
Healthy baby
Classification by specialty
| Dermatology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To know the dermatological skin condition in diaper area of babies
Basic objectives2
Others
Basic objectives -Others
Dermatological assessment in diaper area
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dermatological assessment in diaper area
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
| Not applicable |
Age-upper limit
| 2 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy baby
Key exclusion criteria
1.Babiess who have a skin trouble caused by allergy
2.Babiess who have atopic dermatitis
3.Babies who have trouble with their illness to the whole body
4.Babies who have applied medicine in the skin trouble
5.Babies who experience diarrhea
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toyoshima Haruko |
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
0285-68-7448
toyoshima.haruko@kao.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rinko Takagi |
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
0285-68-7448
Homepage URL
takagi.rinko@kao.com
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
Taipei Medical University
MITHRA BIOTECHNOLOGY
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
Taipei Medical University（台湾）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 17 | 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
| 2018 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To know the dermatological skin condition in diaper area of babies
Management information
Registered date
| 2018 | Year | 04 | Month | 25 | Day |
Last modified on
| 2018 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036749
