UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038153 |
|---|---|
| Receipt number | R000043492 |
| Scientific Title | A Study on the association with allergen, a stimulant and skin condition of babies. |
| Date of disclosure of the study information | 2019/10/09 |
| Last modified on | 2020/03/31 13:07:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Study on the association with allergen, a stimulant and skin condition of babies.
Acronym
A Study on the association with allergen, a stimulant and skin condition of babies.
Scientific Title
A Study on the association with allergen, a stimulant and skin condition of babies.
Scientific Title:Acronym
A Study on the association with allergen, a stimulant and skin condition of babies.
Region
| Japan |
Condition
Condition
Healthy babys
Classification by specialty
| Pediatrics | Dermatology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify the association with allergen, a stimulant and skin condition of babies.
Basic objectives2
Others
Basic objectives -Others
Survey on actual condition
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Association with allergens and other stimulants and skin condition
Key secondary outcomes
-Total weight, classification and ingredient analysis of allergens and other stimulants
-Association with questionnaire items and skin condition
-Association with questionnaire items and allergens and other stimulants
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
| 10 | months-old | <= |
Age-upper limit
| 14 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
- The babies who use a paper diaper
- The babies who go to bed with futon for adults
Key exclusion criteria
- The baby having a serious disease to need treatment
- The baby who is infected with an infectious disease
- The baby who have loose bowels on a day to perform the diagnosis by the doctor and skin observation or is easy to have loose bowels routinely
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Tojo |
Organization
Kao Corporation
Division name
Skin Care Products Research Laboratory
Zip code
1318501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, Japan 1318501
TEL
+81-3-5630-9557
tojo.kaori@kao.com
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Haketa |
Organization
Kao Corporation
Division name
Skin Care Products Research Laboratory
Zip code
1318501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, Japan 1318501
TEL
+81-3-5630-7286
Homepage URL
haketa.noriko@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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9861
morisaki.naoko@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
株式会社インフォワード（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 09 | 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
| 2019 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Verify the association with allergen, a stimulant and skin condition of babies.
Management information
Registered date
| 2019 | Year | 09 | Month | 30 | Day |
Last modified on
| 2020 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043492
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
