UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050694 |
|---|---|
| Receipt number | R000057756 |
| Scientific Title | The study on changes in infant skin condition due to the use of a sebum RNA mailing test kit |
| Date of disclosure of the study information | 2023/04/05 |
| Last modified on | 2024/10/01 11:36:49 |
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Basic information
Public title
The study on changes in infant skin condition due to the use of a sebum RNA mailing test kit
Acronym
The study on changes in infant skin condition due to the use of a sebum RNA mailing test kit
Scientific Title
The study on changes in infant skin condition due to the use of a sebum RNA mailing test kit
Scientific Title:Acronym
The study on changes in infant skin condition due to the use of a sebum RNA mailing test kit
Region
| Japan |
Condition
Condition
Healthy infants
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To verify the skin condition at 7 months old when subjects use sebum RNA kits and performed skin care according to the advice.
2) To verify the relationship between sebum RNA and skin conditions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in skin condition based on UKWP (The U.K. Working Party) at 7 months old
Key secondary outcomes
1. Relationship between sebum RNA and skin conditions at one month old and 7 months old
2. Relationship between sebum RNA and questionnaire at one month old and 7 months old
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
1.Use the skin barrier test "Babiwell Check" and perform skin care based on the test results at one month old.
2.Watch the video and the flyer about skin care at 4 months old.
3.Use the skin barrier test "Babiwell Check" at 7 months old.
Interventions/Control_2
1.Use the skin barrier test "Babiwell Check" at 7 months old.
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
| 1 | months-old | <= |
Age-upper limit
| 7 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Persons whose legally authorized representative received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Infants aged one month old (intervention group) or 7 months old (non-intervention group) at the time of the preintervention test.
Key exclusion criteria
1.Persons who were judged as inappropriate for study participants by the principal investigators.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Asahina |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
asahina.yuki@hc-sys.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Asahina |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
asahina.yuki@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Healthcare Systems Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Gamagori City Hospital
Name of secondary funder(s)
Kao Corporation
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel
052-734-8885
soumu@hc-sys.jp
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
| 2023 | Year | 04 | Month | 05 | 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
125
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
| 2023 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 28 | Day |
Last modified on
| 2024 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057756
