UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059207 |
|---|---|
| Receipt number | R000067719 |
| Scientific Title | Study on promoting caregiver behavior change to protect infant skin barrier |
| Date of disclosure of the study information | 2025/09/26 |
| Last modified on | 2025/09/26 17:00:13 |
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Basic information
Public title
Study on promoting caregiver behavior change to protect infant skin barrier
Acronym
Infant study
Scientific Title
Study on promoting caregiver behavior change to protect infant skin barrier
Scientific Title:Acronym
Infant study
Region
| Japan |
Condition
Condition
Skin barrier
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is known that skin condition changes as people grow, and infant skin is immature and fragile, with particularly weak barrier function and differing levels of stratum corneum factors. Therefore, our company aims to examine whether assessing and providing information about skin condition from infancy can contribute to the protection of the skin barrier, and to explore its practical application.
Basic objectives2
Others
Basic objectives -Others
It is known that skin condition changes as people grow, and infant skin is immature and fragile, with particularly weak barrier function and differing levels of stratum corneum factors. Therefore, our company aims to examine whether assessing and providing information about skin condition from infancy can contribute to the protection of the skin barrier, and to explore its practical application.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in awareness over the course of the survey: at the start, after one month, and at the end.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Seminar participation and stratum corneum sampling
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
| 2 | months-old | <= |
Age-upper limit
| 12 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy infants aged 2 to 11 months living in Japan (regardless of nationality) and their caregivers.
Key exclusion criteria
Infants with allergic conditions such as atopic dermatitis or food allergies at the time of the study
Infants currently taking medication, or those who require or are scheduled to require regular medication
Infants with noticeable skin issues, wounds, scars, swelling (e.g., from bruises), or skin disorders on the test area (cheeks to around the mouth)
Infants who are currently experiencing excessive sunburn or are expected to engage in activities during the study period that may cause excessive sun exposure (e.g., swimming in the ocean, mountain climbing, sunbathing, skiing)
Infants currently participating in other studies involving medical products, pharmaceuticals, cosmetics, or food intake, or scheduled to participate during the study period
Any other individuals deemed unsuitable for participation by the principal investigator or co-investigators
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Chieko |
| Middle name | |
| Last name | Okamura |
Organization
SHISEIDO
Division name
BCTC
Zip code
220-8559
Address
1-2-11 Takashima, Nishi-ku, Yokohama City
TEL
07038591347
chieko.okamura@shiseido.com
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Onodera |
Organization
SHISEIDO
Division name
BCTC
Zip code
220-8559
Address
1-2-11 Takashima, Nishi-ku, Yokohama City
TEL
07038591348
Homepage URL
tomoko.onodera@shiseido.com
Sponsor or person
Institute
SHISEIDO
Institute
Department
Personal name
Funding Source
Organization
SHISEIDO
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
SHISEIDO
Address
1-2-11 Takashima, Nishi-ku, Yokohama City
Tel
07038591348
tomoko.onodera@shiseido.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 26 | Day |
Last modified on
| 2025 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067719
