UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063542 |
|---|---|
| Receipt number | R000072248 |
| Scientific Title | Utility of Baby Cream in the Diaper Area of Infants |
| Date of disclosure of the study information | 2026/11/06 |
| Last modified on | 2026/11/06 12:24:54 |
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Basic information
Public title
Utility of Baby Cream in the Diaper Area of Infants
Acronym
Utility of Baby Cream in the Diaper Area of Infants
Scientific Title
Utility of Baby Cream in the Diaper Area of Infants
Scientific Title:Acronym
Utility of Baby Cream in the Diaper Area of Infants
Region
| Japan |
Condition
Condition
Healty infant (History of diaper dermatitis)
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A randomized controlled trial will be conducted to determine whether a cream containing an ingredient -which has been shown in experiments to inhibit the cytotoxic substances produced by Anaerococcus vaginalis, a microorganism known to be associated with the onset of diaper dermatitis - is effective in preventing and improving diaper dermatitis in infants.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of Diaper Rash
Key secondary outcomes
Frequency and duration of diaper dermatitis episodes
Skin barrier function indicators (TEWL, stratum corneum moisture content, skin surface pH) and changes in these indicators
Parents' satisfaction with the cream, their perception of its effectiveness against diaper dermatitis, user experience, and parents' quality of life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Intervention group apply the cream containing the ingredients twice a day for two weeks.
Interventions/Control_2
the control group uses a placebo cream
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
| 6 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Infants who meet all of the following criteria will be included in the study.
1. The infant must be under 6 months of age at the time consent is obtained.
2. The infant must have both Japanese parents.
3. The study participant and their parent must be able to visit on all observation days.
4. The infant must have previously experienced redness on the buttocks.
(This refers to the parent' s perception that the infant has had diaper dermatitis; a formal diagnosis is not required, and the severity is irrelevant.)
Key exclusion criteria
1. Chronic or congenital conditions requiring ongoing medication
2. Infants diagnosed with atopic dermatitis who are undergoing treatment at the time of recruitment
3. Individuals who have refused to participate in this study or to have their information used
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Haruna |
Organization
The University of Tokyo
Division name
Department Midwifery and Women's Health
Zip code
1130033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5841-3396
boseikango@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | yonezawa |
Organization
The University of Tokyo
Division name
Department Midwifery and Women's Health
Zip code
1130033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5841-3396
Homepage URL
boseikango@m.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Unicharm 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
Office for Human Research Studies(OHRS), Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.ac.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
| 2026 | Year | 11 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2028 | Year | 03 | 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
| 2026 | Year | 11 | Month | 06 | Day |
Last modified on
| 2026 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072248
