UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051803 |
|---|---|
| Receipt number | R000059118 |
| Scientific Title | A study to evaluate the effect after using baby diaper,XIII |
| Date of disclosure of the study information | 2023/08/02 |
| Last modified on | 2026/04/06 14:27:00 |
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Basic information
Public title
A study to evaluate the effect after using baby diaper
Acronym
A study to evaluate the effect after using baby diaper
Scientific Title
A study to evaluate the effect after using baby diaper,XIII
Scientific Title:Acronym
A study to evaluate the effect after using baby diaper
Region
| Japan |
Condition
Condition
Healthy baby
Classification by specialty
| Dermatology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the dermatological effect after using baby diaper
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin condition before the use of test diaper, after 2 weeks.
Key secondary outcomes
- inflammatory cytokine
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use the test diaper for 14 days.
Interventions/Control_2
Use the control diaper for 14 days.
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
| 3 | months-old | <= |
Age-upper limit
| 10 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
1. 3 to 10 months living in Japan (Honshu) (4-9kg) Japanese infant
2. Infants who use tape-type S size diaper or M size diaper diaper all day.
3. Infants whose parents admit that they are worried about diaper dermatitis.
Key exclusion criteria
1. Infants who are under medical treatment or on medication for skin trouble.
2. Infants who were diagnosed with any disease among chronic disease and congenital disorder.
3. Infants who were affected with infectious disorder from one month before the start of the test to the start of the test.
4. Infants who used antibiotics, steroids, from one month before the start of the test to the start of the tes
5. Infants with skin disease on the diaper covering (up to moderate diaper dermatitis is not excluded).
6. Infants who had diarrhea from 1 week before the start of the study to the start of the study.
7. An infant whose head is not fully upright.
8. Infants judged by the researcher to be unsuitable for study participants.
Target sample size
77
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Fukuda |
Organization
Kao Corporation
Division name
Sanitary Products Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7428
fukuda.yuuko1@kao.com
Public contact
Name of contact person
| 1st name | Sanae |
| Middle name | |
| Last name | Sagara |
Organization
Kao Corporation
Division name
Sanitary Products Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7428
Homepage URL
sagara.sanae@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
+81-3-5630-9064
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 02 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
84
Results
In controlled trial of infants with high diaper rash scores test diaper group showed reduced perianal rash severity and improved skin after 2 weeks IL 1 alpha decreased with rash improvement Control diaper group showed little change after 2 weeks Infants with low rash scores were controls but rash worsened before control diaper use considered common variation Rash severity and IL 1 alpha changes corresponded Results suggest association between infant diaper rash and inflammatory cytokines
Results date posted
| 2026 | Year | 04 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The plan was to target 90 infants and 84 participants were obtained at the beginning of the study Three dropped out for their own reasons and the number of participants at the end of this study was 81 Participants at the end of this study 81 infants Mean age 5 point 6 months range 1 to 10 months 40 boys and 41 girls
Participant flow
Participants were recruited from monitors infants and their parents registered with the research company Screening Parents took pictures of the infant diaper skin after using the current Merries diaper and investigators evaluated the rash and selected participants for the trial Trial Participants were divided into 2 test groups and a control group 2 test groups 2 week use test of test diaper or control diaper A control group 2 week use test of control diaper Assessments before and after 2 weeks of use for each diaper to be conducted
Adverse events
None
Outcome measures
Determination of rash by dermatologists on diaper skin pictures taken by parents, Analysis of inflammatory cytokines in the stratum corneum, Diary of diaper use, Questionnaire on diaper use experience
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 30 | 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 | 08 | Month | 02 | Day |
Last modified on
| 2026 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059118
