UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021667 |
|---|---|
| Receipt number | R000024984 |
| Scientific Title | A study to evaluate the effect after using baby diaper |
| Date of disclosure of the study information | 2016/04/02 |
| Last modified on | 2017/04/07 08:20:22 |
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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
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
Dermatological assessment before and after using diaper for 2, 4 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Diaper(H) (2weeks)-> Diaper(T) (2weeks)
Interventions/Control_2
Diaper(T) (2weeks)-> Diaper(H) (2weeks)
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
| 24 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy baby
Key exclusion criteria
1.Babies who have chronic illness and congenital illness.
2.Babiess who have a skin trouble (atopic dermatitis, allergic dermatitis, psoriasis, critical ermatitis).
3.Babies who have applied going to hospital regularly, a therapy or medication, and medicine in the skin trouble.
4.Presence of systemic illness.
5.Babies who judged that an examination doctor in attendance was unsuitable.
6.Babies who experience diarrhea during screening.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toyoshima Haruko |
Organization
Kao Corporation
Division name
R&D -Development Research- Sanitary Products Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
0285-68-7448
toyoshima.haruko@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rinko Takagi |
Organization
Kao Corporation
Division name
R&D -Development Research- Sanitary Products Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
0285-68-7448
Homepage URL
takagi.rinko@kao.co.jp
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
Address
Tel
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
神奈川県立こども医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 02 | 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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 29 | Day |
Last modified on
| 2017 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024984
