UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023128 |
|---|---|
| Receipt number | R000026661 |
| Scientific Title | Use test of sanitary goods (300516) |
| Date of disclosure of the study information | 2016/07/15 |
| Last modified on | 2017/05/15 07:48:18 |
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Basic information
Public title
Use test of sanitary goods (300516)
Acronym
Use test of sanitary goods
Scientific Title
Use test of sanitary goods (300516)
Scientific Title:Acronym
Use test of sanitary goods
Region
| Japan |
Condition
Condition
Healthy infants.
Classification by specialty
| Dermatology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of influence with skin by using of sanitary goods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of skin condition by doctor (using the skin rash score diagnosis)
, stratum corneum water content, the transepidermal water loss and the skin pH after 2 and 3 weeks using sanitary goods(300516).
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
1. Subjects use the sanitary goods(300516) for 2 and also 3 weeks. Before use and after using 2 and 3 weeks, skin check and skin property measurements are performed.
2. Subjects indicate the use situation and the behavior when using sanitary goods(300516) on diary.
3. After using the sanitary goods in 3 weeks, subjects use the designated sanitary goods for 3 weeks and indicate the skin condition on diary.
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
| 12 | months-old | <= |
Age-upper limit
| 36 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
1. The infant who has become "skin trouble" so far or the infant who has the consciousness that a guardian says "It's easy to become skin trouble".
2. A guardian changes a diaper by herself mainly.
3. To participate in measurement during the investigation period.
Key exclusion criteria
1. Infant with chronic sickness.
2. Infant with the severe skin symptoms who needs treatment of an atopic dermatitis et al.
3. The infant infected with a disease of infectibility disease.
4. The infant who judged that a test doctor in attendance was unsuitable as a test participant.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Tyoshima |
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
0285-68-7432
toyoshima.yasuo@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Fukuda |
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
0285-68-7327
Homepage URL
fukuda.yuuko1@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
新横浜スキンラボセンタ（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 15 | 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 | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 17 | 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 | 07 | Month | 12 | Day |
Last modified on
| 2017 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026661
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
