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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023128
Receipt No. 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

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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
Email 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
Email fukuda.yuuko1@kao.co.jp

Sponsor
Institute Kao Corporation
Institute
Department

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
Email

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
URL(English) https://upload.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


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