UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026877 |
|---|---|
| Receipt number | R000030837 |
| Scientific Title | Use test of skin care goods |
| Date of disclosure of the study information | 2017/04/05 |
| Last modified on | 2017/04/05 17:52:08 |
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Basic information
Public title
Use test of skin care goods
Acronym
Use test of skin care goods
Scientific Title
Use test of skin care goods
Scientific Title:Acronym
Use test of skin care goods
Region
| Japan |
Condition
Condition
Healthy infants
Classification by specialty
| Dermatology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the combination skin care consists of foamed body cleanser and moisturizer (lotion or cream) on infant skin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of skin symptoms by dermatological diagnosis before and after the topical application of 4 weeks
Key secondary outcomes
Change of water content, transepidermal water loss, skin pH and composition of stratum corneum before and after the topical application for 4 weeks
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
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 foaming cleanser and lotion every single day for 4 weeks
Interventions/Control_2
Use the foaming cleanser and cream every single day for 4 weeks
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
-Infants with use of disposable diaper
-Healthy infant without any disorder outside of skin
-Infants with insignificant levels of dry skin
Key exclusion criteria
-Infants with chronic disorder
-Infants with serious skin symptom requiring treatment
-Infants with infectious disorder
-infants deemed inappropriate to participate in this study by physician-in-charge
-Infants with diarrhea during screening
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Mizushima |
Organization
Kao Corporation
Division name
R&D -Development Research- Skin Care Products Research
Zip code
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL
03-5630-9580
mizushima.hiroki@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoko Okamoto |
Organization
Kao Corporation
Division name
R&D -Development Research- Skin Care Products Research
Zip code
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL
03-5630-9580
Homepage URL
okamoto.naoko@kao.co.jp
Sponsor or person
Institute
DRC Co.LTD
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ー（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 05 | 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
| 2015 | Year | 02 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 22 | 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
| 2017 | Year | 04 | Month | 05 | Day |
Last modified on
| 2017 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030837
