UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039154 |
|---|---|
| Receipt number | R000044588 |
| Scientific Title | Evaluation of moisturizing performance of topical product for massage. |
| Date of disclosure of the study information | 2020/04/30 |
| Last modified on | 2020/01/09 10:50:10 |
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Basic information
Public title
Evaluation of moisturizing performance of topical product for massage.
Acronym
Evaluation of moisturizing performance of topical product for massage.
Scientific Title
Evaluation of moisturizing performance of topical product for massage.
Scientific Title:Acronym
Evaluation of moisturizing performance of topical product for massage.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of moisturizing performance to skin horny cell layer of topical product for massage.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change rate of stratum corneum water content, before and after application of topical product.
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Apply once topical product at one side of the forearm inside, and control product at another side
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy males and females
Key exclusion criteria
-Individuals who have serious diseases such as heart, lung, kidney, liver, blood, endocrine, skin, etc.
-Subjects with atopic dermatitis, eczema and pollen allergy
-Pregnancies and lactations
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Miyuki |
| Middle name | |
| Last name | Hayama |
Organization
Kao Corporation
Division name
Hair Care Product Research
Zip code
131-8501
Address
2-1-3,Bunka,Sumida-ku,Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-9260
hayama.miyuki@kao.com
Public contact
Name of contact person
| 1st name | Tomomitsu |
| Middle name | |
| Last name | Kawai |
Organization
Kao Corporation
Division name
Hair Care Product Research
Zip code
131-8501
Address
2-1-3,Bunka,Sumida-ku,Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-9260
Homepage URL
kawai.tomomitsu@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
+81-3-5630-7263
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
花王株式会社（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 30 | 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
20
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
| 2019 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 12 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 12 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 19 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 14 | Day |
Last modified on
| 2020 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044588
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
