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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039154
Receipt No. 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

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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
Email 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
Email kawai.tomomitsu@kao.com

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 Human Research Ethics Committee, Kao Corporation
Address 2-1-3,Bunka,Sumida-ku,Tokyo, 131-8501, JAPAN
Tel +81-3-5630-7263
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044588

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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