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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040443
Receipt No. R000046160
Scientific Title An observational study of photoaging 2018.5
Date of disclosure of the study information 2020/06/01
Last modified on 2020/05/19

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Basic information
Public title An observational study of photoaging 2018.5
Acronym An observational study of photoaging 2018.5
Scientific Title An observational study of photoaging 2018.5
Scientific Title:Acronym An observational study of photoaging 2018.5
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This is a survey to observe the skin property of healthy women in her 20s. The subjects are divided 2 groups different about the amount of cumulative light exposure. Furthermore, it investigates the relation with the actual feeling and consciousness.
Basic objectives2 Others
Basic objectives -Others An observational test
Trial characteristics_1
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Visual score
Ultraweak photon emissions in the skin
Stratum corneum water content
Transepidermal water loss
Stratum corneum flexibility
Skin viscoelasticity
Skin color
Intercellular lipid packing
Skin shape
Amount of sebum, composition of sebum
Composition of stratum corneum protein
Key secondary outcomes Questionnaire of skin consciousness

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
29 years-old >=
Gender Female
Key inclusion criteria Healthy females in her 20s living near Tokyo
Subjects who have no medical condition at the test site.
Subjects who can cooperate with measurement and photograph.
Subjects with un-smoking.
Subjects who (or whose family member) are not working for other companies in the same industry
Subjects who can understand the risk of UV irradiation of this test.
Subjects who can fully understand the contents of this test.
Key exclusion criteria Subjects with abnormal skin on the test site
Subjects who go to medical institution with skin disease
Subjects with atopic skin or skin that is prone to cosmetic trouble
Subjects taking drugs that affect photosensitivity
Subjects who have had abnormal reactions to sunlight
Subjects with phobia of the dark or closed place
Subjects who may be pregnancies during the study period
Subjects who may lactate during the study period.
Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Yukio
Middle name
Last name Inomata
Organization Kao Corporation
Division name Skincare Research
Zip code 250-0002
Address 5-3-28, Kotobuki-cho, Odawara-city, Kanagawa, 250-0002, JAPAN
TEL +81-465-34-6053
Email inomata.yukio@kao.com

Public contact
Name of contact person
1st name Katsuya
Middle name
Last name Takeda
Organization Kao Corporation
Division name Skincare Research
Zip code 131-8501
Address 2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, Japan
TEL +81-3-5630-9258
Homepage URL
Email takeda.katsuya@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 Market Development Research
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 06 Month 01 Day

Related information
URL releasing protocol None
Publication of results Unpublished

Result
URL related to results and publications None
Number of participants that the trial has enrolled 40
Results Measurements were performed in the high and low UV exposure groups. As a result, it was confirmed that there were significant differences in pore area, stratum corneum water content, intercellular lipid structure, etc. between the groups. It was also found that there is a difference between the groups about ultraweak photon emission.
From these results, it was suggested that skin changes caused by photoaging can be evaluated by these measurements.
Results date posted
2020 Year 05 Month 19 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Healthy adults
Participant flow Recruiting>Survey
Adverse events None
Outcome measures Visual score
Ultraweak photon emissions in the skin
Stratum corneum water content
Transepidermal water loss
Stratum corneum flexibility
Skin viscoelasticity
Skin color
Intercellular lipid packing
Skin shape
Amount of sebum, composition of sebum
Composition of stratum corneum protein
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 02 Month 26 Day
Date of IRB
2018 Year 02 Month 26 Day
Anticipated trial start date
2018 Year 05 Month 16 Day
Last follow-up date
2018 Year 06 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 07 Month 31 Day

Other
Other related information The cumulative light exposure used for grouping was calculated from a questionnaire.

Management information
Registered date
2020 Year 05 Month 19 Day
Last modified on
2020 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046160

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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