UMIN-CTR Clinical Trial

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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