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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Healthy adults | ||
Classification by specialty |
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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 | |
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Interventions/Control_8 | |
Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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 |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
inomata.yukio@kao.com |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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. |
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Results date posted |
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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 |
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Plan to share IPD | |||||||
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
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Other | |
Other related information | The cumulative light exposure used for grouping was calculated from a questionnaire. |
Management information | |||||||
Registered date |
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Last modified on |
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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 |