UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040443 |
|---|---|
| Receipt number | 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 11:19:35 |
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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
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
takeda.katsuya@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
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046160
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