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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037171
Receipt No. R000042354
Scientific Title Research on the relationship between UV-induced skin damage and ultraweak photon emission in the skin (2nd)
Date of disclosure of the study information 2019/06/28
Last modified on 2020/10/02

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Basic information
Public title Research on the relationship between UV-induced skin damage and ultraweak photon emission in the skin (2nd)
Acronym Study for evaluation of UV-induced skin damage
Scientific Title Research on the relationship between UV-induced skin damage and ultraweak photon emission in the skin (2nd)
Scientific Title:Acronym Study for evaluation of UV-induced skin damage
Region
Japan

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

Objectives
Narrative objectives1 To confirm the relationship between UV-induced skin damage and ultraweak photon emission in the skin
Basic objectives2 Others
Basic objectives -Others Development of evaluation method
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of the intensity of ultraweak photon emission and skin color just after and one day after UV irradiation, respectively
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 Diagnosis
Type of intervention
Other
Interventions/Control_1 Conduct single UV irradiation to the four different areas on inner upper arm at different energy doses
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
Key inclusion criteria Healthy males
Key exclusion criteria -Subjects with skin troubles in the measuring site
-Subjects who may cause an abnormal response to the light
-Smokers
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Daiki
Middle name
Last name Murase
Organization Kao Corporation
Division name Biological Science Research
Zip code 250-0002
Address 5-3-28, Kotobuki-cho, Odawara-shi,
TEL +81-465-34-6116
Email murase.daiki@kao.com

Public contact
Name of contact person
1st name Yu
Middle name
Last name Gabe
Organization Kao Corporation
Division name Biological Science Research
Zip code 250-0002
Address 5-3-28, Kotobuki-cho, Odawara-shi,
TEL +81-465-34-6116
Homepage URL
Email gabe.yu@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 +81-3-5630-9220
Email uesaka.toshio@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(神奈川県)

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 28 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 10
Results
The amount of UV-induced long-lasting ultraweak photon emission was highly correlated with the intensity of cutaneous redness 24 hours after UV exposure.
Results date posted
2020 Year 10 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Helthy male
Participant flow
Recruitment>Enrollment>Participation
Adverse events
None
Outcome measures
Evaluation of the intensity of ultraweak photon emission and skin color just after and one day after UV irradiation, respectively
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2019 Year 04 Month 16 Day
Date of IRB
2019 Year 04 Month 16 Day
Anticipated trial start date
2019 Year 06 Month 28 Day
Last follow-up date
2019 Year 07 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 25 Day
Last modified on
2020 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042354

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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