UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037171 |
|---|---|
| Receipt number | 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 09:09:04 |
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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
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
gabe.yu@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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042354
