UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034693 |
|---|---|
| Receipt number | R000039347 |
| Scientific Title | A study for the skin function |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2019/01/16 18:28:14 |
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Basic information
Public title
A study for the skin function
Acronym
A study for the skin function
Scientific Title
A study for the skin function
Scientific Title:Acronym
A study for the skin function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparing the relationship between skin microcirculation function and epidermal metabolism
Basic objectives2
Others
Basic objectives -Others
Comparing the relationship between skin microcirculation and epidermal metabolism
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Statistically evaluate the relationship between skin microcirculation function and skin epidermal metabolism
Key secondary outcomes
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
| 40 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
1. healthy male aged from 40 to 59 years old
2. can participate in this examination during the period
3. can acquired consent by written document based on his own intention before commencement of the examination
4. do not have trouble on the skin of the measurement region (upper arm)
5. can approve to prohibit depilation or depilation of the measurement region during the period from the start to the end of the test
6. can acknowledge not to excessive sunburn of the measurement region
Key exclusion criteria
1. has abnormalities in the skin of the measurement region (upper arm)
2. regularly goes to hospital
3. has atopic dermatitis and possibilities for emerging allergy to cosmetics
4. has clear sunburn at the measurement region on the day of the test
5. has allergy to adhesive tape and/or medical tape.
6. photosensitivity
7. are participating in the examination with the measurement region
8. smoker
9. has serious diseases (hypertension, heart disease, liver disease, diabetes).
10. poor physical condition.
11. taking medicine
12. participate in other human tests (all tests for humans using cosmetics, foods, medicines, quasi-drugs, medical devices) within the past 4 weeks
13. patient with vascular function disorder, or person who has excessive sensitivity to cold
14. subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanori Tanahashi |
Organization
Kao Corporation
Division name
R&D Skin Care Products Research
Zip code
Address
5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, Japan
TEL
0465-35-3175
tanahashi.masanori@kao.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiko Oharazawa |
Organization
Kao Corporation
Division name
R&D Skin Care Products Research
Zip code
Address
5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, Japan
TEL
0465-35-3175
Homepage URL
oharazawa.akihiko@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
Address
Tel
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（小田原）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 11 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Statistically evaluate the relationship between skin microcirculation function and skin epidermal metabolism
Management information
Registered date
| 2018 | Year | 10 | Month | 30 | Day |
Last modified on
| 2019 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039347
