UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for the skin function
Title of the study (Brief title)	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	Masanori Tanahashi
Organization	Kao Corporation
Division name	R&D Skin Care Products Research
Address	5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, Japan
TEL	0465-35-3175
Email	tanahashi.masanori@kao.com

Public contact
Name of contact person	Akihiko Oharazawa
Organization	Kao Corporation
Division name	R&D Skin Care Products Research
Address	5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, Japan
TEL	0465-35-3175
Homepage URL
Email	oharazawa.akihiko@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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 09 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039347