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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025013
Receipt No. R000028784
Scientific Title An exploratory study of noninvasive aging index of epidermis.
Date of disclosure of the study information 2016/11/28
Last modified on 2017/11/09

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Basic information
Public title An exploratory study of noninvasive aging index of epidermis.
Acronym An exploratory study of noninvasive aging index of epidermis.
Scientific Title An exploratory study of noninvasive aging index of epidermis.
Scientific Title:Acronym An exploratory study of noninvasive aging index of epidermis.
Region
Japan

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

Objectives
Narrative objectives1 To establish noninvasive aging index of epidermis.
Basic objectives2 Others
Basic objectives -Others To establish noninvasive aging index of epidermis.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes - Relation between the properties of the auto-fluorescence emitted from epidermis with age
- Relation between the optical properties (scattering, absorbance) of skin with age
- Relation between the morphological characteristic of skin surface with age
- Relation between the trace component on skin surface with age.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Measure the noninvasive aging indexes of epidermis to 20's age volunteers.
Interventions/Control_2 Measure the noninvasive aging indexes of epidermis to 60's age volunteers.
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
69 years-old >=
Gender Female
Key inclusion criteria -Healthy female in 20's and 60's age groups.
Key exclusion criteria -Subjects with cutaneous symptoms of atopic dermatitis
-Subjects regularly going to hospital for sickness and/or who are taking OTC or prescription medicine
-Subjects undergoing hormone therapy
-Subjects with smoking habit
-Subjects with clinically-significant disorder (eczema, a scratch etc.) at the sites to be studied
- Subjects with excess sunburn at the test site
- Subjects who are pregnant or had a baby within one year.
-Subjects deemed inappropriate to participate in this study by the principle investigator.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takatoshi Murase
Organization Kao Corporation
Division name R&D -Core Technology- Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7871
Email murase.takatoshi@kao.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiichi Sugata
Organization Kao Corporation
Division name R&D -Core Technology- Biological Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7872
Homepage URL
Email sugata.keiichi@kao.co.jp

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
Address
Tel
Email

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(栃木県)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 28 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
2016 Year 11 Month 16 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 28 Day
Last modified on
2017 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028784

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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