UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025013
Receipt number 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 15:42:14

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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 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


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

Value
https://center6.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