UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	skin measurement by Raman spectrometer
Title of the study (Brief title)	skin measurement by Raman spectrometer
Region	Japan

Condition
Condition	atopic dermatitis
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the distribution of natural moisturaizing factor of amino acid after skin-care
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the distribution of natural moisturaizing factor, amino acid, lipid
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	Treatment
Type of intervention	Other
Interventions/Control_1	cosmetics
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	Not applicable
Gender	Male and Female
Key inclusion criteria	atopic dermatitis
Key exclusion criteria	systemic steroid, immunosuppressive agent,pregnancy
Target sample size	6

Research contact person
Name of lead principal investigator	KenjiKabashima
Organization	Kyoto University Hospital
Division name	dermatology
Address	54 Kawhara-cho Shogoin Sakyo-ku Kyoto-shi Japan
TEL	075-751-3605
Email	kaba@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	ChisaNakashima
Organization	Kyoto University Hospital
Division name	Dermatology
Address	54 Kawhara-cho Shogoin Sakyo-ku Kyoto-shi Japan
TEL	0757513605
Homepage URL
Email	chisa313@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Hospital
Institute
Department

Funding Source
Organization	Shiseido
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

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 31 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date	2016 Year 08 Month 31 Day
Date of closure to data entry	2016 Year 08 Month 31 Day
Date trial data considered complete	2016 Year 08 Month 31 Day
Date analysis concluded	2016 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	No obvious changes in the amount of natural moisturizing factor, amino acid and lipid in stratum corneum due to the application were observed.
Other related information

Management information
Registered date	2015 Year 09 Month 03 Day
Last modified on	2017 Year 09 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021777