UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical survey of atopic dermatitis patients.
Title of the study (Brief title)	A clinical survey of atopic dermatitis patients.
Region	Japan

Condition
Condition	Atopic dermatitis
Classification by specialty	Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the utility of various measurement values as the state of atopic dermatitis.
Basic objectives2	Others
Basic objectives -Others	Clinical survey (the skin statement of atopic dermatitis patients and healthy subjects)
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Instrument measurement values (Transepidermal water loss, water content of the stratum corneum, erythema and pigmentation, etc.)
Key secondary outcomes	Questionnaires for QOL assessment

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	20 years-old <=
Age-upper limit	49 years-old >=
Gender	Male and Female
Key inclusion criteria	A. Inclusion criteria of healthy subjects 1) healthy subjects 2) Subjects who agree with the joining this study based on the consent by the document B) Inclusion criteria of atopic dermatitis patients 1) Patients with atopic dermatitis 2) Patients with mild or moderate rash on the forearm and the cubital fossa 3) Patients who use topical steroid on both arms 4) Patients with narrow area of rash on the hands 5) Patients who agree with the joining this study based on the consent by the document
Key exclusion criteria	A. Exclusion criteria of healthy subjects 1) Subjects with allergic disease such as asthma and atopic dermatitis 2) Subjects with any complications which affect the results of this study 3) Subjects with difficulty of blood collection 4) Subjects with smoking habit 5) Subjects with severe sunburn on both arms 6) Subjects deemed inappropriate to participate in this study by the principal investigator or the sub-investigators B. Exclusion criteria of atopic dermatitis patients 1) Patients who use oral steroid 2) Subjects with allergic disease such as asthma 3) Patients with any complications which affect the results of this study 4) Patients with difficulty of blood collection 5) Patients with smoking habit 6) Patients with severe sunburn on both arms 7) Patients deemed inappropriate to participate in this study by the principal investigator or the sub-investigators
Target sample size	45

Research contact person
Name of lead principal investigator	Takashi Koikeda
Organization	Shiba Palace Clinic
Division name	Chief of Clinic
Address	DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL	03-5408-1599
Email	jimukyoku@mail.souken-r.com

Public contact
Name of contact person	Reiko Maruya
Organization	SOUKEN CO., LTD
Division name	clinical laboratory management
Address	DaiwaA Hamamatsucho Bldg. 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL	03-5408-1555
Homepage URL
Email	r_maruya@mail.souken-r.com

Sponsor
Institute	Shiba Palace Clinic
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	芝パレスクリニック（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 27 Day
Anticipated trial start date	2017 Year 02 Month 19 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	In the treatment of atopic dermatitis, it is important to assess the pathological condition accurately. Subjective means such as inspection and palpation are popular approach for assess the skin statement of atopic dermatitis, but objective means are also important. It is necessary to digitizing the skin statement of atopic dermatitis to assess it objectively. Subjects are recruited among enrolled tester in SOUKEN CO.,LTD. on website.

Management information
Registered date	2017 Year 02 Month 01 Day
Last modified on	2017 Year 07 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029788