UMIN-CTR Clinical Trial

Public title

A clinical survey of atopic dermatitis patients.

Acronym

A clinical survey of atopic dermatitis patients.

Scientific Title

A clinical survey of atopic dermatitis patients.

Scientific Title:Acronym

A clinical survey of atopic dermatitis patients.

Region

Japan

Condition

Atopic dermatitis

Classification by specialty

Dermatology

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Takashi Koikeda

Organization

Shiba Palace Clinic

Division name

Chief of Clinic

Zip code

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

Name of contact person

1st name
Middle name
Last name	Reiko Maruya

Organization

SOUKEN CO., LTD

Division name

clinical laboratory management

Zip code

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

Institute

Shiba Palace Clinic

Institute

Department

Personal name

Organization

Kao Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

芝パレスクリニック（東京都）

Date of disclosure of the study information

2017

Year

02

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

12

Month

27

Day

Date of IRB

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

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.

Registered date

2017

Year

02

Month

01

Day

Last modified on

2017

Year

07

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029788