UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025941
Receipt number R000029788
Scientific Title A clinical survey of atopic dermatitis patients.
Date of disclosure of the study information 2017/02/18
Last modified on 2017/07/19 10:50:33

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Basic information

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

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

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


Public contact

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


Sponsor or person

Institute

Shiba Palace Clinic

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

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


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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name