UMIN-CTR Clinical Trial

Public title

A Study on Successful Maintenance for Atopic Dermatitis

Acronym

SMART study

Scientific Title

A Study on Successful Maintenance for Atopic Dermatitis

Scientific Title:Acronym

SMART study

Region

Japan

Condition

atopic dermatitis

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This preliminary study aims to establish proactive treatment combined with oral antihistamine usage and topical agents usage by evaluating the usefullness of prophylactic antihistamines when added to on proactive treatment during the maintenance phase of Atopic Dermatitis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The rate of the maintenance phase
of Atopic Dermatitis(time to recurrence of inflammation)

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Proactive therapy with topical agents alone

Interventions/Control_2

Proactive therapy with topical agents plus an antihistamine (levocetirizine hydrochloride) at dose of 5mg once a day

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

16

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

The first stage
1) Patients who are diagnosed as AD
2) Patients with more than moderate AD (according to severity scoring by JDA) who are needed daily treatment of steroids and tacrolimus.
3) Patients who are obtainable written informed consent.
4) Patients with more than 16 years old who are diagnosed as AD.
･Should be obtained written informed consent by the legally authorized representative If he or she is less than 20 years old.
* moderate AD : according to severity scoring by Severity Score Index according to Standard guideline for management (authorized by Japanese Dermatological Association)
The second stage
1) Subjects who were registered in 1st phase, and also had the inflammation symptom subside within 4 weeks during the course of standard therapy defined in the JDA guideline.
2) Subjects who had recurrence of inflammation symptom will be receive the standard therapy defined in the JDA guideline again.
3) Patients who are obtainable written informed consent about the second stage investigation.
* should be obtained written informed consent by the legally authorized representative If he or she is less than 20 years-old.

Key exclusion criteria

The first stage
1) Patients who have the history of hypersensitivity to any of the study drug.
2) Women who are pregnant,delivery,
,location or person who hope the pregnancy of the partne..
3) Unsuitability as determined by the study doctor.
The second stage
1) Patients who have the history of hypersensitivity to any of the study drug.
2) Women who are pregnant,delivery,
,location or person who hope the pregnancy of the partne.
3) Unsuitability as determined by the study doctor.

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Makoto Kawashima

Organization

Tokyo Woman's Medical University

Division name

Department of Dermatology

Zip code

Address

8-1 Kawada-cho, Shinjyuku-ku, Tokyo, Japan

TEL

03-3353-8111

Email

m-kawash@derm.twmu.ac.jp

Name of contact person

1st name
Middle name
Last name	Yasunari Hiramatsu

Organization

Non-Profit Organization Health Institute Research of Skin

Division name

secretariat

Zip code

Address

FUKUDA BUILDING 2F 1-8-9, Uchikanda, choyoda-ku, Tokyo, Japan

TEL

03-3256-2575

Homepage URL

Email

info@npo-hifu.net

Institute

Non-Profit Organization Health Institute Research of Skin

Institute

Department

Personal name

Organization

Glaxo Smith Kline K.K.

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

Date of disclosure of the study information

2015

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Published

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

2014

Year

09

Month

11

Day

Date of IRB

Anticipated trial start date

2014

Year

11

Month

10

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

06

Month

01

Day

Last modified on

2017

Year

05

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020331