UMIN-CTR Clinical Trial

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

Objectives
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

Assessment
Primary outcomes	The rate of the maintenance phase of Atopic Dermatitis(time to recurrence of inflammation)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	Non-Profit Organization Health Institute Research of Skin
Institute
Department

Funding Source
Organization	Glaxo Smith Kline K.K.
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

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

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	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
Other related information

Management information
Registered date	2015 Year 06 Month 01 Day
Last modified on	2017 Year 05 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020331

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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