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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017761
Receipt No. R000020331
Scientific Title A Study on Successful Maintenance for Atopic Dermatitis
Date of disclosure of the study information 2015/06/01
Last modified on 2017/05/24

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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.
ï½¥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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