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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | atopic dermatitis | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
m-kawash@derm.twmu.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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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 |