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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017536
Receipt No. R000019782
Scientific Title A study to evaluate the efficacy of proactive therapy with topical agents and antihistamines during the maintenance phase of atopic dermatitis.
Date of disclosure of the study information 2015/05/14
Last modified on 2017/06/07

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Basic information
Public title A study to evaluate the efficacy of proactive therapy with topical agents and antihistamines during the maintenance phase of atopic dermatitis.
Acronym A study to evaluate the efficacy of proactive therapy with topical agents and antihistamines during the maintenance phase of atopic dermatitis.
Scientific Title A study to evaluate the efficacy of proactive therapy with topical agents and antihistamines during the maintenance phase of atopic dermatitis.
Scientific Title:Acronym A study to evaluate the efficacy of proactive therapy with topical agents and antihistamines during the maintenance phase of atopic dermatitis.
Region
Japan

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

Objectives
Narrative objectives1 to evaluate the efficacy of a combination of proactive therapy with topical agents and prophylactic administration of antihistamines during the remission maintenance phase of treatment for atopic dermatitis, and to establish proactive therapy with a combination of topical agents and oral antihistamines.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Remission maintenance rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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 antihistamines.
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 1) Patients diagnosed with atopic dermatitis and who had moderate or severe atopic eczema in the recent 12 weeks.

2) Patients with less than mild score who are well controlled with standard therapy defined in the JDA guideline.
*controlled without steroids anc tacrolimus treatment.
*TARC level is less than 700pg/mL

3) Patients providing written consent after receiving explanation regarding the details of this study.

4) Patients aged 16 years or older at enrollment; for those under the age of 20 years, consent from their legal guardians (e.g., their parents) is required.
Key exclusion criteria 1) Patients who have the history of hypersensitivity to any of the study drug.

2) Pregnant or possibly pregnant women, or breastfeeding women. Women who wish to become pregnant during study participation.

3) Patients who are judged inappropriate to participate in the study by the investigator.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Kawashima
Organization Tokyo Woman's Medical University
(Non-Profit Organization Health Institute Research of Skin)
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 Naomi Kanazawa
Organization EBC&M LLC.
Division name Project planning & Development department
Zip code
Address CROSS OFFICE MITA 9F 5-29-20, Shiba, Minato-ku, Tokyo, Japan
TEL 03-6435-3833
Homepage URL
Email kanazawa@ebc-m.com

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

Funding Source
Organization Mitsubishi Tanabe Pharma 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

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 14 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 11 Month 18 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 23 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 05 Month 13 Day
Last modified on
2017 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019782

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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