UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to evaluate the efficacy of proactive therapy with topical agents and antihistamines during the maintenance phase of atopic dermatitis.
Title of the study (Brief title)	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	Makoto Kawashima
Organization	Tokyo Woman's Medical University (Non-Profit Organization Health Institute Research of Skin)
Division name	Department of Dermatology
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	Naomi Kanazawa
Organization	EBC&M LLC.
Division name	Project planning & Development department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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