UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Bleach bath therapy as a maintenance treatment of atopic dermatitis
Title of the study (Brief title)	Bleach bath therapy for atopic dermatitis
Region	Japan

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

Objectives
Narrative objectives1	to assess the efficacy of bleach bath therapy for long-term maintenance of atopic dermatitis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	a number of exacerbations, time to drop out (to evaluate the effectiveness of the intervention at 3 months)
Key secondary outcomes	SCORAD, serum TARC score, volume of steroid ointment use

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
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	to take 0.005% dose of sodium hypochlorite baths for 5-10 minutes, twice a week
Interventions/Control_2	to take "usual" baths for 5-10 minutes, twice a week
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	12 years-old <=
Age-upper limit	99 years-old >=
Gender	Male and Female
Key inclusion criteria	moderate to severe atopic dermatitis patients who are more than 12 years old.
Key exclusion criteria	pregnant and nursing patients, patients who wish to become pregnant patients who have severe disease patients who are sensitive to sodium hypochlorite patients who have a history of malignant tumor without carcinoma in situ
Target sample size	50

Research contact person
Name of lead principal investigator	Tamotsu Ebihara
Organization	Keio university school of medicine
Division name	Department of dermatology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211(62413)
Email	ebitamo@yahoo.co.jp

Public contact
Name of contact person	Tamotsu Ebihara
Organization	Keio university school of medicine
Division name	Department of dermatology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211(62413)
Homepage URL
Email	ebitamo@yahoo.co.jp

Sponsor
Institute	Keio university school of medicine, Department of dermatology
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tokyo Women's Medical University Medical Center East Keiyu Hospital Kitasato University Kitasato Institute Hospital
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	慶應義塾大学病院（東京都）、東京女子医科大学東医療センター（東京都）、けいゆう病院（神奈川県）、北里大学北里研究所病院（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 07 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 08 Month 07 Day
Anticipated trial start date	2015 Year 08 Month 10 Day
Last follow-up date	2016 Year 06 Month 06 Day
Date of closure to data entry
Date trial data considered complete	2016 Year 06 Month 06 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 08 Month 07 Day
Last modified on	2017 Year 08 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021466