UMIN-CTR Clinical Trial

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

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

Objectives
Narrative objectives1	to assess the safety and efficacy of bleach bath therapy for treatment of atopic dermatitis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	SCORAD on each visit
Key secondary outcomes	the volume of topical steroid or tacrolimus ointment adverse events blood test data

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	to take 0.005% dose of sodium hypochlorite baths for 5-10 minutes for three months,, twice a week
Interventions/Control_2
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	7 years-old <=
Age-upper limit	99 years-old >=
Gender	Male and Female
Key inclusion criteria	atopic dermatitis patients who are more than 7 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 except for carcinoma in situ patients who are unable to remain off topical or systemic oral antibiotics prior to body site sampling patients who has been already treated with bleach bath therapy prior to the study
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	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	東京女子医科大学東医療センター けいゆう病院 北里大学北里研究所病院

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 31 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 07 Month 05 Day
Anticipated trial start date	2016 Year 09 Month 05 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 08 Month 15 Day
Last modified on	2018 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027213