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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023630
Receipt No. R000027213
Scientific Title Safety and Efficacy of Bleach bath therapy as a treatment for atopic dermatitis
Date of disclosure of the study information 2016/08/31
Last modified on 2018/10/29

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Basic information
Public title Safety and Efficacy of Bleach bath therapy as a treatment for atopic dermatitis
Acronym Safety and Efficacy of Bleach bath therapy for AD
Scientific Title Safety and Efficacy of Bleach bath therapy as a treatment for atopic dermatitis
Scientific Title:Acronym 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
1st name
Middle name
Last name Tamotsu Ebihara
Organization Keio university school of medicine
Division name Department of dermatology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211(62413)
Email ebitamo@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tamotsu Ebihara
Organization Keio university school of medicine
Division name Department of dermatology
Zip code
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)

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 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

Related information
URL releasing protocol
Publication of results Unpublished

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 No longer recruiting
Date of protocol fixation
2016 Year 07 Month 05 Day
Date of IRB
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

Other
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

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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