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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000018583
Receipt No. R000021466
Scientific Title Efficacy of Bleach bath therapy as a maintenance treatment of atopic dermatitis
Date of disclosure of the study information 2015/08/07
Last modified on 2017/08/11

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Basic information
Public title Efficacy of Bleach bath therapy as a maintenance treatment of atopic dermatitis
Acronym Bleach bath therapy for atopic dermatitis
Scientific Title Efficacy of Bleach bath therapy as a maintenance treatment of atopic dermatitis
Scientific Title:Acronym 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
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 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)

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 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

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 Terminated
Date of protocol fixation
2015 Year 08 Month 07 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000021466

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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