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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013442
Receipt No. R000015546
Scientific Title Analysis of the efficacy of Bleach bath therapy in patients with atopic dermatitis
Date of disclosure of the study information 2014/04/01
Last modified on 2015/10/28

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Basic information
Public title Analysis of the efficacy of Bleach bath therapy in patients with atopic dermatitis
Acronym Analysis of the efficacy of Bleach bath therapy in patients with atopic dermatitis
Scientific Title Analysis of the efficacy of Bleach bath therapy in patients with atopic dermatitis
Scientific Title:Acronym Analysis of the efficacy of Bleach bath therapy in patients with atopic dermatitis
Region
Japan

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

Objectives
Narrative objectives1 To analyze efficacy and safety of a Bleach bath therapy (0.005% sodium hypochlorite baths) in patients with atopic dermatitis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Transition of SCPRAD, blood test, bacterial culture and microbiota.
Key secondary outcomes Adverse event

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 Bathing to a 0.005% sodium hypochlorite content bath 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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients with moderate to severe atopic dermatitis (SCORAD 20 or more)
Key exclusion criteria 1.A patient under pregnancy and breast-feeding , and withes to become pregnant during this study.
2.A patient who is on systemic therapy to atopic dermatitis such as oral orticosteroid, immunosuppressant and phototherapy.(before registration 2 weeks or more)
3.a patient with coexisting disease which needs the treatment of oral corticosteroid and/or immunosuppressant.
4. A patient with sensitivity to sodium hypochlorite.
5. A ptiemt with the past history of malignant tumor.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatotsu Ebihara
Organization Keio Univercity School of Medicine
Division name Department of Dermatology
Zip code
Address 35 Shiannomachi Shinjuku-ku
TEL 03-3353-1211
Email ebitamo@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tamotsu Ebihara
Organization Keio Univercity School of Medicine
Division name Department of Dermatology
Zip code
Address 35 Shiannomachi Shinjuku-ku
TEL 03-3353-1211
Homepage URL
Email ebitamo@yahoo.co.jp

Sponsor
Institute Department of Dermatology,Keio Univercity School of Medicine
Institute
Department

Funding Source
Organization Department of Dermatology,Keio Univercity School of Medicine
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 01 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 Completed
Date of protocol fixation
2014 Year 03 Month 05 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 24 Day
Last follow-up date
2015 Year 10 Month 31 Day
Date of closure to data entry
2015 Year 10 Month 31 Day
Date trial data considered complete
2015 Year 12 Month 31 Day
Date analysis concluded
2016 Year 10 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 03 Month 17 Day
Last modified on
2015 Year 10 Month 28 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015546

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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