UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023630 |
|---|---|
| Receipt number | 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 11:35:55 |
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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)
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
ebitamo@yahoo.co.jp
Sponsor or person
Institute
Keio university school of medicine, Department of dermatology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027213
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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