UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018583 |
|---|---|
| Receipt number | 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 15:28:26 |
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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)
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021466
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
