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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009864
Receipt No. R000011487
Scientific Title Randomized controlled trial to evaluate the clinical efficacy of once- or twice-daily showering for prevention of atopic eczema exacerbation.
Date of disclosure of the study information 2013/01/28
Last modified on 2015/07/24

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Basic information
Public title Randomized controlled trial to evaluate the clinical efficacy of once- or twice-daily showering for prevention of atopic eczema exacerbation.
Acronym Evaluation of once- or twice-daily showering on atopic eczema.
Scientific Title Randomized controlled trial to evaluate the clinical efficacy of once- or twice-daily showering for prevention of atopic eczema exacerbation.
Scientific Title:Acronym Evaluation of once- or twice-daily showering on atopic eczema.
Region
Japan

Condition
Condition Atopic eczema
Classification by specialty
Clinical immunology Pediatrics Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the difference of clinical efficacy between once- and twice-daily showering for prevention of exacerbation in childhood atopic eczema.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. The rate of patients without exacerbation.
2. Number of days until the first exacerbation.
Key secondary outcomes 1. Number of weeks with additional application of topical corticosteroid.
2. Caregiver's QOL.
3. Scoring atopic dermatitis. (SCORAD)
4. Patient oriented eczema measure. (POEM)
5. Pruritus and sleeplessness score.
6. Incidence of skin infection.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Once-daily showering
Interventions/Control_2 Twice-daily showering
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
1 years-old <=
Age-upper limit
12 years-old >=
Gender Male and Female
Key inclusion criteria 1) Atopic eczema diagnosed with Hanifin & Rajka criteria.
2) Moderate or severe atopic eczema in the recent two years.
3) Applying topical corticosteroid every three or four days to keep good skin condition.
4) Mild eczema or cleared at registration.
5) Showering twice-daily.
6) Pruritus score is two points out of ten or less.
Key exclusion criteria Taking oral corticosteroids and/or oral immunosuppressive agents.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukihiro Ohya
Organization National Center for Child Health and Development
Division name Division of Allergy
Zip code
Address 2-10-1, Okura, Setagaya-ku, Tokyo
TEL 03-3416-0181
Email ohya-y@ncchd.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukihiro Ohya
Organization National Center for Child Health and Development
Division name Division of Allergy
Zip code
Address 2-10-1, Okura, Setagaya-ku, Tokyo
TEL 03-3416-0181
Homepage URL
Email ohya-y@ncchd.go.jp

Sponsor
Institute National Center for Child Health and Development
Institute
Department

Funding Source
Organization National Center for Child Health and Development
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 独)国立成育医療研究センター(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 28 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
2012 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 28 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 05 Month 31 Day
Date trial data considered complete
2015 Year 07 Month 31 Day
Date analysis concluded
2015 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 01 Month 24 Day
Last modified on
2015 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011487

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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