UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009864 |
|---|---|
| Receipt number | 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 13:01:03 |
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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
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
ohya-y@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011487
