UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006876 |
|---|---|
| Receipt number | R000007547 |
| Scientific Title | A prospective study to evaluate the efficacy of proactive management in infantile atopic dermatitis for prevention of sensitization to house dust mite and atopic march |
| Date of disclosure of the study information | 2012/01/01 |
| Last modified on | 2013/12/20 22:56:13 |
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Basic information
Public title
A prospective study to evaluate the efficacy of proactive management in infantile atopic dermatitis for prevention of sensitization to house dust mite and atopic march
Acronym
A prospective study to evaluate the efficacy of proactive management for prevention of atopic march
Scientific Title
A prospective study to evaluate the efficacy of proactive management in infantile atopic dermatitis for prevention of sensitization to house dust mite and atopic march
Scientific Title:Acronym
A prospective study to evaluate the efficacy of proactive management for prevention of atopic march
Region
| Japan |
Condition
Condition
atopic dermatitis
Classification by specialty
| Clinical immunology | Pediatrics | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of proactive management in infantile atopic dermatitis for prevention of sensitization to house dust mite and Japanese cedar pollen
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
House dust mite specific IgE and house dust mite specific lymphocyte stimulation test [Time Frame: 24 months]
Key secondary outcomes
Japanese cedar pollen specific IgE and specific lymphocyte stimulation test [Time Frame: 24 months]
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-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
| Behavior,custom |
Interventions/Control_1
A proactive approach by using topical corticosteroids (i.e. twice-a-week) to all previously identified affected areas with confirmation of no exacerbation.
At exacerbation, patients apply topical corticosteroids everyday and subsequently return proactive application to any new skin areas where AD lesions have appeared.
Interventions/Control_2
A conventional treatment with emollient and daily skin care, using topical corticosteroids when flare.
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
| 0 | years-old | <= |
Age-upper limit
| 2 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Eligible patients are boys and girls aged 3 to 24 months with a diagnosis of atopic dermatitis or infantile eczema.
Key exclusion criteria
The exclusion criteria is as followed; (1) The patients receiving any additional systemic therapies included corticosteroids, nonsteroidal immunosuppressive agents or biological immunotherapy, (2) the patients who has a past history of cardiovascular disease, liver dysfunction, kidney disease and other current serious medical problems.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuki Fukuie |
Organization
Hamamatsu University School of Medicine
Division name
Department of Pediatrics
Zip code
Address
Handayama 1-20-1, Higashiku, Hamamatsushi,Shizuokaken, JAPAN
TEL
053-435-2312
fukuie-t@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuki Fukuie |
Organization
Hamamatsu University School of Medicine
Division name
Department of Pediatrics
Zip code
Address
Handayama 1-20-1, Higashiku, Hamamatsushi,Shizuokaken, JAPAN
TEL
053-435-2312
Homepage URL
http://square.umin.ac.jp/hamaped/
fukuie-t@hama-med.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS), Grant-in-Aid for Young Scientists B (No.23791165)
Organization
Division
Category of Funding Organization
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
浜松医科大学附属病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | 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
| 2011 | Year | 12 | Month | 12 | Day |
Last modified on
| 2013 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007547
| 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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