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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005158
Receipt No. R000005803
Scientific Title Randomized controlled trial to evaluate clinical efficacy of once- or twice-daily skincare with emollient for prevention of atopic dermatitis exacerbation
Date of disclosure of the study information 2011/03/07
Last modified on 2011/05/02

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Basic information
Public title Randomized controlled trial to evaluate clinical efficacy of once- or twice-daily skincare with emollient for prevention of atopic dermatitis exacerbation
Acronym Randomized controlled trial of once- or twice-daily skincare for atopic dermatitis
Scientific Title Randomized controlled trial to evaluate clinical efficacy of once- or twice-daily skincare with emollient for prevention of atopic dermatitis exacerbation
Scientific Title:Acronym Randomized controlled trial of once- or twice-daily skincare for atopic dermatitis
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 difference of clinical effectiveness between once and twice daily skincare for prevention of exacerbation in childhood atopic dermatitis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. The rates of patients with free of recurrence during 28 days of intervention.
2. No symptom days after entry of this intervention.
Key secondary outcomes 1. QOL of a caregiver (a parent)
2. Scoring atopic dermatitis (SCORAD)
3. 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
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Once- daily skincare during 4 to 6 weeks
Interventions/Control_2 Twice-daily skincare During 4 to 6 weeks
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
15 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients who are diagnosed as having atopic dermatitis based on the diagnostic criteria of Hanifin & Rajka
2) Patients who were diagnosed as having moderate or severe atopic dermatitis within a year
3) Patients whose skin condition should be maintained without skin eczema by using twice weekly betamethasone valerate ointment and twice daily emollient at the time of enrollment
4) Patients who can adhere twice-daily skincare treatment.
Key exclusion criteria Patients who are taking oral steroids and/or oral immunosuppressive drug
Target sample size 150

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, Setagayaku, Tokyo
TEL 03-3416-0181
Email

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, Setagayaku, Tokyo
TEL 03-3416-0181
Homepage URL
Email

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

Other administrative information
Date of disclosure of the study information
2011 Year 03 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 Open public recruiting
Date of protocol fixation
2010 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2011 Year 03 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 03 Month 01 Day
Last modified on
2011 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005803

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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