UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005158 |
|---|---|
| Receipt number | 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 09:10:18 |
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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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005803
