UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036805 |
|---|---|
| Receipt number | R000041926 |
| Scientific Title | Effectiveness of soap for maintaining remission of eczema in children with atopic dermatitis-asssessor blinded,randomized,Controlled trial |
| Date of disclosure of the study information | 2019/05/20 |
| Last modified on | 2019/07/14 22:15:08 |
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Basic information
Public title
Effectiveness of soap for maintaining remission of eczema in children with atopic dermatitis-asssessor blinded,randomized,Controlled trial
Acronym
Usefullness of soap to atopic dermatitis study
Scientific Title
Effectiveness of soap for maintaining remission of eczema in children with atopic dermatitis-asssessor blinded,randomized,Controlled trial
Scientific Title:Acronym
Usefullness of soap to atopic dermatitis study
Region
| Japan |
Condition
Condition
atopic dermatitis
Classification by specialty
| Pediatrics | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate that no use of soap is not inferior to using soap in children with atopic dermatitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference of EASI score at week 8 between the soap side and the non-soap side.
Key secondary outcomes
The differnce of the mean value of POEM score during intervention between the soap side and the non-soap side.
The difference of the total number of additional application of steroid ointment during intervention between the soap side and the non-soap side.
The difference of hydration in the stratum corneum at week 8 between the soap side and the non-soap side.
Evaluation of usefullness of soap by participant(5 stage Likert scale).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants wash their upper and lower limbs on one side without soap for 4 to 12 weeks.
Interventions/Control_2
Participants wash their upper and lower limbs on the other side with soap for 4 to 12 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
| Not applicable |
Age-upper limit
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Children who were diagnosed with atopic dermatitis based on the U.K.Working Party's diagnostic criteria.
Patients under 15 years old.
Patients whose eczema is controlled on regular application of steroid ointment within 2 days per week(Use of tacrolimus ointment in permitted).
Patients who take a bath or shower at least once a day.
Patients who agreed to participate in this study in writing.
Key exclusion criteria
Patients with obvious left-right difference of eczema before starting intervention.
Patients with skin infection.
Patients whom the doctor assessed ineligible.
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Natsume |
Organization
Hamamatsu University School of Medicine
Division name
Pediatrics
Zip code
431-3192
Address
1-20-1 Handayama, Higashiku, Hamamatsu City, Shizuoka Prefecture
TEL
053-435-2111
natsumeo@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Katoh |
Organization
Hamamatsu University School of Medicine
Division name
Pediatrics
Zip code
431-3192
Address
1-20-1 Handayama, Higashiku, Hamamatsu City, Shizuoka Prefecture
TEL
053-435-2111
Homepage URL
yuttttti.k@gmail.com
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashiku, Hamamatsu City, Shizuoka Prefecture
Tel
053-435-2111
yuttttti.k@gmail.com
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（静岡県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 20 | 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
| 2019 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 20 | Day |
Last modified on
| 2019 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041926
