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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036805
Receipt No. 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

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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
Email 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
Email yuttttti.k@gmail.com

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041926

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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