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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029489
Receipt No. R000033692
Scientific Title Effectiveness of soap for maintaining remission of eczema in children with atopic dermatitis - Investigator-Blinded, Randomized, Controlled Trial
Date of disclosure of the study information 2017/10/20
Last modified on 2018/10/25

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Basic information
Public title Effectiveness of soap for maintaining remission of eczema in children with atopic dermatitis - Investigator-Blinded, Randomized, Controlled Trial
Acronym Usefulness of Soap to Atopic dermatitis (USA) study
Scientific Title Effectiveness of soap for maintaining remission of eczema in children with atopic dermatitis - Investigator-Blinded, Randomized, Controlled Trial
Scientific Title:Acronym Usefulness of Soap to Atopic dermatitis (USA) study
Region
Japan

Condition
Condition atopic dermatitis
Classification by specialty
Pediatrics Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the effectiveness of wash with soap for treating eczema in children with atopic dermatitis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes The difference of absolute change in EASI score from baseline to week 8 between the soap side and the non-soap side.
Key secondary outcomes The difference 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 times of additional application of steroid ointment during intervention between the soap side and the non-soap side.
Evaluation of usefulness of soap by participants(3 stages 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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
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 with soap for 5 to 11 weeks.
Interventions/Control_2 Participants wash their upper and lower limbs on the other side without soap for 5 to 11 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
0 years-old <=
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 is 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 bathing less than 5 days within the recent one week before registration.
Patients with skin infection.
Patients whom the doctor assesses ineligible.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Natsume Osamu
Organization Hamamatsu University School of Medicine
Division name department of pediatrics
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3192, Japan
TEL 053-435-2111
Email natsumeo@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Natsume Osamu
Organization Hamamatsu University School of Medicine
Division name department of pediatrics
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3192, Japan
TEL 053-435-2111
Homepage URL
Email natsumeo@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine, department of pediatrics
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Morimachi Hospital
Chutoen General Medical Center
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
2017 Year 10 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 Completed
Date of protocol fixation
2017 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
2018 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
2018 Year 09 Month 30 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 10 Day
Last modified on
2018 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033692

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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