UMIN-CTR Clinical Trial

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