UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of soap for maintaining remission of eczema in children with atopic dermatitis - Investigator-Blinded, Randomized, Controlled Trial
Title of the study (Brief title)	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	Natsume Osamu
Organization	Hamamatsu University School of Medicine
Division name	department of pediatrics
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	Natsume Osamu
Organization	Hamamatsu University School of Medicine
Division name	department of pediatrics
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000033692