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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

Value
https://center6.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