UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029489 |
|---|---|
| Receipt number | 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 05:21:39 |
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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
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
natsumeo@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine, department of pediatrics
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033692
