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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045727
Receipt No. R000052202
Scientific Title A randomized, open-label, parallel-group study to evaluate the efficacy of dry chemical mopping in adults with mild to moderate atopic dermatitis.
Date of disclosure of the study information 2021/10/12
Last modified on 2021/10/12

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Basic information
Public title A randomized, open-label, parallel-group study to evaluate the efficacy of dry chemical mopping in adults with mild to moderate atopic dermatitis.
Acronym Cleaning Research
Scientific Title A randomized, open-label, parallel-group study to evaluate the efficacy of dry chemical mopping in adults with mild to moderate atopic dermatitis.
Scientific Title:Acronym Cleaning Research
Region
Japan

Condition
Condition Atopic dermatitis of mild to moderate severity
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine if the use of floor mops or vacuum cleaners for 24 weeks makes a difference in IgE, an indicator of atopic dermatitis-related problems.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Group differences in the change in IgE between the initial value and the 24th week of use.
Key secondary outcomes The initial values for View Allergy39 will be the values on the day of the measurement selected for the study. View Allergy39 (only 18 items related to inhalation), TARC, eosinophils, and visual examination score at the dermatologist interview.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Floor mop is used for 24 weeks
Interventions/Control_2 Vacuum cleaner is used for 24 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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Men and women who are between 20 and 80 years old at the time of obtaining consent.
2) Those who are in charge of cleaning their homes, have a habit of cleaning with an electric vacuum cleaner, and are able to clean their homes early every morning.
3) Those who are able to come to the examination according to the set schedule.
4) Patients with mild to moderate atopic dermatitis who have stable symptoms (no change in medication, regardless of whether or not the patient has been to the hospital (to prevent changes in skin characteristics)). Patients with chronic diseases such as internal medicine that require regular visits to the hospital and treatment with oral medication will be included in the selection criteria, and changes in medication will be possible, although reporting will be required.
5) Those who have received sufficient explanation and written consent of their own free will to participate in this clinical study.
Key exclusion criteria 1) Persons who are active during the night and sleep during the day
2) Persons who are judged by the principal investigator or sub-investigator to be inappropriate as research subjects.
Target sample size 42

Research contact person
Name of lead principal investigator
1st name Koji
Middle name
Last name Habe
Organization Mie University Medical School Hospital / Mie University, Graduate School of Medicine
Division name Dermatology
Zip code 514-8507
Address 2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL 059-232-1111
Email habe-k@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name Koji
Middle name
Last name Umeda
Organization KSK Laboratories,Inc.
Division name representative
Zip code 514-0027
Address t.c.p 4F,7-15 Daimon, Tsu, Mie 514-0027, Japan
TEL 059-253-8091
Homepage URL
Email info@ksk-lab.co.jp

Sponsor
Institute Mie University, Graduate School of Medicine
Institute
Department

Funding Source
Organization matsuzaka co.,ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research Ethics Review Committee, Department of Medicine, Mie University School of Medicine
Address 2-174 Edobashi, Tsu, Mie 514-8507, Japan
Tel 059-231-5261
Email s-kikaku2@mo.medic.mie-u.ac.jp

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 三重大学 総合研究棟2(三重県津市)

Other administrative information
Date of disclosure of the study information
2021 Year 10 Month 12 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 Preinitiation
Date of protocol fixation
2021 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2022 Year 02 Month 01 Day
Last follow-up date
2022 Year 12 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
2021 Year 10 Month 12 Day
Last modified on
2021 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052202

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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