UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045727 |
|---|---|
| Receipt number | 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 | 2024/10/02 12:40:38 |
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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
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
info@ksk-lab.co.jp
Sponsor or person
Institute
Mie University, Graduate School of Medicine
Institute
Department
Personal name
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
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 12 | Day |
Last modified on
| 2024 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052202
