UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044476 |
|---|---|
| Receipt number | R000050810 |
| Scientific Title | Examination of safety and usefulness of hypoallergenic non-woven mask using ultrafine fibers |
| Date of disclosure of the study information | 2021/07/31 |
| Last modified on | 2023/12/11 09:03:10 |
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Basic information
Public title
Clinicall Research of Sarafua-Mask
Acronym
Research of Sarafua-Mask
Scientific Title
Examination of safety and usefulness of hypoallergenic non-woven mask using ultrafine fibers
Scientific Title:Acronym
Examination of safety and usefulness of hypoallergenic non-woven mask
Region
| Japan |
Condition
Condition
Mask dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By examining the safety and effectiveness of hypoallergenic non-woven masks (trade name: Sarafua Mask) in healthy individuals, we investigated whether the use of hypoallergenic non-woven masks can prevent the onset of mask dermatitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary endpoint: Evaluation of skin symptoms (physician evaluation)
Evaluation time: Before the start of the test, 5 days later, 11 days later
Evaluation method: The degree of dryness is evaluated on a scale of (4) advanced, (3) moderate, (2) mild, (1) slight, and (0) none.
Key secondary outcomes
Secondary evaluation item: Questionnaire survey (subject evaluation)
Evaluation time: Before, 5 days, 11 days after the start of the test
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
Hypoallergenic non-woven mask Brand name: Sarafua mask (Manufacturer: Kinsei Seishi)
Regular product Non-woven mask Product name: Non-woven mask Normal size (Manufacturer: System Polymer Co., Ltd.)
The subjects were in the group wearing the "Sarafua mask" for 5 days, 2 days after that, and the group wearing the regular product mask for 5 days.
Interventions/Control_2
The group wearing the regular product mask for 5 days, and 2 days later, the group wearing the "Sarafua mask" for 5 days.
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Age 20 to 95
2) Written consent has been obtained from the individual to participate in this test.
Key exclusion criteria
1) Subjects who are judged to be difficult to evaluate by the investigator or the coordinating doctor (those with dementia, those with allergies, those who cannot wear a mask)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shigetoshi |
| Middle name | |
| Last name | Sano |
Organization
Kochi Medical school, Kochi University
Division name
Department of Dermatology
Zip code
7838505
Address
Kohasu, Oko-cho, Nankoku, Kochi, Japan
TEL
0888802363
sano.derma@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Nakajima |
Organization
Kochi Medical school, Kochi University
Division name
Department of Dermatology
Zip code
7838505
Address
Kohasu, Oko-cho, Nankoku, Kochi, Japan
TEL
0888802363
Homepage URL
nakajima@kochi-u.ac.jp
Sponsor or person
Institute
Department of Dermatology, Kochi Medical school, Kochi University
Institute
Department
Personal name
Funding Source
Organization
KINSEI SEISHI 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
Department of Dermatology, Kochi Medical school, Kochi University
Address
Kohasu, Oko-cho, Nankoku, Kochi, Japan
Tel
0888802363
nakajima@kochi-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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 31 | 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
| 2021 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | 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 | 06 | Month | 08 | Day |
Last modified on
| 2023 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050810
