UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050146 |
|---|---|
| Receipt number | R000057107 |
| Scientific Title | Verification of skin moisturizing by combination of shower containing ultrafine bubbles and microbubble bathing |
| Date of disclosure of the study information | 2023/01/31 |
| Last modified on | 2023/01/25 11:22:41 |
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Basic information
Public title
Verification of skin moisturizing by combination of shower containing ultrafine bubbles and microbubble bathing
Acronym
Verification of skin moisturizing by combination of shower containing ultrafine bubbles and microbubble bathing
Scientific Title
Verification of skin moisturizing by combination of shower containing ultrafine bubbles and microbubble bathing
Scientific Title:Acronym
Verification of skin moisturizing by combination of shower containing ultrafine bubbles and microbubble bathing
Region
| Japan |
Condition
Condition
Dry skin
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluated the effects of ultrafine bubble (UFB) shower + micro bubble (MB) bathing and tap water shower + MB bathing on skin moisturizing, etc., using ultrafine bubble generator and micro bubble bath unit.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
stratum corneum water content
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Shower containing Ultra Fine Bubble + micro bubble hot water arm bathing
Interventions/Control_2
Tap water shower + micro bubble hot water arm bathing
Interventions/Control_3
Tap water shower + tap hot water arm bathing
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
| 30 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Subjects who have received sfficient explanation about the purpose and contents of this test, have the ability to consent, voluntarily apply for participation after understanding it well, and can consent to participate in this test in writing.
Key exclusion criteria
Serious illness, skin disease on the forearm, special skin care, sunburn beyond daily life with in 4 weeks, doctor judged inappropriate.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Furukawa |
Organization
Rinnai Corporation
Division name
R&D Headquarters
Zip code
480-0133
Address
3-1 Kaechi, Oguchi-cho,Niwa-gun, Aichi, Japan
TEL
0587-95-1902
rsiken200214@gmail.com
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Furukawa |
Organization
Rinnai Corporation
Division name
R&D Headquarters
Zip code
480-0133
Address
3-1 Kaechi, Oguchi-cho,Niwa-gun, Aichi, Japan
TEL
0587-95-1902
Homepage URL
rsiken200214@gmail.com
Sponsor or person
Institute
Rinnai Corporation
Institute
Department
Personal name
Funding Source
Organization
Rinnai Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo City University/Japan Health & Research Institute
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Health & Research Institute
Address
Garou Building 8F 3-1-4 Nihonbashi Cyuou-ku, Tokyo
Tel
03-5290-1621
info@jph-ri.or.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
| 2023 | Year | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 01 | Month | 26 | Day |
Last modified on
| 2023 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057107
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
