UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044604 |
|---|---|
| Receipt number | R000049280 |
| Scientific Title | Questionnaire survey on the usability of bicarbonate bath salts for dermatologists |
| Date of disclosure of the study information | 2021/06/21 |
| Last modified on | 2024/04/01 13:39:15 |
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Basic information
Public title
Questionnaire survey on the usability of bicarbonate bath salts for dermatologists
Acronym
Questionnaire survey on the usability of bicarbonate bath salts for dermatologists
Scientific Title
Questionnaire survey on the usability of bicarbonate bath salts for dermatologists
Scientific Title:Acronym
Survey on the usability of bicarbonate bath salts
Region
| Japan |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This questionnaire survey is an exploratory survey that serves as a reference for study design for creating evidence for bicarbonate bath salts.
Basic objectives2
Others
Basic objectives -Others
Usability evaluation
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensation after using the evaluation object product for 4 consecutive weeks
Key secondary outcomes
Attributes of survey collaborators
Daily bathing habits / usage of bath salts
Thoughts on bath salts
Recommendation level for bicarbonate bath salts
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
･Female doctors providing dermatological treatments and consent to participate in this questionnaire survey.
･Subjects who take a bath every day or almost every day
Key exclusion criteria
None
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Kawashima |
Organization
Non-Profit Organization Health Institute Research of Skin
Division name
Vice Chairman/Principal Investigator
Zip code
1010047
Address
Fukuda Building 2F, Uchikanda1-8-9 , Chiyoda-ku, Tokyo
TEL
03-3256-2575
info@npo-hifu.net
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Miyahara |
Organization
EBC&M LCC.
Division name
Investigation Secretariat
Zip code
105-0011
Address
Shiba Matsuo Building 4F, 2-9-1 Shibakoen, Minato-ku, Tokyo
TEL
03-6435-3833
Homepage URL
noriko_miyahara@ebc-m.com
Sponsor or person
Institute
Investigation Secretariat, EBC&M LCC.
Institute
Department
Personal name
Funding Source
Organization
wakarimasenn
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
Non-Profit Organization Health Institute Research of Skin Ethics Review Board
Address
Fukuda Building 2F, Uchikanda1-8-9 , Chiyoda-ku, Tokyo
Tel
03-3256-2575
info@npo-hifu.net
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 | 06 | Month | 21 | 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
50
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 | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 21 | Day |
Date of closure to data entry
| 2021 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 02 | Day |
Date analysis concluded
| 2021 | Year | 07 | Month | 06 | Day |
Other
Other related information
Usability survey by questionnaire
Management information
Registered date
| 2021 | Year | 06 | Month | 21 | Day |
Last modified on
| 2024 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049280
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
