UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050596 |
|---|---|
| Receipt number | R000057628 |
| Scientific Title | Home use test of carbonated serum about skin stimuli |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/03/15 15:27:13 |
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Basic information
Public title
Stinging test and home use test of carbonated serum
Acronym
Stinging test and home use test of carbonated serum
Scientific Title
Home use test of carbonated serum about skin stimuli
Scientific Title:Acronym
Home use test of carbonated serum about skin stimuli
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy against skin stinging feelings by a preservative.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Skin feelings of stimuli.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Stinging test:
Apply aqueous solution A to one cheek, then aqueous solution B to the other cheek
HUT:
Apply Serum A twice a day to all faces> Apply Serum B to all faces twice a day> Apply Serum C to all faces twice a day> Apply Serum D to all faces twice a day> repeat your own skin care, and repeat this three times.
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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Female aged 20-59
2. Full-time employees working at Kao Corporation in Odawara.
Key exclusion criteria
1. Person who are pregnant, breastfeeding, or may become pregnant in the near future.
2. Person who have seen skin symptoms such as strong sunburn, wounds, and acne at the test site by visual observation by the person in charge of the research.
3. Person who are currently undergoing outpatient treatment for atopic dermatitis.
4. Person who currently have allergic symptoms (hay fever, allergic rhinitis, etc.).
5. Person who are currently undergoing facial skin treatment.
6. Person who have already participated in other exams or plan to participate in other exams during this exam period.
7. Person who are judged by the Principal Investigator to be unsuitable for participation in the study due to other violations of compliance obligations, etc.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Nishijima |
Organization
Kao Corporation
Division name
Safety Science Research Lab.
Zip code
250-0002
Address
5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, JAPAN
TEL
+81-465-34-8944
nishijima.takafumi@kao.com
Public contact
Name of contact person
| 1st name | Ryoki |
| Middle name | |
| Last name | Kunita |
Organization
Kao Corporation
Division name
Safety Science Research Lab.
Zip code
250-0002
Address
5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, JAPAN
TEL
+81-465-34-8944
Homepage URL
kunita.ryoki@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.com
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 | 04 | Month | 01 | 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
| 2023 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 03 | Month | 15 | Day |
Last modified on
| 2023 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057628
| Research Plan | |
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| 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 |
