UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053319 |
|---|---|
| Receipt number | R000060861 |
| Scientific Title | Preliminary efficacy test of the moisturizer K-004(code) |
| Date of disclosure of the study information | 2024/01/15 |
| Last modified on | 2024/01/11 09:53:47 |
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Basic information
Public title
Efficacy test of the moisturizer
Acronym
Efficacy test of the moisturizer
Scientific Title
Preliminary efficacy test of the moisturizer K-004(code)
Scientific Title:Acronym
Efficacy test of the moisturizer
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 relationship between autonomic nervous system function, skin condition, and skin blood flow.
Basic objectives2
Others
Basic objectives -Others
To evaluate the relationship between autonomic nervous system function, skin condition, and skin blood flow in adult women.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between resting parasympathetic nerve activity and skin blood flow responsiveness to cold stress
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Adult female aged 20-35
2. Person whose body mass indexes are between 18.5 and 25.0.
3. Person whose DBP is greater 90 mmHg and SBP is less than 140 mmHg.
4. Person who has a stable menstrual cycle between 28-32 days.
Key exclusion criteria
1. Person who has allergic symptoms such as hay fever, rhinitis, atopic dermatitis, etc.
2. Person who has a vascular function disorder.
3. Person who currently smokes.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akane |
| Middle name | |
| Last name | Suma |
Organization
Kao Corporation
Division name
Skin Care Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-9581
suma.akane@kao.com
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd
Division name
Administrative Department of Clinical Trials.
Zip code
113-0033
Address
6F Kairaku Building, 2-7-5, Higashiueno, Taito-ku, Tokyo, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd
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
うえの あさがおクリニック(東京都)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 15 | 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 | 12 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analysis of the relationship between autonomic nervous system function, skin condition, and skin blood flow.
Management information
Registered date
| 2024 | Year | 01 | Month | 11 | Day |
Last modified on
| 2024 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060861
