UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050142 |
|---|---|
| Receipt number | R000057108 |
| Scientific Title | Skin barrier function recovery confirmation test |
| Date of disclosure of the study information | 2023/05/31 |
| Last modified on | 2023/07/28 14:20:47 |
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Basic information
Public title
Long-term continuous use testing
Acronym
Skin barrier function recovery confirmation test
Scientific Title
Skin barrier function recovery confirmation test
Scientific Title:Acronym
Skin barrier function recovery test
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of 12 weeks of continuous use of Test Product 1 or Test Product 2 on skin stratum corneum water content, TEWL, replicated wrinkle area ratio at the corner of the eyes, average depth of total wrinkles, average depth of maximum wrinkles, and maximum depth of wrinkles in adult women with dry skin and wrinkles at the corner of eyes by comparing the same subjects at the start of application of Test Product 1 or Test Product 2 (0 weeks) and after 4, 8 and 12 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The effects on skin stratum corneum water content, TEWL, wrinkle area ratio at the corner of the eyes by replica collection, mean total wrinkle depth, mean maximum wrinkle depth, and maximum wrinkle depth will be examined by comparing the same subjects at the start of test product 1 or test product 2 application (0 weeks) with 4, 8 and 12 weeks later.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 36 | years-old | <= |
Age-upper limit
| 58 | years-old | >= |
Gender
Female
Key inclusion criteria
Recruit 40 candidates, measure stratum corneum water content and TEWL, and select 20 subjects with the lowest stratum corneum water content/TEWL values.
Key exclusion criteria
Persons who are deemed by the investigator (or the study investigator) to be unsuitable to participate in the study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hisae |
| Middle name | |
| Last name | Aoshima |
Organization
Vitamin C60 BioResearch Corporation
Division name
Department of Research and Development
Zip code
103-0027
Address
Nihonbashidori2chome Bldg. 4F 2-2-6 Nihonbashi, Chuo-ku, Tokyo, Japan
TEL
+81-3-3517-3253
hisae.aoshima@vc60.com
Public contact
Name of contact person
| 1st name | Hisae |
| Middle name | |
| Last name | Aoshima |
Organization
Vitamin C60 BioResearch Corporation
Division name
Department of Research and Development
Zip code
103-0027
Address
Nihonbashidori2chome Bldg. 4F 2-2-6 Nihonbashi, Chuo-ku, Tokyo, Japan
TEL
+81-3-3517-3253
Homepage URL
hisae.aoshima@vc60.com
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
self-financing
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
Brain Care Clinic Ethics Review Committee
Address
Hakutyo Build. 2F,2-1-2 Shinjuku,Shinjuku-ku, Tokyo, Japan
Tel
+81-3-6273-2214
ethics_board@drc-web.co.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
DRC株式会社
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | 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
| 2022 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 27 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 27 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 01 | Month | 26 | Day |
Last modified on
| 2023 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057108
