UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049405 |
|---|---|
| Receipt number | R000056164 |
| Scientific Title | Evaluation of moisturizing properties of "YW Moisturizing Gel" and "YF Moisturizing Gel |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2023/11/02 10:43:26 |
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Basic information
Public title
Evaluation of moisturizing properties of "YW Moisturizing Gel" and "YF Moisturizing Gel
Acronym
Evaluation of moisturizing properties of test product
Scientific Title
Evaluation of moisturizing properties of "YW Moisturizing Gel" and "YF Moisturizing Gel
Scientific Title:Acronym
Evaluation of moisturizing properties of test product
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the moisturizing properties of the test product by measuring skin moisture content and transepidermal water loss(portable moisture transpiration meter).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin water content and transdermal water loss before application, 0.5, 1,2,3,4,5 and 6 hours after application.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
YW Moisturizing Gel
Interventions/Control_2
YF Moisturizing Gel
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
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Japanese women between 20 and 60 years of age at the time of consent
2. Subjects who are self-conscious of dry skin and have dry skin on the inner side of the right and left forearms.
Key exclusion criteria
1. Subjects who are pregnant or may become pregnant, and those who are breast-feeding.
2. Subjects who are taking or applying any medication (e.g., moisturizers) that may affect the results of the study.
3. Subjects who routinely apply health supplements (e.g., supplements claiming moisturizing effects) that may affect the results of the study.
4. Subjects who may exhibit skin allergy symptoms or skin hypersensitivity.
5. Subjects who may show allergic symptoms to any of the test product ingredients.
6. Subjects with skin conditions that may affect the evaluation, such as scars, pimples, warts, burns, art makeup, etc. around the inner forearms on the right and left sides.
7. Subjects who are currently under the care of a dermatologist.
8. Subjects who are participating in other clinical trials.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Ito |
Organization
Vitamin C60 BioResearch Corporation
Division name
R&D Dept.
Zip code
103-0027
Address
Nihonbashi-Dori Nichome Bldg.4F 2-2-6 Nihon bashi Chuo-ku, Tokyo
TEL
03-3517-3253
masayuki.ito@vc60.com
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Ito |
Organization
Vitamin C60 BioResearch Corporation
Division name
R&D Dept.
Zip code
103-0027
Address
Nihonbashi-Dori Nichome Bldg.4F 2-2-6 Nihon bashi Chuo-ku, Tokyo
TEL
03-3517-3253
Homepage URL
masayuki.ito@vc60.com
Sponsor or person
Institute
SOUKEN
Institute
Department
Personal name
Funding Source
Organization
Vitamin C60 BioResearch 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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho Minato-ku, Tokyo
Tel
03-5408-1599
shiba_palace@s-palace-clinic.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 | 03 | 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 | 09 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 02 | Day |
Last modified on
| 2023 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056164
