UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049260 |
|---|---|
| Receipt number | R000056047 |
| Scientific Title | Skin clarity evaluation test by using the test product for 8 weeks |
| Date of disclosure of the study information | 2023/05/02 |
| Last modified on | 2023/10/20 09:13:13 |
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Basic information
Public title
Skin clarity evaluation test by using the test product for 8 weeks
Acronym
Skin clarity enhancement test
Scientific Title
Skin clarity evaluation test by using the test product for 8 weeks
Scientific Title:Acronym
Skin clarity enhancement test
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The subjects will be healthy adult women who are concerned about dullness and lack of clarity in their skin on the whole face. The effect of using the test product for 8 weeks on the clarity of the skin will be examined by comparing before and after use of the test product by the same subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin clarity
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
test product
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
Those who are concerned about dullness and lack of transparency of the skin on a daily basis, and who take simple care of their skin with lotion and milky lotion only.
Key exclusion criteria
(1)Those with red faces
(2) Those who have either excessive rough skin, many fine freckle-like spots, or large, dark spots on the skin in the third position.
(3) Any skin conditions (urticaria, inflammation, eczema, trauma, acne, pimples, warts, etc., or traces of such conditions) that may affect the results of the study on the skin of the evaluation site.
(4) Patients with a history or current history of atopic dermatitis or with a predisposition to atopic dermatitis.
(5) Applicants who have undergone or will undergo cosmetic treatment (Botox injections, hyaluronic acid or collagen injections, photofacials, etc.) on the evaluation site during the examination period.
(6) Have undergone or are scheduled to undergo special skin care procedures (beauty salons, esthetic clinics, etc.) on the evaluation site within the past 4 weeks.
(7) The applicant uses quasi-drug lotions, milky lotions, creams, all-in-one products, serums, and packs as daily skin care products for the evaluation site.
(8) Those who use basic skin care products containing vitamin C or health foods containing vitamin C on a regular basis as daily skin care for the evaluated area.
(9) The subject continuously uses skincare products, cosmetics, quasi-drugs, or health food products that claim or emphasize efficacy (prevention and improvement of age spots, whitening effect) similar to or related to the efficacy studied in this study on the evaluated area.
(10) Exposure to ultraviolet radiation beyond daily activities such as prolonged outdoor work, exercise, swimming, leisure activities, etc., within the past 4 weeks or plans to do so during the study period (e.g., golf, fishing, etc.).
(11) Patients who are undergoing treatment (hormone replacement therapy, drug therapy, exercise therapy, diet therapy, etc.) at a medical institution for the treatment or prevention of disease, or whose condition is judged to be in need of treatment at the time of obtaining consent.
-and other
Target sample size
25
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 Nihonbashi 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 Nihonbashi Chuo-ku, Tokyo
TEL
03-3517-3253
Homepage URL
masayuki.ito@vc60.com
Sponsor or person
Institute
DRC CO., LTD.
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
Brain Care Clinic Ethics Review Committee.
Address
Hakutyo Build. 2F,2-1-2 Shinjuku,Shinjuku-ku,Tokyo
Tel
03-6273-2214
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 | 02 | 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 | 27 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2022 | Year | 10 | Month | 19 | Day |
Last modified on
| 2023 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056047
