UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045868 |
|---|---|
| Receipt number | R000051927 |
| Scientific Title | Effect of cosmetics containing material G on the improvement of skin texture |
| Date of disclosure of the study information | 2021/10/26 |
| Last modified on | 2022/04/26 15:23:53 |
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Basic information
Public title
Effect of cosmetics containing material G on the improvement of skin texture
Acronym
Effect of cosmetics containing material G on the improvement of skin texture
Scientific Title
Effect of cosmetics containing material G on the improvement of skin texture
Scientific Title:Acronym
Effect of cosmetics containing material G on the improvement of skin texture
Region
| Japan |
Condition
Condition
Healthy individual
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of effect of cosmetics containing material G
on the improvement of skin texture
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin evaluation indices (moisture content in the stratum corneum, water transpiration amount through the epidermis)
3 measurement time points: Week 0, Week 4, Week 8
Key secondary outcomes
Blemishes, wrinkles, pores, texture, porphyrin, luster, color, rough skin, skin
elasticity, collagen, stratum corneum cells, questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Lotion containing material G (with material G)
Apply the specimens separately to the left and right sides of the face.
Interventions/Control_2
Placebo control (without material G)
Apply the specimens separately to the left and right sides of the face.
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
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
(1)The age at the time of obtaining a consent is 20 years or older.
(2)Female
(3)Those from whom a written consent can be obtained on a voluntary basis.
Key exclusion criteria
Persons who have chronic skin conditions such as atopic dermatitis in the area
(face) where the test product is applied
Persons who have participated in other clinical trials (drugs) or health food trials and trials where drugs or other substances are applied within the past 3 months
Persons with a history of allergies to cosmetics
Persons using whitening or anti-wrinkle cosmetics
Persons who take beauty supplements and drinks on a daily basis.
Persons who have undergone chemical peeling, laser treatment, phototherapy, cosmetic surgery, etc. on their face within 4 weeks prior to the start of the clinical investigation, or those who plan to undergo such treatments during the investigation period.
Persons with underlying medical conditions or those undergoing treatment or medication for any disease
Patients taking hormone replacement treatment
Patients who are pregnant or may become pregnant, and those who are breastfeeding.
Persons for whom the study investigator deems unsuitable for participation in the investigation.
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | kenta |
| Middle name | |
| Last name | SHINGAKI |
Organization
Noevir Co.,Ltd.
Division name
Groupwide Reseach and Development
Zip code
213-0012
Address
R&D C Building No.333, Kanagawa Science Park(KSP),3-2-1 Sakado, Takatsu-ku, Kawasaki City, Kanagawa
TEL
044-813-2488
tokyolab@n1.noevir.co.jp
Public contact
Name of contact person
| 1st name | yousuke |
| Middle name | |
| Last name | SHINKAI |
Organization
Noevir Co.,Ltd.
Division name
Groupwide Reseach and Development
Zip code
213-0012
Address
R&D C Building No.333, Kanagawa Science Park(KSP),3-2-1 Sakado, Takatsu-ku, Kawasaki City, Kanagawa
TEL
044-813-2488
Homepage URL
tokyolab@n1.noevir.co.jp
Sponsor or person
Institute
Noevir Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Noevir Co.,Ltd.
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, 105-0013, JAPAN
Tel
03-5408-1590
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
| 2021 | Year | 10 | Month | 26 | 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
13
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
| 2021 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 26 | Day |
Last modified on
| 2022 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051927
