UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046645 |
|---|---|
| Receipt number | R000053186 |
| Scientific Title | Study of the effect of improving wrinkles at the corners of the eyes by using skin care cosmetics |
| Date of disclosure of the study information | 2022/01/15 |
| Last modified on | 2022/07/08 15:05:31 |
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Basic information
Public title
Study of the effect of improving wrinkles at the corners of the eyes by using Asakado skin care cosmetics
Acronym
Study of the effect of improving wrinkles at the corners of the eyes by using Asakado skin care cosmetics
Scientific Title
Study of the effect of improving wrinkles at the corners of the eyes by using skin care cosmetics
Scientific Title:Acronym
Study of the effect of improving wrinkles at the corners of the eyes by using skin care cosmetics
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of skin care cosmetics on improving wrinkles at the corners of the eyes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
evaluation of wrinkles(JCSS)
Key secondary outcomes
Skin elasticity evaluation, evaluation by questionnaire
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
apply test cosmetics
Interventions/Control_2
Do not apply test cosmetics
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
| 35 | years-old | <= |
Age-upper limit
| 55 | years-old | > |
Gender
Female
Key inclusion criteria
[1]Japanese females aged 35-54 years
[2]Individuals who do not have chronic physical illnesses, including skin disorders
[3]Individuals whose wrinkles at the corners of the eyes are judged to be wrinkle great 1-3
[4]Individuals who have wrinkles at the corners of the eyes that are almost symmetrical
[5]Individuals whose written informed consent has been obtained
[6]Individuals who can come to the designated examination date and receive the examination
[7]Individuals judged appropriate for the study by the principal
Key exclusion criteria
Individuals (who)
[1]using medical products
[2]under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders
[3]with history of serious diseases (hepatic, renal, cardiovascular, respiratory, hematologic, etc.)
[4]have a history and/or contract digestive disease
[5]with a history of cosmetic troubles or current medical history
[6]with skin symptoms such as atopic dermatitis, perioral dermatitis, and rosacea-like dermatitis
[7]with experience in cosmetology and aesthetic medicine that affect the measuring area
[8]have performed or received the following acts within the past 3 months
a.Hormone replacement therapy
b.Use of cosmetics (eye cream, sealer, patch, etc.) that have strong moisturizing effect and wrinkle-related effect
c.Regular use of medicines, quasi-drugs, foods and drinks for the purpose of improving the skin
[9]have an inflammation or a scar on a measuring area
[10]receiving/received medical drug treatment for the past 1 month except for temporary relief medication for headache, menstrual pain, common cold, etc.
[11]drink more than 60g/day on average in terms of pure alcohol
[12]with possible changes of life style during test periods
[13]will develop seasonal allergy symptoms, such as pollinosis, use an anti-allergic drug
[14]can't avoid direct sunlight exposure, such as sunburn, during test periods.
[15]are or are possibly pregnant, or are breastfeeding
[16]are participating and/or had participated in other clinical studies within the last 3 months
[17]are judged as not appropriate to this study by a responsible doctor
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Yonei |
Organization
Faculty of Life and Medical Sciences,Doshisha University
Division name
Anti-Aging Medical Research Center
Zip code
6100394
Address
1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL
0774-65-6394
yyonei@mail.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Tamura |
Organization
TES Holdings Co., Ltd.
Division name
Department of Clinical Trial
Zip code
1100015
Address
6F,Kairaku Bldg,2-7-5 Higashi-Ueno,Taitou-ku,Tokyo
TEL
03-6801-8400
Homepage URL
info@tes-h.co.jp
Sponsor or person
Institute
Anti-Aging Bank Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
NABOCULcosmetics.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
Society of Glycative Stress Research
Address
5F-11,Musashino Bldg,2-13-10 Shinjuku,Shinjuku-ku,Tokyo
Tel
03-6709-8842
rinri-glycativestress@antiaging-bank.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
| 2022 | 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
34
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 | 01 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | 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 | 01 | Month | 14 | Day |
Last modified on
| 2022 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053186
