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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046645
Receipt No. 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 2022/01/13

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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
Email 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
Email info@tes-h.co.jp

Sponsor
Institute Anti-Aging Bank Co.,Ltd.
Institute
Department

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
Email 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
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 Preinitiation
Date of protocol fixation
2022 Year 01 Month 11 Day
Date of IRB
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 01 Month 13 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053186

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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