UMIN-CTR Clinical Trial

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