UMIN-CTR Clinical Trial

Basic information
Public title	Anti-wrinkle function test in use of product "4625-HK202MM-G"
Acronym	Efficacy test in use of product "4625-HK202MM-G"
Scientific Title	Anti-wrinkle function test in use of product "4625-HK202MM-G"
Scientific Title:Acronym	Efficacy test in use of product "4625-HK202MM-G"
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the effect of improvement on skin wrinkles using cream "4625-HK202MM-G"
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Wrinkle assessment of eye corner, Wrinkle evaluation using the replica of eye corner
Key secondary outcomes	Questionnaire, Skin condition, Wrinkle assessment, Wrinkle evaluation using the replica of eye corner

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
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	The test product "4625-HK202MM-G" is applied twice a day for 9 weeks to the eye corners of the half-faces randomly assigned by the person in charge of assignment.
Interventions/Control_2	The pracebo product "4625-HK202MM-P" is applied twice a day for 9 weeks to the eye corners of the half-faces randomly assigned by the person in charge of assignment.
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	30 years-old <=
Age-upper limit	55 years-old >=
Gender	Female
Key inclusion criteria	Those who have main wrinkles (wrinkle grade: from 3 to 5) in the both eye corners
Key exclusion criteria	1.Wrinkle grade scores on the left and right eye corners in the pre-examination are significantly different (as a guide, there is a difference of +- 1.0 or more between left and right) 2.Persons who may act that tends to cause a difference in left and right wrinkles in the their daily lives (such as those who are mainly engaged in driving cars) 3.Those who have factors in the evaluation site of the skin that may affect the result of the test (diseases such as atopic dermatitis and urticaria, inflammation, eczema, trauma, acne, pimples, warts, etc., or traces entities) 4.Those who have undergone cosmetic treatment (botox injection, hyaluronic acid or collagen injection, photofacial treatment, etc.) that affects the evaluation site, or who are scheduled to receive during the test period 5.Those who have received or plan to receive special skin care (beauty salon, aesthetics, etc.) within 4 weeks or during the test period. 6.Those who use skin care products constantly, such as cosmetics, quasi-drugs, healthy foods, etc. that have the same or related effectiveness as the efficacy in this study (against whrinkles). 7.Those who have changed or have started to use cosmetics such as basic care or sunscreen agents, and healthy food within 4 weeks before the test. 8.Persons who have been exposed to ultraviolet rays beyond their daily lives, such as prolonged work outdoors, exercise, sea bathing, leisure, etc. within 4 weeks before the test period, or who are scheduled to do so during the test period 9.Persons working night shifts and day/night shifts 10.At the time of obtaining consent, a person who has received treatment (hormone replacement therapy, drug therapy, exercise therapy, diet, etc.) at a medical institution for the treatment or prevention of illness, or a condition that requires treatment Who is judged
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Sumio Middle name Last name Kondo
Organization	Medical Corpoation Kenshokai Fukushima Healthcare Center
Division name	Department of Internal Medicine, Neurosurgery
Zip code	553-0004
Address	2-12-16, Tamagawa Fukushima-ku, Osaka, Japan
TEL	81-(0)6-6882-1130
Email	s.kondo@drc-web.co.jp

Public contact
Name of contact person	1st name Hiroko Middle name Last name Yatsuhashi
Organization	Ezaki Glico Co., Ltd.
Division name	Institute of Health Sciences
Zip code	555-8502
Address	4-6-5, Utajima, Nishiyodogawa-ku, Osaka, Japan
TEL	+81-6-6477-8425
Homepage URL
Email	hiroko.yatsuhashi@glico.com

Sponsor
Institute	Glico Nutrition Co., Ltd.
Institute
Department

Funding Source
Organization	Glico Nutrition 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	Brain Care Clinic Ethics Review Committee
Address	Samon-Cho 13, Isobe Build. 2F, Shinjyuku-ku, Tokyo
Tel	81-(0)6-6882-1130
Email	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

Other administrative information
Date of disclosure of the study information	2019 Year 12 Month 10 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	2019 Year 11 Month 29 Day
Date of IRB	2019 Year 11 Month 29 Day
Anticipated trial start date	2019 Year 12 Month 14 Day
Last follow-up date	2020 Year 04 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 12 Month 09 Day
Last modified on	2020 Year 06 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044062