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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038829
Receipt No. R000044062
Scientific Title Anti-wrinkle function test in use of product "4625-HK202MM-G"
Date of disclosure of the study information 2019/12/10
Last modified on 2020/06/09

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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/ctr_e/ctr_view.cgi?recptno=R000044062

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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