UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038829 |
|---|---|
| Receipt number | 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 09:27:36 |
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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
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
hiroko.yatsuhashi@glico.com
Sponsor or person
Institute
Glico Nutrition Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044062
