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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

Value
https://center6.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