UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041531
Receipt number R000047415
Scientific Title SO834 anti-wrinkle function evaluation test
Date of disclosure of the study information 2020/08/24
Last modified on 2021/01/12 10:30:11

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Basic information

Public title

SO834 anti-wrinkle function evaluation test

Acronym

SO834 anti-wrinkle function evaluation test

Scientific Title

SO834 anti-wrinkle function evaluation test

Scientific Title:Acronym

SO834 anti-wrinkle function evaluation test

Region

Japan


Condition

Condition

N/A (Japanese healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to confirm the safety of test cosmetics, and the efficacy of making fine wrinkles due to drying inconspicuous.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Depth and safety of wrinkles around the eyes
[1] Photo evaluation (wrinkle grade evaluation)
[2] Equipment evaluation (3D analysis method by replica)
[3] Doctor consultation (Safety assessment)

Key secondary outcomes

[1] Questionnaire (before pasting, after pasting)
[2] Life diary (every day during the test period)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) 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

Attaching the test product(Right eye corner:test cosmetic application,Left eye corner:No pasting)

Interventions/Control_2

Attaching the test product(Right eye corner:No pasting,Left eye corner:test cosmetic application)

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

59 years-old >=

Gender

Female

Key inclusion criteria

1.Those who have wrinkles mainly corresponding to Grade 1 to 3 on the outer corners of the eyes
2.Japanese healthy female aged 35 to 59 at the time of screening test
3.A person who has sufficiently explained about the test product and the purpose and contents of this test, and has obtained the written consent of the test subject to participate in the test voluntarily.

Key exclusion criteria

1.Those who have a clear bias in left and right wrinkle grade
2.Those who have factors that affect the evaluation site (disease such as atopic dermatitis, trauma, burns, inflammation, acne, warts, or those traces)
3.Those who are currently visiting the hospital for a disease that has an affected area on their face
4.Those who have a history of allergies to cosmetics
5.People receiving hormone replacement therapy
6.Those who are pregnant or breastfeeding, or who wish to become pregnant during the period from the time of obtaining consent to the end of the study
7.Those who have experience in aesthetic medicine that affects the evaluation site, or those who plan to receive it during the test period
8.A person who has undergone a special skin care treatment (facial treatment, etc.) that affects the evaluation site from 4 weeks before the application of the test product, or a person who plans to receive it during the test period.
9.Those who continue to use cosmetics, health foods, etc. that advocate or appeal the efficacy related to this test to the evaluation site
10.A person who has received the test product in another clinical trial within 4 weeks after the test product is applied, or a person who plans to participate during the test period
11.In addition, those who are judged to be ineligible by the investigator

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Kazuhiko
Middle name
Last name Takano

Organization

Medical Corporation Hokubukai Utsukushigaoka Hospital

Division name

Center for Clinical Pharmacology

Zip code

004-0839

Address

61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan

TEL

011-882-0111

Email

takano@ughp-cpc.jp


Public contact

Name of contact person

1st name Takuya
Middle name
Last name Matsuda

Organization

Medical Corporation Hokubukai Utsukushigaoka Hospital

Division name

Center for Clinical Pharmacology

Zip code

004-0839

Address

61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan

TEL

011-882-0111

Homepage URL


Email

matsuda@ughp-cpc.jp


Sponsor or person

Institute

Medical Corporation Hokubukai Utsukushigaoka Hospital

Institute

Department

Personal name



Funding Source

Organization

Shiono Chemical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Medical Corporation Hokubukai Utsukushigaoka Hospital Ethics Review Committee

Address

61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan

Tel

011-881-0111

Email

matsuda@ughp-cpc.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

2020 Year 08 Month 24 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

2020 Year 08 Month 03 Day

Date of IRB

2020 Year 08 Month 20 Day

Anticipated trial start date

2020 Year 08 Month 25 Day

Last follow-up date

2020 Year 10 Month 08 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 08 Month 24 Day

Last modified on

2021 Year 01 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047415


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name