UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035286
Receipt number R000040163
Scientific Title Clinical trial on the efficacy on the wrinkle conforming to the guideline of Japanese Cosmetic Science Society
Date of disclosure of the study information 2018/12/19
Last modified on 2019/06/18 09:15:36

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Basic information

Public title

Clinical trial on the efficacy on the wrinkle conforming to the guideline of Japanese Cosmetic Science Society

Acronym

Clinical trial on the efficacy on the wrinkle conforming to the guideline of Japanese Cosmetic Science Society

Scientific Title

Clinical trial on the efficacy on the wrinkle conforming to the guideline of Japanese Cosmetic Science Society

Scientific Title:Acronym

Clinical trial on the efficacy on the wrinkle conforming to the guideline of Japanese Cosmetic Science Society

Region

Japan


Condition

Condition

Healthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the usefulness of wrinkles of the outer corner of the eyes by long-term continuous use of active ingredient formulated cream.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Visual evaluation of wrinkle grade

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Apply the test cosmetic product to the designated left or right half face.

Interventions/Control_2

Apply the placebo cosmetic product to the designated left or right half face.

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

59 years-old >=

Gender

Female

Key inclusion criteria

1) Healthy women aged 30 to 59 years old at the time of acquisition.
2) Individuals who are healthy and are currently not treating with any disease.
3) Individuals who have wrinkles of grade 3 to 5 in the outer corner of the eyes.
4) Individuals who obtained the written consent to participate in the study after explanation of the details of the study and understanding it sufficiently

Key exclusion criteria

1) Individuals who have a history of allergy to cosmetics.
2) Individuals undergoing hormone replacement therapy.
3) Individuals who are pregnant or lactating.
4) Individuals who have experienced cosmetic care that will affect the test site.
5) Individuals who acknowledge that doctors involved in the examination are not appropriate.

Target sample size

70


Research contact person

Name of lead principal investigator

1st name Daiki
Middle name
Last name Kyoutani

Organization

Nikoderm Research Inc.

Division name

Evaluation Division

Zip code

541-0052

Address

1-6-14, Azuchimachi, Chuoku, Osaka, Japan

TEL

06-6125-3501

Email

kyoutani@nikoderm.com


Public contact

Name of contact person

1st name Yuki
Middle name
Last name Yamashita

Organization

Nikoderm Research Inc.

Division name

Evaluation Division

Zip code

541-0052

Address

1-6-14, Azuchimachi, Chuoku, Osaka, Japan

TEL

06-6125-3501

Homepage URL


Email

yamashita@nikoderm.com


Sponsor or person

Institute

Nikoderm Research Inc.

Institute

Department

Personal name



Funding Source

Organization

COSMOS TECHNICAL CENTER 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

Society for Glycative Stress Research

Address

2-13-10, Shinjyuku, Shinjyukuku, Tokyo, Japan

Tel

03-6709-8842

Email

info@toukastress.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

2018 Year 12 Month 19 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

76

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

Terminated

Date of protocol fixation

2018 Year 10 Month 29 Day

Date of IRB

2018 Year 11 Month 29 Day

Anticipated trial start date

2018 Year 12 Month 20 Day

Last follow-up date

2019 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 12 Month 17 Day

Last modified on

2019 Year 06 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040163


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name