UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026329
Receipt number R000030243
Scientific Title Clinical evaluation of wrinkle improvement by cosmetics
Date of disclosure of the study information 2017/03/02
Last modified on 2017/06/19 11:11:35

* 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

Clinical evaluation of wrinkle improvement by cosmetics

Acronym

Clinical evaluation of wrinkle improvement by cosmetics

Scientific Title

Clinical evaluation of wrinkle improvement by cosmetics

Scientific Title:Acronym

Clinical evaluation of wrinkle improvement by cosmetics

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Dermatology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to reveal that the test cosmetics can reduce eye area wrinkles caused by dryness

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The wrinkle depth evaluated using replica of eye area

Key secondary outcomes

The wrinkle grade evaluated using a picture of eye area


Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Randomized

Randomization unit

Cluster

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Application of the test cosmetics A in one eye area for 4 weeks.
No application of the test cosmetics in another eye area for 4 weeks.

Interventions/Control_2

Application of the test cosmetics B in one eye area for 4 weeks.
No application of the test cosmetics in another eye area for 4 weeks.

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


Not applicable

Gender

Female

Key inclusion criteria

(1)A person who has 1 to 3 wrincle grade in eye area.
(2)A Japanese woman over 30 years old(when a written informed consent was obtained)
(3)A person who consented to participate in this study in the document

Key exclusion criteria

(1)A person who varies in wrinkle grade on the left and right
(2)A person who has factors influencing the test at the evaluation site (those with atopic dermatitis and the like, trauma, burns, inflammation, acne, warts or traces thereof)
(3)A person who has history of beauty care that influence the test at the evaluation site, or those who plans to receive it during the study period
(4)A person who received special treatment (facial esthetics etc.) at the evaluation site within the past 3 months, or who will receive it during the study period
(5)Pregnant or lactating
(6)A person who has experienced severe disease (allergy, etc.) against cosmetics
(7)A person who continues to use cosmetics, health foods, etc. that indicate or appeal the efficacy related to this study to the evaluation site
(8)A person judged as ineligible by the investigator with other reasons

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhiko Takano

Organization

Medical Corporation Hokubukai Utsukushigaoka Hospital

Division name

Center for Clinical Pharmacology

Zip code


Address

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

TEL

011-882-0111

Email

wakimoto@ughp-cpc.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ryota Wakimoto

Organization

Medical Corporation Hokubukai Utsukushigaoka Hospital

Division name

Center for Clinical Pharmacology

Zip code


Address

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

TEL

011-882-0111

Homepage URL


Email

wakimoto@ughp-cpc.jp


Sponsor or person

Institute

Medical Corporation Hokubukai Utsukushigaoka Hospital

Institute

Department

Personal name



Funding Source

Organization

Noevir 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


Address


Tel


Email



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

医療法人北武会 美しが丘病院(北海道) Medical Corporation Hokubukai Utsukushigaoka Hospital


Other administrative information

Date of disclosure of the study information

2017 Year 03 Month 02 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

2017 Year 02 Month 16 Day

Date of IRB


Anticipated trial start date

2017 Year 03 Month 02 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 02 Month 28 Day

Last modified on

2017 Year 06 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030243


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name