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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026329
Receipt No. 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

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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
Institute Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department

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
URL(English) https://upload.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


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