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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000035286
Receipt No. 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

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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
Institute Nikoderm Research Inc.
Institute
Department

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
URL(English) https://upload.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


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