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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033232
Receipt No. R000037891
Official scientific title of the study Evaluation of improvement of skin condition by cream cosmetics
Date of disclosure of the study information 2018/07/04
Last modified on 2018/07/02

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Basic information
Official scientific title of the study Evaluation of improvement of skin condition by cream cosmetics
Title of the study (Brief title) Evaluation of improvement of skin condition by cream cosmetics
Region
Japan

Condition
Condition Healthy adult female
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate changes in skin condition when healthy adult female use cosmetics cream for 4 weeks
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of skin condition before starting use of test article and 4 weeks after use
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Using cosmetic essence for 4 consecutive weeks
Interventions/Control_2
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. Subjects whose wrinkle class in the outer corner is 1 to 3
2.Subjects who cares about wrinkles of the forehead
Key exclusion criteria 1. Subjects with cosmetic allergies
2. Subjects who are pregnant or lactating
3. Subjects with inflamed or scraped skin on face
4. Subjects who are judged as unsuitable for the study by the investigator for the other reason
5.Subjects receiving hormone replacement therapy
Target sample size 18

Research contact person
Name of lead principal investigator Masatomo Najima
Organization Japan Clinical Trial Association
Division name N.A.
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Email info@yakujihou.org

Public contact
Name of contact person Takeshi Kaneko
Organization Japan Clinical Trial Association
Division name N.A.
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Homepage URL
Email info@yakujihou.org

Sponsor
Institute Japan Clinical Trial Association
Institute
Department

Funding Source
Organization THE NATURAL HOKKAIDO INC.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 07 Month 04 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 05 Month 17 Day
Anticipated trial start date
2018 Year 07 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 02 Day
Last modified on
2018 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037891

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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