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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035116
Receipt No. R000040027
Official scientific title of the study Influence on skin condition due to difference in application method of cosmetics
Date of disclosure of the study information 2018/12/04
Last modified on 2018/12/03

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Basic information
Official scientific title of the study Influence on skin condition due to difference in application method of cosmetics
Title of the study (Brief title) Influence on skin condition due to difference in application method of cosmetics
Region
Japan

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

Objectives
Narrative objectives1 Compare changes in skin condition due to differences in cosmetic application method
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the moisture content of the skin, the texture of the skin, wrinkles
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Use a cosmetic product of 5 items using a massage and a light pressure applied application method
Interventions/Control_2 Use a cosmetic product of 5 items
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
35 years-old <=
Age-upper limit
49 years-old >=
Gender Female
Key inclusion criteria 1. Subjects whose wrinkle class in the outer corner is 1 to 3
2. Subjects whose skin is dry
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
Target sample size 36

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 Faith Co., Ltd.
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 12 Month 04 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 15 Day
Anticipated trial start date
2018 Year 12 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 12 Month 03 Day
Last modified on
2018 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040027

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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