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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035170
Receipt No. R000040086
Official scientific title of the study A Study on skin improving effects of a pseudo-ceramide containing formulation
Date of disclosure of the study information 2019/02/07
Last modified on 2018/12/13

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Basic information
Official scientific title of the study A Study on skin improving effects of a pseudo-ceramide containing formulation
Title of the study (Brief title) Evaluation of a pseudo-ceramide containing formulation
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the efficacy of a pseudo-ceramide formulation on the skin of healthy females
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of the transepidermal water loss,after treatments for 4 weeks use with the pseudo-ceramide containing formulation
Key secondary outcomes Evaluation of the stratum corneum water content,transepidermal water loss,sebum secretion,skin color,skin viscoelasticity,stratum corneum,dermatological assessment,a questionnaire survey and VAS after treatments for 4 weeks use with the pseudo-ceramide containing formulation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Apply the model water based lotion and model lotion on facial skin for twice a day for a week.
And apply the pseudo-ceramide containing formulation and model lotion on facial skin for twice a day for 4 weeks.
Also apply the pseudo-ceramide formulation on legs' skin for twice a day for 4 weeks.
Interventions/Control_2 Apply the model water based lotion and model lotion on facial skin for twice a day for a week.
And apply the water based lotion on the market and model lotion on facial skin for twice a day for 4 weeks.
Also apply the water based lotion on the market on legs' skin for twice a day 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
20 years-old <=
Age-upper limit
49 years-old >=
Gender Female
Key inclusion criteria 1.Healthy female aged from 20 to 49 years old.
2.Subjects who have sensitive and dry skin consciousness.
3.Subjects who can agree to participate in the study voluntarily in writing.
4.Subjects who can agree to change her currently-using cosmetics to designated ones during the test period.
Key exclusion criteria 1.Subjects who has abnormalities in the skin of the measurement regions
2.Subjects who regularly goes to hospital.
3.Subjects with the anamnesis of an alcohol or a drug dependence.
4.Subjects who regularly use drugs (hypnotic drug, anti-allergic drug, analgetic drug, hormonal drug, laxative, antiflatulent etc...).
5.Subjects who has possibilities for emerging allergy to cosmetics and/or foods (including experiences of skin irritation by cosmetics within a year).
6.Subjects who has allergy to adhesive tape and/or medical tape.
7.Subjects who suffers pollen allergy, severe rhinitis and atopic dermatitis.
8.Subjects who is pregnant or lactating, or planned to become pregnant during a test period.
9.Subjects who participates in the other clinical studies within 4 weeks in the past, or person who scheduled to participate in other clinical studies during the test period.
10.Subjects who is judged as unsuitable for the study by the investigator for other reasons.
11.Subjects who herself and/or her family members are working for the cosmetics company, the food company, an advertising agency, investigation and consultant business, and a mass media-related company.
12.Person who experienced medical cosmetic treatments (i.e. cosmetic surgery, collagen injection etc..)
Target sample size 60

Research contact person
Name of lead principal investigator Kazuhiro Kaizu
Organization Kao Corporation
Division name R&D Skin Care Products Research
Address 5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, Japan
TEL 0465-34-0559
Email kaizu.kazuhiro@kao.com

Public contact
Name of contact person Daisuke Watanabe
Organization Kao Corporation
Division name R&D Skin Care Products Research
Address 5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, Japan
TEL 0465-34-0559
Homepage URL
Email watanabe.daisuke2@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
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 花王株式会社(神奈川県)

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 07 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2019 Year 01 Month 24 Day
Anticipated trial start date
2019 Year 02 Month 07 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 07 Day
Last modified on
2018 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040086

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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