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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042427
Receipt No. R000048438
Scientific Title A Study on skin improving effects of a pseudo-ceramide containing formulation for sensitive skin
Date of disclosure of the study information 2020/11/16
Last modified on 2020/11/12

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Basic information
Public title Evaluation of a pseudo-ceramide containing formulation
Acronym Evaluation of a pseudo-ceramide containing formulation
Scientific Title A Study on skin improving effects of a pseudo-ceramide containing formulation for sensitive skin
Scientific Title:Acronym 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 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of transepidermal water loss, stratum corneum water content and dermatological assessment after treatments for 1 or 2 weeks.
Key secondary outcomes Evaluation of the skin surface images, questionnaire survey and VAS after treatments for 1 or 2 weeks.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Apply the water based model lotion and the model emulsion on facial skin twice a day for a week.
After that, apply the pseudo-ceramide containing formulation in addition to above model lotions and emulsion once a day for 2 weeks.
Interventions/Control_2 Apply the water based model lotion and the model emulsion on facial skin twice a day for three 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
59 years-old >=
Gender Female
Key inclusion criteria 1. Females who are 20-59 years old
2. Subjects who have sensitive skin consciousness.
3. Subjects who have dry skin consciousness.
4. Subjects who apply to one or more following questions.
a. I need to use skin care products twice a day on my face.
b. Cosmetics and medicines have caused redness, drying and irritation to my skin.
c. I use cosmetic products for sensitive skin.
5. Subjects who use face wash at least 5 days a week
6. Subjects who use lotion or all-in-one cosmetics at least 5 days a week
Key exclusion criteria 1. Subjects who are pregnancy, lactation, or subjects who may become pregnant very soon.
2. Subjects with serious underlying diseases.
3. Subjects who have clear skin symptoms at the test site.
4. Subjects who are currently undergoing hospital treatment with atopic dermatitis
5. Subjects who have had atopic dermatitis symptoms in their face within the present or past year
6. Subjects who are currently treating the skin of the face
7. Subjects who are currently using external drugs (prescription drugs, over-the-counter drugs) on the skin of the face
8. Subjects who are currently participating in product monitor surveys involving testing of the use of other drugs or with the use of quasi-drugs, cosmetics, and facial devices
9. Subjects who are determined to be not appropriate by investigator.

Target sample size 55

Research contact person
Name of lead principal investigator
1st name Kazuhiro
Middle name
Last name Kaizu
Organization Kao Corporation
Division name R&D Skin Care Products Research
Zip code 250-0002
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
1st name Seri
Middle name
Last name Akiyama
Organization Kao Corporation
Division name R&D Skin Care Products Research
Zip code 250-0002
Address 5-3-28, Kotobukicho, Odawara, Kanagawa, 250-0002, Japan
TEL 0465-34-0559
Homepage URL
Email akiyama.seri@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)

IRB Contact (For public release)
Organization Human Research Ethics Committee, Kao Corporation
Address 2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel +81-3-5630-7263
Email morisaki.naoko@kao.com

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 株式会社セブンオーワンリサーチ(東京都)

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 16 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 55
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 No longer recruiting
Date of protocol fixation
2020 Year 09 Month 24 Day
Date of IRB
2020 Year 09 Month 24 Day
Anticipated trial start date
2020 Year 11 Month 04 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 11 Month 12 Day
Last modified on
2020 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048438

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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