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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038552
Receipt No. R000043928
Scientific Title Study to examine the effect of humidity and formulation membrane on skin properties (2)
Date of disclosure of the study information 2019/12/01
Last modified on 2019/12/03

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Basic information
Public title Study of humidity and membrane for skin properties
Acronym Study of humidity and membrane for skin properties
Scientific Title Study to examine the effect of humidity and formulation membrane on skin properties (2)
Scientific Title:Acronym Study of humidity and membrane for skin properties
Region
Japan

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

Objectives
Narrative objectives1 To examine the effect for healthy skin properties by staying in the specified humidity environment and by covering the formulation membrane.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes water content, transepidermal water loss, skin color, surface texture and sebum composition
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 Treatment
Type of intervention
Other
Interventions/Control_1 To stay 6 hours a day in each environments (low and middle humidity). To apply the formulation membrane on only the half face for 6 hours during stay in low humidity environment.
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
20 years-old <=
Age-upper limit
59 years-old >=
Gender Female
Key inclusion criteria Healthy females
Key exclusion criteria 1.Subjects who has become pregnant and breast-feeding or have a possibility of pregnant during the study period.
2.Subjects with illnesses or diseases on their face, especially such as atopic dermatitis, or psoriasis, or severe acne.
3.Subjects who has serious suntan in their faces.
4.Subjects who performs outdoor sport periodically.
5.Subjects who take any OTC or prescription medications, especially anti-inflammation agents, anti-bacterial agents, analgesic agents, hormonal agents, laxative agents, intestinal agents, etc.
6.Subjects who attend the hospital (such as gastrointestinal disease, liver disease, kidney disease, cardiovascular heart disease, skin disease, or poor physical condition). And, panelists for less than one month after attend the hospital.
7.Subjects who has seen in a spa treatment (such as chemical peeling, or laser therapy). And, panelists who has seen in a cosmetic medicine (such as cosmetic surgery, or collagen infusion).
8.Subjects who cannot refrain from facial cleansing on the days of evaluation visits.
9.Subjects who cannot agree with not used mask on the days of evaluation visits.
10.Subjects who are participating or plan to participate in other intervention tests (cosmetics, foods) for facial skin during the test period.
11.Subjects deemed inappropriate to participate in this study by the principle investigator.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Junko
Middle name
Last name Ishikawa
Organization Kao Corporation
Division name Biological Science Research
Zip code 321-3497
Address 2606 Akabane, Ichikai-Machi, Haga-Gun, TOCHIGI, 321-3497, JAPAN
TEL 0285-68-7888
Email ishikawa.junko1@kao.com

Public contact
Name of contact person
1st name Akane
Middle name
Last name Kawamoto
Organization Kao Corporation
Division name Biological Science Research
Zip code 321-3497
Address 2606 Akabane, Ichikai-Machi, Haga-Gun, TOCHIGI, 321-3497, JAPAN
TEL 0285-68-7888
Homepage URL
Email kawamoto.akane@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 花王株式会社(栃木県)

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 01 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
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
2019 Year 11 Month 20 Day
Date of IRB
2019 Year 11 Month 20 Day
Anticipated trial start date
2019 Year 12 Month 01 Day
Last follow-up date
2020 Year 02 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 12 Day
Last modified on
2019 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=R000043928

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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