UMIN-CTR Clinical Trial

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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