UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy test of the moisturizer SIR
Acronym	Efficacy test of the moisturizer SIR
Scientific Title	Efficacy test of the moisturizer SIR
Scientific Title:Acronym	Efficacy test of the moisturizer SIR
Region	North America

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

Objectives
Narrative objectives1	To confirm the moisturizing activity and the mechanism of the active ingredient for healthy skin
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of water content, transepidermal water loss, visual score and texture before and after the topical application for 2, 4 and 5weeks
Key secondary outcomes	Change of cell morphology and the composition of stratum corneum before and after the topical application for 2, 4 and 5weeks

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	Apply the formulation including an active ingredient to the one lower leg and the placebo to other lower leg twice daily for 4 weeks
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	70 years-old >=
Gender	Female
Key inclusion criteria	Healthy females
Key exclusion criteria	-Subjects with allergy for the skin care product -Subjects who are pregnant, planning a pregnancy, or breastfeeding - Subjects with a history of skin cancer, having active skin cancer, or who are receiving anti-cancer immunosuppressive treatments or medications -Subjects with a history of immunosuppression/immune deficiency disorders (including (HIV infection or AIDS) or currently using immunosuppressive medications and/or radiation as determined by study documentation One with the plan to receive a medical act during study period -Subjects currently participating in, or scheduled to participate in, any medical trial, consumer study, or any other clinical study on the body during the study period. -Subjects who has caused abnormalities in the test site in a past similar study -Subjects who takes hormone replacement therapy, or are on hormonal birth control -Subjects who takes medical supplies (insulin, steroid, immunosuppressive drug) which may have an influence on the results -Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takatoshi Murase
Organization	Kao Corporation
Division name	R&D -Core Technology-Biological Science Research
Zip code
Address	2606 Akabane, Ichikai-Machi, Haga-Gun, TOCHIGI, 321-3497, JAPAN
TEL	0285-68-2963
Email	murase.takatoshi@kao.co.jp

Public contact
Name of contact person	1st name Middle name Last name Takatoshi Murase
Organization	Kao Corporation
Division name	R&D -Core Technology-Biological Science Research
Zip code
Address	2606 Akabane, Ichikai-Machi, Haga-Gun, TOCHIGI, 321-3497, JAPAN
TEL	0285-68-2963
Homepage URL
Email	murase.takatoshi@kao.co.jp

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	Comprehensive Research Group
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	Comprehensive Research Group(USA)

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 28 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	Completed
Date of protocol fixation	2017 Year 03 Month 10 Day
Date of IRB	2017 Year 03 Month 10 Day
Anticipated trial start date	2017 Year 03 Month 29 Day
Last follow-up date	2018 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	2017 Year 03 Month 15 Day
Last modified on	2019 Year 03 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030509

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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