UMIN-CTR Clinical Trial

Basic information
Public title	Effect of treatment with plant extracts on skin properties
Acronym	Effect of treatment with plant extracts on skin properties
Scientific Title	Effect of treatment with plant extracts on skin properties
Scientific Title:Acronym	Effect of treatment with plant extracts on skin properties
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of treatment with plant extract on expression of antimicrobial peptide and bactericidal action in healthy human skin
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Indices with regard to skin barrier; expression level of antimicrobial peptide and bactericidal action
Key secondary outcomes	Indices with regard to skin conditions; skin physiological parameters such as skin conductance and TEWL

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	8
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Apply test product A to the left palm and medial forearm, and placebo to the right palm and medial forearm, twice a day for 7 days in the first half investigation. After washout period of 3 weeks, apply test product B to the left palm and medial forearm, and placebo to the right palm and medial forearm, twice a day for 7 days, in the second half investigation.
Interventions/Control_2	Apply test product A to the left palm and medial forearm, and placebo to the right palm and medial forearm, twice a day for 7 days in the first half investigation. After washout period of 3 weeks, apply placebo to the left palm and medial forearm, and test product B to the right palm and medial forearm, twice a day for 7 days, in the second half investigation.
Interventions/Control_3	Apply placebo to the left palm and medial forearm, and test product A to the right palm and medial forearm, twice a day for 7 days in the first half investigation. After washout period of 3 weeks, apply test product B to the left palm and medial forearm, and placebo to the right palm and medial forearm, twice a day for 7 days, in the second half investigation.
Interventions/Control_4	Apply placebo to the left palm and medial forearm, and test product A to the right palm and medial forearm, twice a day for 7 days in the first half investigation. After washout period of 3 weeks, apply placebo to the left palm and medial forearm, and test product B to the right palm and medial forearm, twice a day for 7 days, in the second half investigation.
Interventions/Control_5	Apply test product B to the left palm and medial forearm, and placebo to the right palm and medial forearm, twice a day for 7 days in the first half investigation. After washout period of 3 weeks, apply test product A to the left palm and medial forearm, and placebo to the right palm and medial forearm, twice a day for 7 days, in the second half investigation.
Interventions/Control_6	Apply test product B to the left palm and medial forearm, and placebo to the right palm and medial forearm, twice a day for 7 days in the first half investigation. After washout period of 3 weeks, apply placebo to the left palm and medial forearm, and test product A to the right palm and medial forearm, twice a day for 7 days, in the second half investigation.
Interventions/Control_7	Apply placebo to the left palm and medial forearm, and test product B to the right palm and medial forearm, twice a day for 7 days in the first half investigation. After washout period of 3 weeks, apply test product A to the left palm and medial forearm, and placebo to the right palm and medial forearm, twice a day for 7 days, in the second half investigation.
Interventions/Control_8	Apply placebo to the left palm and medial forearm, and test product B to the right palm and medial forearm, twice a day for 7 days in the first half investigation. After washout period of 3 weeks, apply placebo to the left palm and medial forearm, and test product A to the right palm and medial forearm, twice a day for 7 days, in the second half investigation.
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	49 years-old >=
Gender	Male
Key inclusion criteria	1.Informed consent provided 2.Able to follow the instruction of the study team
Key exclusion criteria	1.Subjects with injury such as wound or eczema on hands or forearms 2.Subjects with severe sunburn on hands or forearms 3.Subjects with atopic dermatitis or contact skin hypersensitivity 4.Subjects who need a routine visit to a clinic or regular medication 5.Subjects who participate in other research or treatment with physical loads that affect this test 6.Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Takuya Mori
Organization	Kao Corporation
Division name	Biological Science Research
Zip code
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7769
Email	mori.takuya@kao.com

Public contact
1st name of contact person	1st name Middle name Last name Shigeyuki Ono
Organization	Kao Corporation
Division name	Biological Science Research
Zip code
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7687
Homepage URL
Email	ono.shigeyuki@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
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	花王株式会社（栃木県）

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 20 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	2018 Year 06 Month 20 Day
Date of IRB	2018 Year 06 Month 20 Day
Anticipated trial start date	2018 Year 08 Month 21 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	2018 Year 08 Month 09 Day
Last modified on	2019 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038382