UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy test for evaluating the effect of "composition A" on the skin redness.
Title of the study (Brief title)	Efficacy test of "composition A" to the skin.
Region	Japan

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

Objectives
Narrative objectives1	To confirm effect and mechanism of influence on skin redness by "composition A".
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Skin redness induced by ammonia aqueous solution after 3 days third times consecutive 3 hours application (total 9 hours application in a day) of "composition A" and "placebo"
Key secondary outcomes	Stratum corneum components related with skin redness induced by ammonia aqueous solution after 3 days application (third times consecutive 3 hours application, total 9 hours application in a day) of "composition A" and "placebo" Skin redness induced by ammonia aqueous solution after 3 hours application of "composition A", "placebo" and "composition B". Amount of "composition A" and "composition B" transferred to skin after 3 hours application of "composition A", "placebo" and "composition B".

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	Conduct evaluation 1) to 3) with 2 weeks interval. 1)Wash forearm -> 3 hours application of 3 different concentration of "composition A" and "placebo" -> evaluation of skin redness induced by ammonia aqueous solution. 2)Wash forearm -> 3 hours,3 times,3 days application of 4 different concentration of "composition A" and "placebo". -> evaluation of skin redness induced by ammonia aqueous solution and tape-stripping of stratum corneum. 3)Wash forearm -> 3 hours application of 4 different concentration of "composition A" -> tape-stripping of stratum corneum.
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	49 years-old >=
Gender	Male
Key inclusion criteria	1) 20-49 years old healthy man 2) Men who have healthy and non-troubled skin on their forearm
Key exclusion criteria	-Man who have dermatitis (atopic dermatitis etc.). -Man under-medication. -Man who have experience of skin troubled with products containing ammonium aqueous solution. -Man who is judged as "not eligible" by investigator. For example, man who have sunburned skin, man who have pigmentation, man who have hairy skin, man who have significant skin contour by his mascule and blood vessel.
Target sample size	25

Research contact person
Name of lead principal investigator	Junko Ishikawa
Organization	Kao Corporation
Division name	Biological Science Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7473
Email	ishikawa.junko1@kao.co.jp

Public contact
Name of contact person	Maeko Iwamura
Organization	Kao Corporation
Division name	Biological Science Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7443
Homepage URL
Email	iwamura.maeko@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
Name of secondary funｄer(s)

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	2017 Year 10 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 28 Day
Anticipated trial start date	2017 Year 10 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 10 Month 16 Day
Last modified on	2018 Year 10 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033796