UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The clinical study to examine efficacies of BSL5-170327C and BSL5-170327S on healthy skin
Title of the study (Brief title)	The clinical study to examine efficacies of BSL5-170327C and BSL5-170327S on healthy skin
Region	Japan

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

Objectives
Narrative objectives1	Evaluation of the efficacy of BSL5-170327C and BSL5-170327S on healthy skin. BSL5-170327C and BSL5-170327S are used as the code name of the materials.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of the dermatological assessment, sebum composition, gene expressions, skin moisture content, and transepidermal water loss before and after the application of BSL5-170327C, as well as the continuous applications of both BSL5-170327C and BSL5-170327S.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Panelists will apply BSL5-170327C on their full face twice a day for 3 weeks, and then cleanse with launched product followed by placebo toner twice a day for 2 weeks.
Interventions/Control_2	Panelists will apply BSL5-170327C on their full face twice a day for 3 weeks, and then cleanse with launched product followed by BSL5-170327S twice a day for 2 weeks.
Interventions/Control_3	Panelists will apply launched product on their full face twice a day for 3 weeks, and then cleanse with launched product followed by placebo toner twice a day for 2 weeks.
Interventions/Control_4	Panelists will apply launched product on their full face twice a day for 3 weeks, and then cleanse with launched product followed by BSL5-170327S twice a day for 2 weeks.
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	Panelists who are Japanese males ranging from 20-49 years old.
Key exclusion criteria	-Panelists with illnesses or diseases which in the opinion of the investigators, might interfere with the conduct of the study or the interpretation of results. Especially panelists with any skin irritation, skin condition (such as rosacea, eczema, atopic dermatitis, or psoriasis), or severe acne on their faces. -Panelists who take any supplements, OTC or prescription medications, especially anti-inflammation agents, anti-bacterial agents, analgesic agents, hormonal agents, laxative agents, intestinal agents, etc. -Panelists under the care of a doctor taking prescription medication (topical) for any facial skin issues. -Panelists who have used any pore strips within 2 weeks of the first visit. -Panelists who tend to have noticeable beard and whisker hair within 1 day after shaving. -Panelists with allergy or sensitivity to any facial care product, facial moisturizer, facial cleanser, pore strip, or to any specific ingredient or fragrance used in these types of products. -Panelists who cannot refrain from sun exposure, tanning beds, sunless tanners, pore strips, and skin lightening products until the study completes. -Panelists who cannot refrain from facial cleansing and shaving on the days of evaluation visits. -Panelists currently participating in, or scheduled to participate in, another facial study during the study period. -Panelists having any conditions which in the opinion of the investigators, might interfere with the conduct of the study or the interpretation of results.
Target sample size	40

Research contact person
Name of lead principal investigator	Yoshito Takahashi
Organization	Kao Corporation
Division name	Biological Science Research
Address	5-3-28, Kotobuki-machi, Odawara-shi, Kanagawa, 250-0002, JAPAN
TEL	0465-34-6116
Email	takahashi.yoshito@kao.co.jp

Public contact
Name of contact person	Naoki Oya
Organization	Kao Corporation
Division name	Biological Science Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7498
Homepage URL
Email	ooya.naoki@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（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 27 Day
Anticipated trial start date	2017 Year 05 Month 19 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 04 Month 27 Day
Last modified on	2017 Year 10 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031120