UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for the efficacy of BSL-0051 and BSL-0052 on healthy skin
Title of the study (Brief title)	A study for the efficacy of BSL-0051 and BSL-0052 on healthy skin
Region	Japan

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

Objectives
Narrative objectives1	Efficacy evaluation of BSL-0051 and BSL-0052 on the skin conditions of healthy males. BSL-0051 and BSL-0052 are used as the code names of the materials.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of the sebum content, the sebum composition, the gene expressions, the skin moisture content, the transepidermal water loss and the skin color and the dermatological assessment before and after the application of BSL-0051 and BSL-0052 for 4 weeks.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Panelists will apply placebo toner on the both sides of their face twice a day for 1 week. Subsequently panelists will apply placebo toner to one side and BSL-0051- contained toner to another side of their faces twice a day for 4 weeks. About a month later, panelists will apply placebo toner on the both sides of their face twice a day for 1 week again. After that panelists will apply placebo toner to one side and BSL-0052-contained toner to another side of their faces twice a day for 4 weeks.
Interventions/Control_2	Panelists will apply placebo toner on the both sides of their faces twice a day for 1 week. After that panelists will apply placebo toner to one side and BSL-0052-contained toner to another side of their faces twice a day for 4 weeks. About a month later, panelists will apply placebo toner again on the both sides of their faces twice a day for 1 week. Subsequently panelists will apply placebo toner to one side and BSL-0051-contained toner to another side of their faces twice a day for 4 weeks.
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	Male
Key inclusion criteria	Panelists who are Japanese males ranging from 20-59 years old.
Key exclusion criteria	1.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. Panelists especially with any skin irritation, skin condition (such as rosacea, eczema, atopic dermatitis, or psoriasis), or severe acne on their faces. 2.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. 3.Panelists under the care of a doctor taking prescription medication (topical) for any facial skin issues. 4.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. 5.Panelists who refrain from sun exposure, tanning beds, sunless tanners, and skin lightening products until the study completes. 6.Panelists currently participating in, or scheduled to participate in, another facial study during the study period. 7.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	10

Research contact person
Name of lead principal investigator	Yoshito Takahashi
Organization	Kao Corporation
Division name	R&D -Core Technology- 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	Arisa Katou
Organization	Kao Corporation
Division name	R&D -Core Technology- Biological Science Research
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	0285-68-7498
Homepage URL
Email	katou.arisa@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	2016 Year 11 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 14 Day
Anticipated trial start date	2016 Year 09 Month 16 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	2016 Year 10 Month 28 Day
Last modified on	2017 Year 04 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028311