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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027155
Receipt No. R000031120
Scientific Title The clinical study to examine efficacies of BSL5-170327C and BSL5-170327S on healthy skin
Date of disclosure of the study information 2017/05/15
Last modified on 2017/10/27

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Basic information
Public title The clinical study to examine efficacies of BSL5-170327C and BSL5-170327S on healthy skin
Acronym The clinical study to examine efficacies of BSL5-170327C and BSL5-170327S on healthy skin
Scientific Title The clinical study to examine efficacies of BSL5-170327C and BSL5-170327S on healthy skin
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshito Takahashi
Organization Kao Corporation
Division name Biological Science Research
Zip code
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
1st name
Middle name
Last name Naoki Oya
Organization Kao Corporation
Division name Biological Science Research
Zip code
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)

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(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 15 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 27 Day
Date of IRB
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

Other
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

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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