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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024603
Receipt No. R000028311
Scientific Title A study for the efficacy of BSL-0051 and BSL-0052 on healthy skin
Date of disclosure of the study information 2016/11/01
Last modified on 2017/04/26

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Basic information
Public title A study for the efficacy of BSL-0051 and BSL-0052 on healthy skin
Acronym A study for the efficacy of BSL-0051 and BSL-0052 on healthy skin
Scientific Title A study for the efficacy of BSL-0051 and BSL-0052 on healthy skin
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshito Takahashi
Organization Kao Corporation
Division name R&D -Core Technology- 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 Arisa Katou
Organization Kao Corporation
Division name R&D -Core Technology- Biological Science Research
Zip code
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)

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
2016 Year 11 Month 01 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
2016 Year 09 Month 14 Day
Date of IRB
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

Other
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

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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