UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024603 |
|---|---|
| Receipt number | 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 17:42:30 |
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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
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
katou.arisa@kao.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028311
