UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027155 |
|---|---|
| Receipt number | 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 07:47:30 |
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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
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
ooya.naoki@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（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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031120
| Research Plan | |
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| Registered date | File name |
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