UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025455 |
|---|---|
| Receipt number | R000029293 |
| Scientific Title | A study on the dermatological efficacy of lotion (BSL05-161025E) |
| Date of disclosure of the study information | 2017/01/10 |
| Last modified on | 2018/01/17 10:05:03 |
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Basic information
Public title
A study on the dermatological efficacy of lotion (BSL05-161025E)
Acronym
A study on the dermatological efficacy of lotion (BSL05-161025E)
Scientific Title
A study on the dermatological efficacy of lotion (BSL05-161025E)
Scientific Title:Acronym
A study on the dermatological efficacy of lotion (BSL05-161025E)
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the dermatological efficacy of lotion (BSL05-161025E) for healthy female skin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of dermatological assessment, wrinkle assessment, skin water content, transepidermal water loss and skin elasticity before and after the repeated treatment for 4 and 8 weeks with the lotions.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Apply the test lotion and the placebo lotion on one half of the face and the other side, respectively, twice a day for 8 weeks.
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Healthy Japanese females with wrinkle grading score from 2.75 to 3.25
Key exclusion criteria
-Subjects with sensitive skin or allergy against facial cleanser or cosmetic products
-Subjects with skin diseases such as atopic dermatitis, psoriasis and severe acne
-Subjects with pollen allergy
-Subjects seemed inappropriate to participate in this study by the principle investigator
-Subjects who have medical treatment or take some medicine for their facial skin
Target sample size
30
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
3-28, 5-chome, Kotobuki-cho, Odawara, 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 | Yoko Endo |
Organization
Kao Corporation
Division name
R&D -Core Technology- Biological Science Research
Zip code
Address
3-28, 5-chome, Kotobuki-cho, Odawara, Kanagawa, 250-0002, JAPAN
TEL
0465-34-6116
Homepage URL
endou.youko1@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
701 Research, Inc
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
H29-A001
Org. issuing International ID_1
701 Research, Inc
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
株式会社セブンオーワンリサーチ Above Access（東京）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 10 | 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
After repeated treatment of the lotion, improvement of wrinkle grade, increase of water content of stratum corneum, improvement of skin elasticity were observed.
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 | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 04 | Month | 14 | Day |
Date analysis concluded
| 2017 | Year | 07 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 28 | Day |
Last modified on
| 2018 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029293
