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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025455
Receipt No. 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

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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
Email 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
Email endou.youko1@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 701 Research, Inc
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029293

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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