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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026571
Receipt No. R000030509
Scientific Title Efficacy test of the moisturizer SIR
Date of disclosure of the study information 2017/03/28
Last modified on 2019/03/25

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Basic information
Public title Efficacy test of the moisturizer SIR
Acronym Efficacy test of the moisturizer SIR
Scientific Title Efficacy test of the moisturizer SIR
Scientific Title:Acronym Efficacy test of the moisturizer SIR
Region
North America

Condition
Condition Healthy adults
Classification by specialty
Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the moisturizing activity and the mechanism of the active ingredient for healthy skin
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of water content, transepidermal water loss, visual score and texture before and after the topical application for 2, 4 and 5weeks
Key secondary outcomes Change of cell morphology and the composition of stratum corneum before and after the topical application for 2, 4 and 5weeks

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 formulation including an active ingredient to the one lower leg and the placebo to other lower leg twice daily for 4 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
20 years-old <=
Age-upper limit
70 years-old >=
Gender Female
Key inclusion criteria Healthy females
Key exclusion criteria -Subjects with allergy for the skin care product
-Subjects who are pregnant, planning a pregnancy, or breastfeeding
- Subjects with a history of skin cancer, having active skin cancer, or who are receiving anti-cancer immunosuppressive treatments or medications
-Subjects with a history of immunosuppression/immune deficiency disorders (including (HIV infection or AIDS) or currently using immunosuppressive medications and/or radiation as determined by study documentation One with the plan to receive a medical act during study period
-Subjects currently participating in, or scheduled to participate in, any medical trial, consumer study, or any other clinical study on the body during the study period.
-Subjects who has caused abnormalities in the test site in a past similar study
-Subjects who takes hormone replacement therapy, or are on hormonal birth control
-Subjects who takes medical supplies (insulin, steroid, immunosuppressive drug) which may have an influence on the results
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takatoshi Murase
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 0285-68-2963
Email murase.takatoshi@kao.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takatoshi Murase
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 0285-68-2963
Homepage URL
Email murase.takatoshi@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 Comprehensive Research Group
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 Comprehensive Research Group(USA)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 28 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 10 Day
Date of IRB
2017 Year 03 Month 10 Day
Anticipated trial start date
2017 Year 03 Month 29 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 15 Day
Last modified on
2019 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030509

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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