UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020492 |
|---|---|
| Receipt number | R000023663 |
| Scientific Title | A study to see the efficacy of the lotion (Development code:K8284410) on facial skin condition with Japanese women |
| Date of disclosure of the study information | 2016/01/07 |
| Last modified on | 2016/03/10 01:10:26 |
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Basic information
Public title
A study to see the efficacy of the lotion (Development code:K8284410) on facial skin condition with Japanese women
Acronym
A study to see the efficacy of the lotion (Development code:K8284410) on facial skin condition with Japanese women
Scientific Title
A study to see the efficacy of the lotion (Development code:K8284410) on facial skin condition with Japanese women
Scientific Title:Acronym
A study to see the efficacy of the lotion (Development code:K8284410) on facial skin condition with Japanese women
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy of Sample X on facial skin condition with healthy female skin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of dermatological assessment, measurement of skin color and that of skin shape before and after the repeated treatments of the lotions for 4 and 8 weeks.
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
Application of the sample lotion and the placebo lotion on one of the half-faces and another, 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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy Japanese females with more than one pair of similar spots on both half-faces
Key exclusion criteria
Subjects with severe systemic diseases and/or skin diseases
Subjects who are pregnant and/or who had a childbirth within 2 years
Subjects who are receiving hormone therapies
Subjects who have laser treatments for facial pigmentation (spot, bruise, etc.), acne etc.
Subjects with severe sunburn or subjects who might possibly severe sunburn during the test period
Subjects with sensitive skins
Subjects seemed to be inappropriate to participate in this study according to the decision by investigators and/or doctors
Target sample size
20
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 | Megumi Tobiishi |
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
tobiishi.megumi@kao.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Self funding
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
H27-A072
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
| 2016 | Year | 01 | Month | 07 | 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
| 2015 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 05 | 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 | 01 | Month | 07 | Day |
Last modified on
| 2016 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023663
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
