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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020492
Receipt No. 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

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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
Email 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
Email tobiishi.megumi@kao.co.jp

Sponsor
Institute Kao Corporation
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023663

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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