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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042493
Receipt No. R000048507
Scientific Title A study of healthy adult female to examination of improvement effect of skin functions, including moisturization and skin condition
Date of disclosure of the study information 2020/11/18
Last modified on 2020/11/18

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Basic information
Public title A study of healthy adult female to examination of improvement effect of skin functions, including moisturization and skin condition
Acronym Examination of improvement effect of skin functions
Scientific Title A study of healthy adult female to examination of improvement effect of skin functions, including moisturization and skin condition
Scientific Title:Acronym Examination of improvement effect of skin functions
Region
Japan

Condition
Condition Healthy adult female
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of test food for 12 weeks on the skin's moisturizing function as a placebo control
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Water content of stratum corneum
Key secondary outcomes Transepidermal water loss
VISIA
Skin condition questionnaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of 3 grain of test food per day for 12 consecutive weeks
Interventions/Control_2 Intake of 3 grain of placebo food per day for 12 consecutive weeks
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

Not applicable
Gender Female
Key inclusion criteria 1. Healthy females aged over thirty
2. Subjects who are aware of skin dryness and have low level of water content of stratum corneum
Key exclusion criteria 1.constantly take food, medicine, and etc. that contain the ingredient involved in this study
2.has skin liable to change their condition by wearing a mask, and who could not wear the mask distributed during the study period
3.constantly take food, medicine, and etc. which affects skin condition
4.had a cosmetic surgery which affects the condition of the targeted skin region
5.had a cosmetic surgery or a hormone therapy which affects the condition of the untargeted skin region within 1 year before the screening test
6.had an esthetic treatment within 1 month before the screening test, or who is planning to do so during the study period
7.had long-term sunlight exposure within 1 month before the screening test, or who have a plan to do so during the test period
8.is in the habit of washing up strongly
9.usually use bath additives
10.have wounds or inflammatory diseases which would affect the condition of the targeted skin region
11.have allergic diseases such as hay fever and atopic dermatitis
12.feel roughness on the targeted skin region during the menses period
13.work hours are irregular
14.are planning to go overseas during the study period
15.have asthma or have the possibility to develop asthma during this study
16.have serious diseases or medical history
17.have the possibility to show allergic reaction by consumption the test food
18.have diseases under treatment which affects this study, or who have medical history of serious disease requiring medication
19.are judged inappropriate for the study according to the results of the screening test
20.have participated in other clinical studies within 1 month, or are planning to participate in other clinical studies during this study
21.are pregnant or lactating, or planning to become pregnant or lactate during this study
22.are judged as unsuitable for the study due to lifestyle questionnaire
23.are judged as unsuitable for the study by investigator for other reasons
Target sample size 64

Research contact person
Name of lead principal investigator
1st name Ryota
Middle name
Last name Akagi
Organization Fujicco Co., Ltd.
Division name R&D Laboratories
Zip code 650-8558
Address 6-13-4, Minatojima-nakamachi, Chuo-ku, Kobe-shi, Hyogo
TEL 078-303-5385
Email r-akagi@fujicco.co.jp

Public contact
Name of contact person
1st name Kaori
Middle name
Last name Yoshimura
Organization TTC Co., Ltd.
Division name Clinical Research Planning Department
Zip code 150-0021
Address Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL 03-5459-5329
Homepage URL
Email k.ishida@ttc-tokyo.co.jp

Sponsor
Institute FUJICCO Co., Ltd., Daicel Corporation
Institute
Department

Funding Source
Organization FUJICCO Co., Ltd., Daicel Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Medical Station Clinic Research Ethics Committee
Address 3-12-8, Takaban, Meguroku, Tokyo
Tel 03-6452-2712
Email t.saito@ttc-smo.jp

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

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 18 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 Preinitiation
Date of protocol fixation
2020 Year 11 Month 12 Day
Date of IRB
2020 Year 11 Month 12 Day
Anticipated trial start date
2020 Year 11 Month 19 Day
Last follow-up date
2021 Year 04 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 11 Month 18 Day
Last modified on
2020 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048507

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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