UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039183 |
|---|---|
| Receipt number | R000044439 |
| Scientific Title | A study for the skin moisturizing effect of a food intake in adult female who are aware of skin dryness |
| Date of disclosure of the study information | 2020/01/19 |
| Last modified on | 2020/07/03 11:53:02 |
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Basic information
Public title
A study for the skin moisturizing effect of a food intake in adult female who are aware of skin dryness
Acronym
A study for the skin moisturizing effect of a food intake in adult female who are aware of skin dryness
Scientific Title
A study for the skin moisturizing effect of a food intake in adult female who are aware of skin dryness
Scientific Title:Acronym
A study for the skin moisturizing effect of a food intake in adult female who are aware of skin dryness
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and skin moisturizing effect of intake of test food for 8 weeks
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
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 a test food per day for 8 consecutive weeks
Interventions/Control_2
Intake of a placebo food per day for 8 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
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Healthy females from 30 to 49 years of age
2.Subjects who are aware of skin dryness and lower level of water content of stratum corneum
Key exclusion criteria
Subjects
1. who constantly use medicine, health food and general food that contain the ingredient involved in this study
2.who usually take a food, medicine, functional food, etc. which would affect skin condition
3.who have got cosmetic surgery which would affect the targeted skin
4.who have got cosmetic surgery or hormone therapy which would affect the skin other than targeted skin within 1 year before the screening test
5.who have got esthetic treatment would affect the targeted skin within 1 month before the screening test or plan the act
6.who have had ultraviolet exposure within 1 month before the screening test or plan to do
7.who wash the body using a nylon towel, etc. which provides strong skin irritation
8.who usually use bath additives
9.who have the wounds or inflammatory diseases which would affect the targeted skin
10.who have had a symptom of pollinosis during between January to April in the past 3 years or who are expected to have allergic symptoms on the skin during this study
11.who feel skin roughness on the targeted skin around the menses
12.who work on a pre-dawn shift or on night duty more than 2 times during this study
13.who are planning to go overseas
14.who have asthma or would have asthma during this study
15.who have serious diseases or medical history
16.who have allergic reaction related to this study
17.who have diseases under treatment affecting this study or who have medical history of serious disease requiring medication
18.who are judged inappropriate for the study according to the results of screening test
19.who have participated in other clinical studies within 1 month, or are planning to participate in other clinical studies during this study
20.who are pregnant or lactating, or plan to become pregnant or lactate during this study
21.who are judged as unsuitable for the study due to lifestyle questionnaire
22.who are judged as unsuitable for the study by investigator for other reasons
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazuya |
| Middle name | |
| Last name | Souda |
Organization
SHINMEI KITCHEN Co., LTD.
Division name
Management department, Production section
Zip code
650-0023
Address
6-1-21 Sakaemachi-dori, Chuo-ku, Kobe, Hyogo
TEL
078-371-2426
souda-kazuya@akafuji.co.jp
Public contact
Name of contact person
| 1st name | Kyohei |
| Middle name | |
| Last name | Hashimoto |
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
k.hashimoto@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
SHINMEI KITCHEN Co., LTD.
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
Aisei Hospital Ueno Clinic Research Ethics Committee
Address
2-18-6, Higashiueno, Taitou-ku, Tokyo
Tel
03-6455-0880
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 | 01 | Month | 19 | 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
50
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
| 2019 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 21 | 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 | 01 | Month | 17 | Day |
Last modified on
| 2020 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044439
| Research Plan | |
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| 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 |
