UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035797 |
|---|---|
| Receipt number | R000040775 |
| Scientific Title | A study for the skin moisturizing effect of a beverage intake on in adult female who are aware of skin dryness (Preliminary test) |
| Date of disclosure of the study information | 2019/02/07 |
| Last modified on | 2019/06/20 13:06:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study for the skin moisturizing effect of a beverage intake on in adult female who are aware of skin dryness (Preliminary test)
Acronym
A study for the skin moisturizing effect of a beverage intake
Scientific Title
A study for the skin moisturizing effect of a beverage intake on in adult female who are aware of skin dryness (Preliminary test)
Scientific Title:Acronym
A study for the skin moisturizing effect of a beverage intake
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
Stratum corneum water content
Key secondary outcomes
Transepidermal water loss
VISIA
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of 2 test foods per day for 8 consecutive 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
| 64 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Healthy females from 20 to 64 years of age
2.Subjects who are aware of skin dryness and lower level of Stratum corneum water content
Key exclusion criteria
Subjects
1.who usually drink hard water or mineral water
2.who usually take some foods, drugs, functional foods, etc. which would affect skin condition
3.who got some cosmetic surgery which would affect the target skins
4.who got some cosmetic surgery, or hormone therapy which would affect the Other than target skins within 1 year before the screening test
5.who got esthetic treatments would affect the target skins within 1 month before the screening test, or plan the act
6.who plan to have ultraviolet exposure within 1 month before the screening test
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 target skins
10.who might have symptom of pollinosis during between February 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 target skin around a menstruates
12.who employ on a pre-dawn shift or on night duty more than 2 times in this study
13.who are planning to go overseas
14.who have asthma or would have asthma during this study
15.who have or has medical history serious disease
16.who have allergic reaction related to this study or who cannot ingest carbonated beverages
17.who have disease under treatment or who have serious disease medical history requiring medication treatment affecting this study
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 due to lifestyle questionnaire
22.who are judged as unsuitable for the study by investigator for other reasons
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasumasa Sugiura |
Organization
Georgia Premium Foods
Division name
-
Zip code
Address
3-6-9, Shiba Minato-ku, Tokyo
TEL
03-6275-1023
sugiura@nabeghlavi.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyohei Hashimoto |
Organization
TTC Co., Ltd.
Division name
Clinical Research Planning Department
Zip code
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
Georgia Premium Foods
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
Address
Tel
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
| 2019 | Year | 02 | 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
10
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 | 01 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 05 | 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
| 2019 | Year | 02 | Month | 07 | Day |
Last modified on
| 2019 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040775
