UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042296 |
|---|---|
| Receipt number | R000048286 |
| Scientific Title | A study of healthy adult men and women with dry skin to examine the effects of food intake on skin function, including moisturization and skin condition. |
| Date of disclosure of the study information | 2022/03/07 |
| Last modified on | 2020/11/06 13:59:51 |
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Basic information
Public title
A study of healthy adult men and women with dry skin to examine the effects of food intake on skin function, including moisturization and skin condition.
Acronym
A study of healthy adult men and women with dry skin to examine the effects of food intake on skin function, including moisturization and skin condition.
Scientific Title
A study of healthy adult men and women with dry skin to examine the effects of food intake on skin function, including moisturization and skin condition.
Scientific Title:Acronym
A study of healthy adult men and women with dry skin to examine the effects of food intake on skin function, including moisturization and skin condition.
Region
| Japan |
Condition
Condition
Healthy adult men and women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of continuous intake of food containing lactic acid bacteria 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
DLQI
Skin condition questionnaire
Itch VAS, Fatigue VAS
OSA sleep inventory MA version
The Japanese Version of the Constipation Assessment Scale
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 1 grain of test food per day for 12 consecutive weeks
Interventions/Control_2
Intake of 1 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
| 35 | years-old | <= |
Age-upper limit
| 54 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Healthy males and females aged 35 to 54
2. Subjects who are aware of skin dryness and have low level of water content of stratum corneum
Key exclusion criteria
Subjects
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 can 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 consumpting 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 test20.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
80
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Hirose |
Organization
House Wellness Foods Corporation
Division name
Research and Development Institute
Zip code
664-0011
Address
Imoji 3-20, Itami, Hyogo
TEL
072-778-1127
Hirose_Yoshitaka@house-wf.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
House Wellness Foods 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
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
| 2022 | Year | 03 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 08 | 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 | 10 | Month | 30 | Day |
Last modified on
| 2020 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048286
