UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030195 |
|---|---|
| Receipt number | R000034473 |
| Scientific Title | A study for the skin moisturizing effect of a dietary supplement intake on in adult female who are aware of skin dryness |
| Date of disclosure of the study information | 2017/11/30 |
| Last modified on | 2018/10/29 15:28:44 |
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Basic information
Public title
A study for the skin moisturizing effect of a dietary supplement intake on in adult female who are aware of skin dryness
Acronym
A study for the skin moisturizing effect of a dietary supplement intake
Scientific Title
A study for the skin moisturizing effect of a dietary supplement intake on in adult female who are aware of skin dryness
Scientific Title:Acronym
A study for the skin moisturizing effect of a dietary supplement intake
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A study for the skin moisturizing effect of a dietary supplement intake for 12 weeks
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stratum corneum water content (4, 8, and 12 weeks after a dietary supplement intake)
Key secondary outcomes
Skin elasticity, collagen score, questionnaires and VISIA (4, 8, and 12 weeks after a dietary supplement intake)
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 test food for 12 consecutive weeks
Interventions/Control_2
Intake of placebo 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
| 20 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Females between the ages of 20 and 64
2. Subjects who are aware of skin dryness and lower level of Stratum corneum water content
Key exclusion criteria
1. Subjects who usually take some drugs, functional foods, or cosmetics including active ingredients
2. Subjects who usually take some drugs, functional foods, etc. which would affect skin condition
3. Subjects who got some cosmetic surgery, or hormone therapy which would affect the target skins
4. Subjects who plan to have ultraviolet exposure within a month before the screening test
5. Subjects who wash the target skin providing strong skin irritation
6. Subjects who usually use bath additives
7. Subjects who have the wounds or inflammatory diseases which would affect the target skin
8. Habitual smokers
9. Subjects who might have allergic symptoms and use medicines in this study
10. Subjects who feel skin roughness on the target skin around a menstruates
11. Subjects who employ on a pre-dawn shift or on night duty more than 2 times in this study
12. Subjects who are plan to go overseas
13. Subjects who have asthma or would have asthma during this study
14. Subjects who have severe diseases or diseases which affect a secretion of sex hormones
15. Subjects who are at risk of having allergic reaction related to this study
16. Subjects who have diseases affecting this study
17. Subjects who judged as unsuitable based on the results of clinical and physical examination
18. Subjects who participated other clinical trial within 3 months prior to this study or plan to participate other clinical trial after acquiring consent to this study
19. Pregnant or lactating subjects
20. Subjects who are judged as unsuitable for this study by the principal investigator
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sumio Kondo |
Organization
Medical Corporation Kensho-kai, Fukushima Healthcare Center
Division name
Internal Medicine,Department of Neurosurgery
Zip code
Address
2-12-16 Tamagawa, Fukushima-ku, Osaka-shi, Osaka, 553-0004
TEL
06-6441-6848
s.kondo@drc-web.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Nakagawa |
Organization
TTC Co., Ltd
Division name
Clinical Research Planning Department
Zip code
Address
1-20-2 Ebisunishi, shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
t.nakagawa@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Non Disclosure
Organization
Division
Category of Funding Organization
Self funding
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
| 2017 | Year | 11 | Month | 30 | 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
| 2017 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | 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
| 2017 | Year | 11 | Month | 30 | Day |
Last modified on
| 2018 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034473
