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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030195
Receipt No. 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

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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
Email 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
Email t.nakagawa@ttc-tokyo.co.jp

Sponsor
Institute TTC Co., Ltd
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034473

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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