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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014325
Receipt No. R000016677
Scientific Title A study on the effects of a dietary supplement intake on skin in adult female who feel dry skin
Date of disclosure of the study information 2014/06/20
Last modified on 2014/12/01

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Basic information
Public title A study on the effects of a dietary supplement intake on skin in adult female who feel dry skin
Acronym A study on the effects of a dietary supplement intake on skin in adult female who feel dry skin
Scientific Title A study on the effects of a dietary supplement intake on skin in adult female who feel dry skin
Scientific Title:Acronym A study on the effects of a dietary supplement intake on skin in adult female who feel dry skin
Region
Japan

Condition
Condition Dry skin
Classification by specialty
Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A study on the effects of supplement containing collagen intake on skin
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Moisture content of the stratum corneum, transepidermal water loss
Key secondary outcomes Skin questionnaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
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 Ingestion of placebo powder for 8 consecutive weeks
Interventions/Control_2 Ingestion of powder containing collagen 5,000mg per a 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
59 years-old >=
Gender Female
Key inclusion criteria 1. Healthy females between the ages of 30 and 59
2. Subjects who feel dry skin in the screening test
3. Lower level of transepidermal water loss
Key exclusion criteria 1. Having dietary supplements, medicines, skin care preparation which include collagen, ceramide, hyaluronan-rich, or have had dietary supplements wchich have high effect on skin more than 3 times a week within the last one month prior to the screening test
2. Treated cosmetic care which affects mesuring site
3. Treated cosmetic care except for measuring sites, or hormonal therapy within the last one month prior to the screening test
4. Got a facial, a wash-rag, lost hair on measuring sites, or plan these actions within the last one month prior to the screening test
6. Planning to get a tan between the last one month prior to the screening test and the completion of the test within the last one month prior to the screening test
6. Washing the body using nylon a towel which provides strong skin irritation except for a soft towel
7. Having the wound or inflammatory disease affecting the measuring skin
8. Developing atopy or asthma, or have the its possibility
9. Feeling to trouble by rough skin around a menstruates
10. Employing on a pre-dawn shift or on night duty more than 2 times in the current stugy term
11. Being in development of diabetes, liver disease, kidney disease, or diseases affecting a secretion of sex hormones, or have its previous history
12. Having the medicines constantly
13. Developed hay fever between December and March in the past 3 years, or being expected to be developed the allergy symptoms on skin
14. Participated in other clinical study or are planned to participate in other clinical study after informed consent for the current study
15. Judged as unsuitable for the study based on the results of clinical and physical examination
16. Planning to become pregnant or lactate
17. Planning to go overseas
18. Took a blood sample or donated blood beyond the limit within the last one year prior to the screening test
19. Judged as unsuitable for the study based on the results of lifestyle questionnaire
20. Judged as unsuitable for the study by physician
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name KONDO Sumio
Organization Medical Corporation Kenshokai, Fukushima Healthcare Center
Division name Internal medicine
Zip code
Address 2-12-16, Tamagawa, Fukushima-ku, Osaka
TEL 06-6441-6848
Email ko283434@ares.eonet.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name NAKAGAWA Takashi
Organization Total Technological Consultant Co., Ltd.(TTC)
Division name Clinical Research Planning Dept.
Zip code
Address 1-20-2 Ebisu Nishi, Shibuya-ku, Tokyo, Seibu Shinyokinko Ebisu Bldg
TEL 03-5459-5329
Homepage URL
Email t.nakagawa@ttc-tokyo.co.jp

Sponsor
Institute Total Technological Consultant Co., Ltd.(TTC)
Institute
Department

Funding Source
Organization Shinnihonseiyaku 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
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
2014 Year 06 Month 20 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
2013 Year 11 Month 23 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 03 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
2014 Year 06 Month 20 Day
Last modified on
2014 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016677

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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