UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015327 |
|---|---|
| Receipt number | R000017817 |
| Scientific Title | A randomized controlled trial for improving effects of test food on skins in women |
| Date of disclosure of the study information | 2014/10/03 |
| Last modified on | 2020/10/01 15:39:23 |
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Basic information
Public title
A randomized controlled trial for improving effects of test food on skins in women
Acronym
A randomized controlled trial for improving effects of test food on skins in women
Scientific Title
A randomized controlled trial for improving effects of test food on skins in women
Scientific Title:Acronym
A randomized controlled trial for improving effects of test food on skins in women
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the test food improves skins in women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Moisture content of the stratum corneum
Skin elasticity
Key secondary outcomes
transepidermal water loss
erythema
total area of wrinkle
skin texture
Analysis of stains, wrinkles, pores, skin color, hidden stains using VISIA
Questionnaires(VAS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test material: test food
1 capsules per day (258mg/day)
Interventions/Control_2
Duration: 12 weeks
Test material: Placebo
1 capsules per day (258mg/day)
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
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
(1)Females aged 30 to 64 years old
(2)Written informed is required
Key exclusion criteria
(1)These prescreened medicine.
(2)These having Food for Specified Health Uses (FOSHU) and/or health food.
(3)Subjects who have previous medical history and/or current medical history of serious diseases (e.g., heart, liver, kidney and/or digestive organ).
(4)Pregnant women, lactating women, or women who want to get pregnant during the trial period
(5)Heavy alcohol drinker.
(6)Those that have extremely disheveled lifestyle and/or dietary habits.
(7)Subjects who have previous medical history of drug and/or food allergy.
(8)Subjects who have skin allergy such as the atopy.
(9)Subjects with more than of number of cigarettes smoked an average of 21 per day
(10)Subjects who have been participated in another trial or other investigational and/or enrolled in the other clinical trials within about last 1 month.
(11)Subjects who have treated cosmetic care(e.g., electric facials, esthetic, peeling and/or laser medical treatment).
(12)Subjects who have donated over 200 mL of blood and/or blood components within the last one month prior to the current study.
(13)Subjects who have donated over 400 mL of blood and/or blood components within the last four months prior to the current study.
(14)Subjects who collected blood amount of blood sampling over 800 mL within the last twelve months prior to the current study and this clinical trial's blood sampling.
(15)Subjects who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Katsuhisa |
| Middle name | |
| Last name | Sakano |
Organization
CPCC Co.,Ltd.
Division name
Clinical Research Planning Department
Zip code
101-0047
Address
4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL
03-5297-3112
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Co.,Ltd.
Division name
Plan Sales Department
Zip code
101-0047
Address
4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
WAKASA SEIKATSU 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
Tel
03-2597-5548
IRB@cpcc.co.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
| 2014 | Year | 10 | Month | 03 | 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
| 2014 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | 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 | 10 | Month | 02 | Day |
Last modified on
| 2020 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017817
