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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036688
Receipt No. R000041809
Scientific Title Ultraviolet ray prevention effect by intake of health food containing pomegranate origin ellagic acid, flavangenol : Parallel group comparison study
Date of disclosure of the study information 2019/05/10
Last modified on 2019/05/09

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Basic information
Public title Ultraviolet ray prevention effect by intake of health food containing pomegranate origin ellagic acid, flavangenol
Acronym UV prevention trial
Scientific Title Ultraviolet ray prevention effect by intake of health food containing pomegranate origin ellagic acid, flavangenol : Parallel group comparison study
Scientific Title:Acronym UV prevention trial
Region
Japan

Condition
Condition Healthy adult female
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Take test article for 12 weeks and evaluate the effect of ultraviolet ray prevention
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes measurement of skin brightness, number of skin spots
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Take test food for 12 weeks.
Interventions/Control_2 No intervention
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
59 years-old >=
Gender Female
Key inclusion criteria 1.Subjects cares about spots and dullness
2.Subject who cares skin spots due to sunburn
Key exclusion criteria 1. Subjects who has UV allergy
2. Subjects who is hard to get sunburn
3. Subjects who will be tanned during the study
4. Subjects who is sunburning regularly
5. Subjects who are pregnant or nursing
6. Subjects who are currently outing to the hospital or treated by a doctor's treatment
7. Subjects who has food allergy
8. Subjects who has experience of cosmetic medicine at the test site
9. Subjects with inflammation or skin disease on the face
10. Subjects undergoing hormone replacement therapy
11. Subjects who take supplements or drugs that affect the effects of the test product
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Masatomo
Middle name
Last name Najima
Organization Japan Clinical Trial Association
Division name N.A.
Zip code 1600022
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Email info@yakujihou.org

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Kaneko
Organization Japan Clinical Trial Association
Division name N.A.
Zip code 1600022
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Homepage URL
Email info@yakujihou.org

Sponsor
Institute Japan Clinical Trial Association
Institute
Department

Funding Source
Organization Vitabrid Japan Inc.
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 Pharmaceutical Law Wisdoms
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel 0364574911
Email master@yakujihou.net

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
2019 Year 05 Month 10 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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 18 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 10 Day
Last follow-up date
2019 Year 08 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 09 Day
Last modified on
2019 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041809

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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