UMIN-CTR Clinical Trial

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	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	19
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	2019 Year 04 Month 18 Day
Date of IRB	2019 Year 04 Month 18 Day
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	2020 Year 04 Month 13 Day

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