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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018903
Receipt No. R000021876
Scientific Title Clinical evaluation of dietary intake of tomato juice in preventing ultraviolet-induced (UV) erythema formation in Japanese subjects
Date of disclosure of the study information 2015/09/05
Last modified on 2016/03/04

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Basic information
Public title Clinical evaluation of dietary intake of tomato juice in preventing ultraviolet-induced (UV) erythema formation in Japanese subjects
Acronym Preventive effect of tomato juice on UV-induced erythema in Japanese
Scientific Title Clinical evaluation of dietary intake of tomato juice in preventing ultraviolet-induced (UV) erythema formation in Japanese subjects
Scientific Title:Acronym Preventive effect of tomato juice on UV-induced erythema in Japanese
Region
Japan

Condition
Condition UV-induced erythema
Classification by specialty
Dermatology Aesthetic surgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to demonstrate the efficacy of dietary intake of tomato juice in preventing UV-induced erythema in Japanese subjects, and confirm the contribution of lycopene to the effect.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Erythema formation induced by UV radiation at 0, 8, and 12 weeks after beginning the study
Key secondary outcomes Increased level of malondialdehyde in stratum corneum, increased pigmentation, and changes in serum carotenoids (lycopene, beta-carotene, etc. and vitamin E)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Dose comparison
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 tomato juice (once a day for 12 weeks)
Interventions/Control_2 Lycopene-rich tomato juice (once a day for 12 weeks)
Interventions/Control_3 Placebo (once a day for 12 weeks)
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
25 years-old <=
Age-upper limit
50 years-old >
Gender Male and Female
Key inclusion criteria 1) Healthy Japanese Subjects
2) Subjects whose skin will sunburn (form erythema) easily and develop a tan by UV irradiation
Key exclusion criteria 1) Subjects with apparent pigmentation, inflammation, and other diseases in the inside of both upper arms
2) Subjects with history of photo sensitivity
3) Subjects who habitually consume tomato juice or lycopene-rich foods
4) Subjects who use pharmaceuticals and quasi-drugs effective in the treatment of UV-induced skin pigmentation and chloasma
5) Female subjects who is breast-feeding or in pregnancy, or plan to get pregnant during this study period
6) Subjects with risk of allergy regarding to this study
7) Subjects with smoking habit
8) Subjects who habitually consume higher amount of alcohol (> avg 60 g alcohol/day)
9) Subjects who participated in other clinical trials within 2 months.
10) Subjects who are judged unsuitable for this study by principal investigator and doctors.
Target sample size 75

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Suganuma
Organization Kagome Co., Ltd.
Division name Research & Development Division
Zip code
Address 17 Nishitomiyama, Nasushiobara, Tochigi 3292762, Japan
TEL 0287-36-2935
Email Hiroyuki_Suganuma@kagome.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazunori Takashima
Organization Inforward, Inc
Division name Ebisu Skin Research Center
Zip code
Address 1-11-2 Ebisu, Shibuya, Tokyo 1500013, Japan
TEL 03-5447-6411
Homepage URL
Email takashima@inforward.co.jp

Sponsor
Institute Kagome Co. Ltd.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Inforward, Inc
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 株式会社インフォワード恵比寿スキンリサーチセンター(東京都)
Ebisu Skin Research Center, Inforward, Inc (Tokyo)

Other administrative information
Date of disclosure of the study information
2015 Year 09 Month 05 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
2015 Year 08 Month 04 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 10 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
2015 Year 09 Month 03 Day
Last modified on
2016 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021876

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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