UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022059
Receipt No. R000025426
Scientific Title Clinical effect of long-time intake of beauty foods in preventing ultraviolet(UV)-induced erythema formation in Japanese subjects -Placebo controlled double-blind trial-
Date of disclosure of the study information 2016/04/25
Last modified on 2016/10/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Clinical effect of long-time intake of beauty foods in preventing ultraviolet(UV)-induced erythema formation in Japanese subjects -Placebo controlled double-blind trial-
Acronym Clinical effect of long-time intake of beauty foods in preventing ultraviolet(UV)-induced erythema formation in Japanese subjects
Scientific Title Clinical effect of long-time intake of beauty foods in preventing ultraviolet(UV)-induced erythema formation in Japanese subjects -Placebo controlled double-blind trial-
Scientific Title:Acronym Clinical effect of long-time intake of beauty foods in preventing ultraviolet(UV)-induced erythema formation in Japanese subjects
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Confirmation of the prevention of UV-induced erythema formation after long-time intake of beauty foods in healthy subjects
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)MED(minimal erythema dose) at 0, 5 weeks after the intake
2)Degree of erythema 1 day after 1.5 MED UV irradiation at 0, 5 weeks after the intake
Key secondary outcomes Degree of melanin formation induced by 1.5 MED UV irradiation at 0, 5 weeks after the intake

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Beauty foods (once a day for 6 weeks)
Interventions/Control_2 Placebo (once a day for 6 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
50 years-old >
Gender Female
Key inclusion criteria 1)Subjects giving written informed consent
2) Healthy women whose age 30 to 49 years old, who were conscious of skin dryness.
3)Subjects whose skin will sunburn (from erythema) easily and develop a tan by UV irradiation
Key exclusion criteria 1)Subjects with history of photo sensitivity
2)Subjects who have chronic diseases and administer treatments and medications
3)Subjects with apparent pigmentation, inflammation, and other diseases in the test area
4)Subjects who have milk or gelatin allergy
5)Subjects who have lactose intolerance
6)Subjects who habitually consume yogurt or fermented milk drink more than 2 times a week
7)Subjects who drink more than 200 mL of milk daily
8)Subjects who use pharmaceuticals, quasi-drugs, dietary supplement effective in the treatment of UV-induced skin pigmentation, rough skin, and arthralgia
9)Subjects who use anti-inflammatory drugs more than once a month
10)Subjects who have excessive sunburn in 2 months
11)Subjects who participated in other clinical trials within a month or plan to participate other clinical trials during this study period
12)Subjects who is in pregnancy, or plan to get pregnant during this study period
13)Subjects who is breast-feeding
14)Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taketo Yamaji
Organization Meiji Co., Ltd.
Division name Food Science Research Laboratories, R&D Division
Zip code
Address 540 Naruda, Odawara, Kanagawa, 250-0862 Japan
TEL 0465-37-3652
Email taketo.yamaji@meiji.com

Public contact
Name of contact person
1st name
Middle name
Last name Tomoyuki Fukasawa
Organization Meiji Co., Ltd.
Division name Food Science Research Laboratories, R&D Division
Zip code
Address 540 Naruda, Odawara, Kanagawa, 250-0862 Japan
TEL 0465-37-3652
Homepage URL
Email tomoyuki.fukasawa@meiji.com

Sponsor
Institute Food Science Research Laboratories, R&D Division, Meiji Co., Ltd.
Institute
Department

Funding Source
Organization Food Science Research Laboratories, R&D Division, Meiji 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
2016 Year 04 Month 25 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
2016 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 30 Day
Last follow-up date
Date of closure to data entry
2016 Year 08 Month 01 Day
Date trial data considered complete
2016 Year 08 Month 03 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 25 Day
Last modified on
2016 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025426

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.