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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024014
Receipt No. R000027645
Scientific Title Verification of the anti UV-induced inflammation effect of a plant extract ingredient. (Randomized, double-blind, placebo-controlled, parallel-group study)
Date of disclosure of the study information 2016/09/13
Last modified on 2017/04/01

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Basic information
Public title Verification of the anti UV-induced inflammation effect of a plant extract ingredient.
(Randomized, double-blind, placebo-controlled, parallel-group study)
Acronym Verification of the anti UV-induced inflammation effect of a plant extract.
Scientific Title Verification of the anti UV-induced inflammation effect of a plant extract ingredient.
(Randomized, double-blind, placebo-controlled, parallel-group study)
Scientific Title:Acronym Verification of the anti UV-induced inflammation effect of a plant extract.
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare and investigate the suppressive effect on UV-induced inflammation before and after the consumption of a test food, using placebo as control.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Minimal Erythema Dose
Minimal Tanning Dose
Skin color (L*, a*) on the UV-irradiated region.
Stratum corneum hydration and Transepidermal water loss on the UV-irradiated region.
Key secondary outcomes Skin color (L*, a*)
Stratum corneum hydration
Transepidermal water loss

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 once a day for five weeks
Interventions/Control_2 Placebo capsule once a day for five 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 Male and Female
Key inclusion criteria 1) Men and women aged >= 30 to <50 years
2) Those fall under the category of Fizpatrick skintype II
Key exclusion criteria 1) Those with a diagnosis of photosensitive disorder.
2) Those who take drugs which affect skin photosensitivity.
3) Those with diagnosis of diseases on the measurement region by a medical advice.
4) Those whose MED was not detected in the measurements.
5) Those who have treated for beauty on the measurement region.
6) Those who routinely take foods, supplements and cosmetics that contain the same active ingredient.
7) Those who have treated for special skincare on the mesurement region or who have a plan to have the treatment within past 4 weeks.
8) Those who changed healthy foods or external preparation including basic skin-care products that use for measurement region, or who have begun usage of them within past 4 weeks.
9) Those who was exposed to exceeded UV-light than in daily life by activities including long hours of outwork, sports, sea bathing and leisure activities, or who have a plan it during the study period.
10) Those who engage in the night work and work in shifts day and night.
11) Those who are receiving the treatments to treat or prevent disease at medical institution at the time of receiving informed consent, or who have need of those therapy.
12) Those who have serious disorders of carbohydrate metabolism, lipid metabolism, liver function, kidney function, heart, cardiovascular, respiratory organs, endocrine system and nervous system, or with a history of psychiatric disorder.
13) Those with a history of alcoholic and drug dependency.
14) Those with allergies to cosmetics or foods.
15) Pregnant women, those who may be pregnant, lactating women at the time of receiving informed consent, or women who hope to become pregnant during the study period.
16) Those who have participated in other human studies similar to the study within past 2 months.
17) Those who have participated in other human studies within the past 4 weeks, or who plan to participate.
18) Those who were considered inappropriate for the study by an investigator.





Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Takaha
Organization Ezaki Glico Co., Ltd.
Division name Institute of Health Sciences, Material Science Group
Zip code
Address 4-6-5 Utajima, Nishiyodogawa, Osaka 555-8502, JAPAN
TEL 06-6477-8425
Email takaha-takeshi@glico.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Hemmi
Organization Matsumoto Trading Co., Ltd.
Division name Safety Study Trust Dept.
Zip code
Address 1-13-7, Nihonbashi-Muromachi, Chuo-ku, Tokyo, Japan
TEL 03-3241-5162
Homepage URL
Email hemmi.takahiro@matsumoto-trd.co.jp

Sponsor
Institute Ezaki Glico 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
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 09 Month 13 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 08 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 27 Day
Last follow-up date
2016 Year 11 Month 08 Day
Date of closure to data entry
2017 Year 03 Month 27 Day
Date trial data considered complete
2017 Year 03 Month 27 Day
Date analysis concluded
2017 Year 03 Month 27 Day

Other
Other related information

Management information
Registered date
2016 Year 09 Month 12 Day
Last modified on
2017 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027645

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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