UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024014 |
|---|---|
| Receipt number | 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 17:59:05 |
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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
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
hemmi.takahiro@matsumoto-trd.co.jp
Sponsor or person
Institute
Ezaki Glico Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027645
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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