UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039082 |
|---|---|
| Receipt number | R000044575 |
| Scientific Title | A study for skin condition by intake a food to be examined by UV irradiation. -A placebo-controlled, randomized, double-blind, cross-over trial- |
| Date of disclosure of the study information | 2020/01/09 |
| Last modified on | 2020/06/17 09:43:43 |
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Basic information
Public title
A study for skin condition by intake a food to be examined by UV irradiation. -A placebo-controlled, randomized, double-blind, cross-over trial-
Acronym
A study for skin condition by intake a food to be examined by UV irradiation.
Scientific Title
A study for skin condition by intake a food to be examined by UV irradiation. -A placebo-controlled, randomized, double-blind, cross-over trial-
Scientific Title:Acronym
A study for skin condition by intake a food to be examined by UV irradiation.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Hematology and clinical oncology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To consider the effect of taking test food capsules for 8 weeks and until the morning of the 7th day of MED irradiation after taking 8 weeks, on skin color and moisturizing after MED irradiation in comparison with control foods.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. MED judgment by the responsible or assigned doctor.
2. Stratum corneum moisture content.
3. Skin viscoelasticity.
Key secondary outcomes
Conduct VAS on the skin every week during the intake period (9 times in total) for:
Skin viscoelasticity, Skin clarity, Youthfulness (visual impression), Improvement of rough skin, Improvement of fine wrinkles, improvement of dull skin, Improvement of laugh line.
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Take 1 capsule of test food three times a day after breakfast, lunch, and dinner for 8 weeks and until the morning of the 7th day of MED irradiation after taking 8 weeks. Do not take two capsules at once if it was forgotten to take.
Interventions/Control_2
Take 1 capsule of control food three times a day after breakfast, lunch, and dinner for 8 weeks and until the morning of the 7th day of MED irradiation after taking 8 weeks. Do not take two capsules at once if it was forgotten to take.
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
| 45 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Male and female from 30 to 45 years old with no skin disorders.
(2) Subjects with BMI of 18.5 or more and less than 30.
(3) Subjects whose skin photo type is Type I or II
(4) Subjects who can judge UV erythema on the inner skin of the upper arm.
(5) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
(1) Subjects who have been diagnosed with photosensitivity.
(2) Subjects taking drugs that affect skin photosensitivity.
(3) Subjects who are currently visiting a dermatologist or are being treated for other diseases.
(4) Subjects with a history of sugar metabolism, lipid metabolism, liver function, renal function, heart, cardiovascular, respiratory and endocrine systems.
(5) Subjects who regularly take medicines or health foods that are said to have moisturizing and whitening effects.
(6) Subjects with symptoms of atopic dermatitis.
(7) Subjects with significant abnormal skin condition at the test site, or subjects with sunburn.
(8) Subjects with severe hay fever symptoms.
(9) Subjects who continuously use or take anti-inflammatory drugs at least once a month.
(10) Subjects who are using or taking drugs such as oral or liniment because of rough skin.
(11) Subjects with food allergies to olive-containing foods.
(12) Night shift worker or day and night shift workers.
(13) Subjects with a digestive organ disease or surgical history that has an influence on digestive absorption.
(14) Subjects who are judged to be inappropriate as subjects from the answers to the subject background questionnaire.
(15) Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period.
(16) Subjects who has a medical history or current medical history of drug dependence or alcohol dependence.
(17) Subjects who have participated in similar UV irradiation studies within the last two years.
(18) Subjects who participate in other human studies within the last 4 weeks or who plan to participate in other human studied during the period of this study.
(19) Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Kayoko |
| Middle name | |
| Last name | Numano |
Organization
NUMANO CLINIC
Division name
Dermatology
Zip code
150-0013
Address
1-11-2 Ebisu, Shibuya-ku, Tokyo
TEL
03-5793-8712
kaco121@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Sales Department
Zip code
105-0023
Address
7F Shibaura Omodaka Bld., 1-9-7 Shibaura, Minato-ku, Tokyo, Japan
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
MITSUBISHI-CHEMICAL FOODS CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
General Incorporated Association Clinical Research Review Centers
Address
2972-8-603 Ishikawacho, Hachiouji-shi, Tokyo
Tel
090-3547-6398
crrctakashima@kpd.biglobe.ne.jp
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
| 2020 | Year | 01 | Month | 09 | 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
28
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 | 12 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 08 | Day |
Last modified on
| 2020 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044575
