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 UMIN000039082
Receipt No. 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

* 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 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
Email 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
Email eigyou27@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044575

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.