UMIN-CTR Clinical Trial

Public title

The inhibitory effects on UV-induced skin deterioration by long-term ingestion of test food in human: a double-blind, randomized placebo-controlled, parallel comparison study

Acronym

The inhibitory effects on UV-induced skin deterioration by long-term ingestion of test food in human

Scientific Title

The inhibitory effects on UV-induced skin deterioration by long-term ingestion of test food in human: a double-blind, randomized placebo-controlled, parallel comparison study

Scientific Title:Acronym

The inhibitory effects on UV-induced skin deterioration by long-term ingestion of test food in human

Region

Japan

Condition

Healthy volunteers

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effects of test food on UV-induced skin deterioration

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

MED

Key secondary outcomes

Skin condition
Safety evaluation

Study type

Interventional

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. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of test food for 9 weeks

Interventions/Control_2

Ingestion of placebo for 9 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

Age-lower limit

30

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Subjects aged from 30 to 59 years old at the time informed consent is provided.
2) Subjects whose skin phototype is type II or type III.
3) Subjects who accept the analysis for UV-induced erythema in their back skin.
4) Subjects whose basement MED is judged as second, third or fourth points in six-grade UV-irradiated area.
5) Subjects who can visit to the administrative facility on every inspection day.
6) Subjects who provide the written informed consent for the involvement of this trial by themselves.

Key exclusion criteria

1)Subjects with photosensitivity disorder
2)Subjects who take medicine that affect light sensitivity of skin
3)Subjects who regularly go to a dermatology office
4)Subjects who continuously take a functional food or a quasi-medicine which has same or similar effect with ingredient of test food
5)Subjects who continuously take medicine, quasi-medicine, functional food or supplement which advocate or emphasize efficacy for which is evaluated in the trial, or which is related to joint pain
6)Subjects who have skin disease or abnormality in skin condition such as atopic dermatitis
7)Subjects who show apparent change of skin condition that is not related to test food at the end of trial compared with the initiation
8)Subjects who take anti-inflammatory medicine at least once a month
9)Subjects who work on night shift or day and night shift
10)Subjects who receive medical or prophylactic treatment, or who require medical treatment
11)Subjects who have a past history for severe disease or abnormality in glucose or lipid metabolism, liver or kidney function, cardiovascular, respiratory, endocrine or nerve system, or for psychiatric disorder
12)Subjects who have a past history of alcoholism or drug addiction
13)Subjects who have risk for food allergy
14)Subjects who frequently intake food which is rich in same ingredient of test food, or who intake these kind of food during 3 days before and after trial initiation and last 3 days from the end of trial
15)Subjects who frequently intake food which might affect skin color
16)Subjects who show abnormality in blood test, or who are positive for HBs antigen or HCV antibody
17)Subjects who are pregnant or during lactation when the informed consent is provided, or who hope to become pregnant
18)Subjects who were involved in another trial within 4 weeks prior to the trial, or who will participate in another trial
19)Subjects who are judged to be inappropriate for the trial by the responsible doctor

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Dr. Sumio Kondo

Organization

Medical Corpoation Kenshokai Fukushima Healthcare Center

Division name

Medical Corpoation Kenshokai Fukushima Healthcare Center

Zip code

Address

2-12-13, Tamagawa, Fukushima-ku, Osaka, Japan

TEL

81-(0)6-6882-1130

Email

s.kondo@drc-web.co.jp

Name of contact person

1st name
Middle name
Last name	Yuri Okano

Organization

CIEL Corporation

Division name

CIEL Corporation

Zip code

Address

Renafine 302, 2-10-11, Midori, Sumida-ku, Tokyo

TEL

03-6659-2767

Homepage URL

Email

yuri.okano@ciel-tokyo.com

Institute

DRC Corporation, Ltd.
Product Testing Department

No.9 Tabuchi Bldg. 3F, 2-10-31, Higashi-Temma, Kita-ku, Osaka
Tel: 81-(0)6-6882-1130

Institute

Department

Personal name

Organization

FUJIFILM Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

03

Month

30

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.mdpi.com/2072-6643/10/7/817/htm

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

08

Month

18

Day

Date of IRB

Anticipated trial start date

2017

Year

09

Month

19

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

08

Month

31

Day

Last modified on

2018

Year

09

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033101