UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043096
Receipt number R000049167
Scientific Title Inhibitory effect of the test food on ultraviolet-induced skin damage. -A randomized, double blinded, placebo controlled, parallel group comparison study-
Date of disclosure of the study information 2021/01/24
Last modified on 2021/08/24 11:14:00

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Basic information

Public title

Inhibitory effect of the test food on ultraviolet-induced skin damage. -A randomized, double blinded, placebo controlled, parallel group comparison study-

Acronym

Inhibitory effect of the test food on ultraviolet-induced skin damage.

Scientific Title

Inhibitory effect of the test food on ultraviolet-induced skin damage. -A randomized, double blinded, placebo controlled, parallel group comparison study-

Scientific Title:Acronym

Inhibitory effect of the test food on ultraviolet-induced skin damage.

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study examines effects of test food on ultraviolet-induced skin damage.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Minimal erythema dose (MED)

Key secondary outcomes

Minimal tanning dose (MTD)
Skin color (L*, a*), Melanin index
Subgroup analysis based on baseline MED, skin photo type and gender


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1. Healthy Japanese male and female aged between 19 and 60 at the time of informed consent
2. Subjects whose Fitzpatrick skin phototype is type II or type III
3. Subjects who can come on the designated inspection day and can be inspected
4. Subjects who have received a sufficient explanation of the purpose and contents of the examination, have the ability to make a self-judgment, voluntarily participate in the study after understanding the content enough and agree to participate in the study by signing the written informed consent
5. Subjects who do not meet the exclusion criteria

Key exclusion criteria

1. Subjects with photosensitivity disorder
2. Subjects taking medicine that may affect light sensitivity of the skin
3. Subjects taking anti-inflammatory medicine at least once a month, or who are planning to take them during the study period
4. Subjects who may suffer from seasonal allergy symptoms such as hay fever, and take medicine for them.
5. Subjects who have symptoms of skin diseases on the evaluation site which may affect the test results
6. Subjects who have symptoms of indigestion
7. Subjects with a digestive organ disease or surgical history that affects digestion and absorption
8. Subjects who smoke or have smoked within the last one year prior to the current study
9. Subjects who have excessive drinking habits
10. Subjects who may develop allergies related to the present study
11. Subjects who routinely use medicine, supplements, FOSHU, and/or food which may affect the results or who are planning to take them during the study period
12. Subjects who are undergoing skin related treatment at dermatology
13. Subjects who are undergoing medical treatment or who requires medical or prophylactic treatment at the time of informed consent
14. Subjects who have or had a medical history of serious hepatopathy, kidney damage, heart disease, hematological or blood disease
15. Subjects who is planning to have major lifestyle changes during the study period
16. Subjects who are likely to be exposed to exceeded UV-light for a long time during the study period
17. Shift workers
18. Subjects who have participated in other human studies within the past one month
19. Subjects who have used external preparations, cosmetology, or treatment history that may affect the test results on the measurement sites within the past one month
20. Subjects who are pregnant or lactating, or who intend to become pregnant
21. Subjects who are judged as unsuitable participant by the doctor for other reasons

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Kei
Middle name
Last name Yui

Organization

FANCL Corporation

Division name

Research Institute, Health science research center

Zip code

244-0806

Address

12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan

TEL

045-820-3755

Email

ke-yui@fancl.co.jp


Public contact

Name of contact person

1st name Yuka
Middle name
Last name Anno

Organization

Nikoderm Research Inc.

Division name

Evaluation Division

Zip code

541-0052

Address

1-6-14 Azuchimachi,Chuo-ku,Osaka City, OSAKA, Japan

TEL

06-6125-3501

Homepage URL


Email

anno@nikkolgroup.com


Sponsor or person

Institute

FANCL Corporation

Institute

Department

Personal name



Funding Source

Organization

FANCL Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Society of Glycative Stress Research

Address

5F-11,Musashino Bldg,2-13-10 Shinjuku,Shinjuku-ku,Tokyo

Tel

03-6709-8842

Email

info@toukastress.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

株式会社ニコダームリサーチ(大阪府)
医療法人共創会 AMC西梅田クリニック


Other administrative information

Date of disclosure of the study information

2021 Year 01 Month 24 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

2020 Year 12 Month 21 Day

Date of IRB

2020 Year 12 Month 29 Day

Anticipated trial start date

2021 Year 01 Month 25 Day

Last follow-up date

2021 Year 04 Month 08 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 01 Month 22 Day

Last modified on

2021 Year 08 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049167


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name