UMIN-CTR Clinical Trial

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
Institute	FANCL Corporation
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049167